Astrazeneca Plc · LSE:AZN
Astrazeneca — Investor Presentation (September 2010)
132 slides from Astrazeneca's investor presentation, September 2010
Slide 1: General Presentation September 2010
General Presentation September 2010
Slide 2: Contents
Contents Page 1. Corporate Strategy 3 2. 1H 2010 Performance & Products 9 3. R&D Update 42 4. Strategy update & Planning assumptions 2010+ 85 5. Key industry growth drivers 102 6. Legal & Patent update 122 7. News flow 2H 2010 128 8. Investor Relations contacts 131 2 2
Slide 3: Corporate Strategy
Corporate Strategy Strategy
Slide 4: Our vision
Our vision AstraZeneca is Focused Integrated Innovation-driven Global OUR VALUES 4 Strategy 4
Slide 5: Strategic priorities
Strategic priorities 5 Strategy 5
Slide 6: Business Growth
Business Growth Strategic Initiatives • Grow market share of key brands that retain exclusivity: Planning assumptions 2010-2014 - Crestor - Seroquel XR • Revenue in the range - Symbicort of $28bn to $34bn per annum over the period • Successfully commercialise recent launches and the next wave • Risk
Slide 7: Business Shape
Business Shape 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 - Qual
Slide 8: Cash generation & Investment
Cash generation & Investment Reinvest 40 to 50% of Business focus on cash after-tax pre-R&D cash Residual cash flow flow generation flow to drive future available for growth and value • Achieving revenue and • Internal and external • Specific business Core pre-R&D margins R&D needs in planning range
Slide 9: 2Q & 1H 2010 Performance
2Q & 1H 2010 Performance Performance
Slide 10: 1H 2010 Summary
1H 2010 Summary • Strong financial performance - Revenue $16,754m (+4% CER) - Core EPS $3.82 (+16% CER) • Pipeline - Brilinta CABG data presented at ACC - Strong growth of Crestor, Symbicort and & FDA Advisory committee also in Emerging markets • New launches • New external collaboration - Fostamati
Slide 11: Headline results 1H 2010
Headline results 1H 2010 2010 2009 Actual CER $m $m growth growth Sales 16,754 15,659 +7% +4% Core Operating Profit 7,507 6,968 +8% +5% Core EPS $3.82 $3.22 +19% +16% Restructuring ($0.30) ($0.13) MedImmune/Merck amortisation ($0.14) ($0.13) Legal provisions ($0.01) ($0.30) Reported EPS $3.37 $2.66
Slide 12: Headline results 2Q 2010
Headline results 2Q 2010 2010 2009 Actual CER $m $m growth growth Revenue 8,178 7,958 +3% +1% Core Operating Profit 3,650 3,606 +1% - Core EPS $1.79 $1.64 +9% +9% Restructuring ($0.25) ($0.10) MedImmune/Merck amortisation($0.07) ($0.06) Legal provisions ($0.01) ($0.30) Reported EPS $1.46 $1.18 +24%
Slide 13: Regional revenue performance 2Q 2010
Regional revenue performance 2Q 2010 2Q 2010 CER $m growth Global Revenue 8,178 +1% US 3,396 -4% Western Europe 2,213 +1% Established ROW 1,277 +4% Emerging Markets 1,292 +16% 13 Performance 13
Slide 14: Shareholder Distributions
Shareholder Distributions • Progressive dividend policy - Maintain or grow dividend each year - Annual dividend to reflect earnings prospects over entire cycle, not just one year in isolation & Cover may vary, with target of an average of 2-times cover (ie 50% payout ratio) over the cycle, based on
Slide 15: Guidance for 2010 (Core basis)
Guidance for 2010 (Core basis) Revenue Low single-digit decline at CER Gross Margin around the Q1 run rate of 81% Core Pre-R&D Margin Near top of mid-term planning range Net Finance Expense ~$550m Other Operating Income less than FY2009 of $926m Tax Rate ~27% Core EPS Range $6.35 to $6.65 15 Perform
Slide 16: 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 - $1 = JPY 91.4 • Actual 2010 rates may differ materially from January 2010 rates upon which guidance is based • 2010 currency sensitivity estimator is available at www.astrazene
Slide 17: Estimated impact of currency movements on sales and earnings
Estimated impact of currency movements on sales and earnings Estimated impact of a 10% appreciation of the respective currency against the USD Sales Core earnings EUR 2.3% 4.1% GBP 0.3% -1.8% SEK 0.1% -2.3% JPY 0.6% 0.6% Other Currencies 2.4% 4.2% TOTAL 5.7% 4.8% 17 Performance 17
Slide 18: Product Performance
Product Performance 18 Performance 18
Slide 19: AZ presence in 9 of top 10 therapeutic categories
AZ has successful products or key late stage assets in 9 of the top 10 therapeutic categories globally Rank Therapeutic Category 2009 Category Current AZ Presence value ($bn) Arimidex, Casodex, Zoladex, 1 ONCOLOGY 49.9 Faslodex, Iressa CHOLESTEROL & TRIGLYCERIDE Crestor 2 REGULATION 31.2 Nexium & Pr
Slide 20: Key Brand revenue summary: 2Q2010
Key Brand revenue summary: 2Q2010 2Q 2010 CER $m % Crestor 1,430 +23 Seroquel 1,352 +8 Nexium 1,257 - Symbicort 664 +20 Arimidex 439 -10 20 Performance 20
Slide 21: Crestor
Crestor 2Q10 Sales: $1,430m +23% EM ROW $155m +28% US EST ROW • US TRx +12% $320m +20% – 4 times statin market W. EUR $276m +22% • US TRx share 11.8% in June • Dynamic share >16% – Second only to Simvastatin US $679m +24% ROW • ROW sales $751m +22% • Volume growth 3 times statin market 2Q 09 2Q 10 U
Slide 22: 4-Week TRx Growth
4-Week TRx Growth -50% -40% -30% -20% -10% 0% 10% 20% 30% 40% 18/01/2008 50% 15/02/2008 14/03/2008 11/04/2008 09/05/2008 06/06/2008 04/07/2008 Market 01/08/2008 Vytorin 29/08/2008 26/09/2008 24/10/2008 21/11/2008 19/12/2008 16/01/2009 13/02/2009 Source: IMS NPA – Data week ending 7/16/10 13/03/2009
Slide 23: Strong positioning is driving Crestor preference
Strong positioning is driving Crestor preference 1st Treatment Choice For At-Risk Patient Statin Would Recommend To Family Among Total Physicians Member With Dyslipidemia Among Total Physicians Q3 ‘08 Q1 ‘10 Q2 ‘10 Q308 Q2’10 (n=914) (n=923) (n=914) (n=973) (n=914) CRESTOR 30% 51% 54% 31% 54% Lipito
Slide 24: GALAXY programme hypothesis
GALAXY programme hypothesis Effects on lipid profile STELLAR METEOR Profound benefits on atherosclerosis ASTEROID SATURN* Reductions in CV morbidity and mortality JUPITER * Reports in 2011 24 Performance 24
Slide 25: 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 26: Crestor – Proven to slow the progression of atherosclerosis
Crestor – Proven to slow the progression of atherosclerosis •Label indication - Approved in US Nov 2007 - ‘Proven to slow the progression of atherosclerosis’ 26 Performance 26
Slide 27: JUPITER outcomes study
JUPITER outcomes study 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 cholesterol
Slide 28: JUPITER Primary Endpoint
JUPITER Primary Endpoint: MI, Stroke, UA/Revasc., CV Death 0.08 HR 0.56, 95% CI 0.46-0.69 Placebo 251 / 8901 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 29: JUPITER summary of results
JUPITER summary of results Efficacy Safety Among apparently healthy men and women • No increase in serious adverse events with elevated hsCRP but low LDL compared to placebo • Crestor reduced by 47 percent the incidence of myocardial infarction, stroke, • No increase in myopathy, cancer, and cardiov
Slide 30: 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 31: Seroquel
Seroquel 2Q10 Sales: $1,352m +8% • Seroquel IR: $1,049m -5% • Seroquel XR: $303m +92% EM ROW $90m +17% EST ROW $78m +27% US W. EUR • TRx +70 basis points/market +120 bps $219m -2% • Market leading TRx share 31%, -36 bps • Seroquel XR now 15% of franchise TRx’s US $965m +8% ROW • Sales $387m +6% • Se
Slide 32: Seroquel LCM update
Seroquel LCM update Regulatory update: Filed Approved US IR Bipolar Depression IR Bipolar Maintenance XR Schizophrenia XR Bipolar Mania XR Bipolar Depression XR Bipolar Maintenance XR Major Depressive Disorder * XR Generalised Anxiety Disorder CRL* EU IR Bipolar Depression IR Bipolar Maintenance XR
Slide 33: 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 Size of 400mg3 150mg2 600mg3 Patient population 9 months1 7-8 months1 4-8 months1 Average treatment duration 1. IMS Longitudinal
Slide 34: Nexium
Nexium 2Q10 Sales: $1,257m 0% US • Retail volume -5% EM ROW • Steady share of Dispensed Units $152m +18% EST ROW – -6 bps vs Dec 2009 $111m +2% • Supported by new promotional channels W. EUR $299m 0% – Customer service associates – Inside telephone sales US – Digital $695m -4% • Avg realised prices
Slide 35: Symbicort
Symbicort 2Q10 Sales: $664m +20% US EM ROW $88m +18% • TRx +57% EST ROW $60m +38% • NRx share 18.8% – Up ~5 pts vs June 09 W. EUR • New Start share 27% $335m +3% ROW • Sales $483m +9% US $181m +63% • Good launch in Japan 2Q 09 2Q 10 US W EUR EST ROW EM ROW 35 Performance 35
Slide 36: Symbicort: Steady share growth in US since launch
Symbicort: Steady share growth in US since launch COPD Launch 36 Performance 36
Slide 37: Arimidex
Arimidex 2Q10 Sales: $439m -10% US • Multiple generics approved following EM ROW $38m -3% 27 June patent expiry EST ROW $72m 0% • Q2 includes provision against pipeline inventory W. EUR $144m -5% ROW US • Sales extensions on completed $185m -17% Paediatric Investigation Plan (PIP) – Extends exclusiv
Slide 38: ONGLYZA – A new medication for diabetes in a growing class
ONGLYZA – A new medication for diabetes in a growing class • ONGLYZA approved in the US on 31 July 2009 - 2nd DPP-IV inhibitor on the US market - CV event study started in Q2 2010 • Approved in the EU in October 2009 - 3rd DPP-IV inhibitor on the EU market • FDC of ONGLYZA & metformin submitted in U
Slide 39: ONGLYZA reductions in HbA1c, FPG, PPG at Week 24
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 40: ONGLYZA launch summary
ONGLYZA launch summary • US - Leading launch indicators solid • ONGLYZA has gained rapid formulary access and is available at tier 1 or 2 for over 60% of covered lives and without a prior authorization for over 80% of covered lives. • Profile as an effective and safe DPP4 is being established • 1/6
Slide 41: ONGLYZA US market share performance
ONGLYZA US market share performance Onglyza DPP4 Share (Unequivalized) Onglyza Share of New DPP4 Patients Note: New DPP4 patient share is based on patients who have not received any DPP4 in the last 12 months. Source: IMS National Audit & LRx, Report Date: April 5th 2010 41 Performance Onglyza and d
Slide 42: R&D
R&D R&D
Slide 43: A changing landscape requires continuous R&D evolution
A changing landscape....requires continuous R&D evolution • Challenges - Pricing and market access - Tougher regulatory environment - Generic threat and patent expiry • Opportunities - Breakthroughs in science - Ageing patient populations - Unmet medical needs • Our R&D strategy - Enhance key capabi
Slide 44: 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 45: 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 46: Discovery productivity improved
Discovery productivity improved More candidates More reaching first entering development time in man (FTIM) 40 24 3 35 8 20 2 30 7 8 16 1 25 20 12 21 15 28 18 24 26 8 16 10 22 12 15 14 17 10 9 5 10 4 6 8 8 4 0 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2001 2002 2003 2004 2005 2006 2007 2008 200
Slide 47: Pipeline growth reaching steady state
Pipeline growth reaching steady state 146 146 137 144 14 13 120 24 23 11 10 106 10 91 10 25 34 34 25 25 20 31 5 5 6 18 13 13 41 44 40 34 17 17 23 31 45 49 42 46 43 49 FY2004 FY2005 FY2006 FY2007 FY2008 FY2009 HY2010 Pre-clinical Phase I Phase II Phase III/Reg LCM 47 R&D 47
Slide 48: Late stage pipeline
Late stage pipeline Filed 2009 Potential Filings 2010 Filing Opportunities 2011-14 Lesogaberan Vimovo Dapagliflozin Zibotentan AZD3355 Certriad Ceftaroline Dapa / Metformin FDC CAZ104 Vandetanib MTC Brilinta (orphan) TC-5214 CytoFab ONGLYZA / Metformin NKTR-118 AZD6244 FDC FosD AZD6765 Therapy Areas
Slide 49: Prevalence of Acute Coronary Syndromes (ACS)
Prevalence of Acute Coronary Syndromes (ACS) ~3.5 million >1.4 million About every 26 seconds, an American will suffer episodes of ACS Hospitalisations a coronary event reported in the for ACS in the US major 7 markets in 2005 (EU*, US, Japan) in 2005 About every minute, an American will die from a
Slide 50: Brilinta (ticagrelor) for ACS
Brilinta (ticagrelor) for ACS Next generation anti-platelet therapy • First reversibly binding oral ADP-receptor antagonist • Direct-acting; does not require metabolic activation • Rapid onset (within 30min); peak plasma levels within 2–3 hours • Greater & more consistent inhibition of ADP-induced p
Slide 51: 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 52: Reduction in CV death, MI or stroke with ticagrelor
Reduction in CV death, MI or stroke with ticagrelor 13 12 Clopidogrel 11.7 11 Cumulative incidence (%) 10 9.8 9 8 Ticagrelor 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 52 CVGI K-M = Kaplan-Meier; HR = hazard ratio; CI = confidence interval
Slide 53: 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 54: Secondary efficacy endpoints over time
Secondary efficacy endpoints over time Myocardial infarction Cardiovascular death 7 6.9 7 Clopidogrel 6 6 5.8 Clopidogrel 5.1 Cumulative incidence (%) 5 5 Cumulative incidence (%) Ticagrelor 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 55: Total major bleeding
Total major bleeding 13 NS 12 11.6 11.2 11 10 NS Ticagrelor K-M estimated rate (% per year) NS 8.9 8.9 Clopidogrel 9 7.9 8 7.7 7 NS 6 5.8 5.8 5 4 3 2 NS 1 0.3 0.3 0 PLATO major TIMI major Red cell PLATO life- Fatal bleeding bleeding bleeding transfusion* threatening/ fatal bleeding * Proportion of p
Slide 56: Non-CABG and CABG-related major bleeding
Non-CABG and CABG-related major bleeding 9 NS 7.9 Ticagrelor 8 7.4 Clopidogrel 7 NS K-M estimated rate (% per year) 6 5.8 5.3 p=0.026 5 4.5 4 3.8 p=0.025 3 2.8 2.2 2 1 0 Non-CABG Non-CABG CABG CABG PLATO major TIMI major PLATO major TIMI major bleeding bleeding bleeding bleeding 56 CVGI 56
Slide 57: PLATO Conclusions & Therapeutic Implications
PLATO Conclusions & Therapeutic Implications • One year treatment 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 the overall risk o
Slide 58: Diabetes: A growing global problem
Diabetes: A growing global problem Type 2 Diabetes prevalence expected to grow from 285m to 438m by 2030 50-70% of patients are not controlled Diabetes growing rapidly in Europe prevalence is 6.9% U.S. – current prevalence with highest rates (>11%) in rate 10.3% Germany, Austria, Switzerland, and Po
Slide 59: 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 change First Agent Goal* HbA1c A1c=<7 Goal** A1c=<6.5 Normal*** A1c=5% ~30 Years Sources: ADOPT, UKPDS (*) According to the ADA; (**) according to the AACE/ACE;
Slide 60: Dapagliflozin: an exciting new approach to diabetes
Dapagliflozin: an exciting new approach to diabetes Insulin Management Glucose Management • Potential first in class Muscle SGLT2 inhibitor Fat cells Liver Insulin Action - Novel insulin independent TZDs mechanism and site of action Metformin - Potential benefit in overweight and ß cells Kidney obes
Slide 61: Dapagliflozin: comprehensive phase 3 programme
Dapagliflozin: A comprehensive phase 3 programme to define clinical utility T2D treatment Diet and exercise paradigm Oral anti-diabetic Oral anti-diabetic Monotherapy medication plus Insulin alone medication(s) insulin • Monotherapy (study • H2H vs. SU • Add-on insulin +/- OAD clinical studies* 13;
Slide 62: Certriad
Certriad Opportunity • ~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 optio
Slide 63: Certriad target population
Certriad target population • 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 • 8.7MM • Lipid Triad • 12MM CER
Slide 64: Zibotentan: potential new therapy in CRPC
Zibotentan: a potential new therapy in Castration Resistant Prostate Cancer 517,000 ~ 316,00 ~ 165,000 men will develop new cases of will develop CRPC1 metastatic disease1 Prostate cancer 48% asymp. 52% symp2 each year1 James et al. Poster at ECCO/ESMO Sep 2009 James et al. Eur Urol 2009;55:1112–112
Slide 65: Zibotentan ENTHUSE Phase III programme
Zibotentan ENTHUSE Phase III programme covers the full spectrum of CRPC Non Metastatic (M0) Metastatic (M1) Metastatic (M1c) Asymptomatic or Asymptomatic or Symptomatic mildly symptomatic mildly symptomatic for pain for pain 152,000 Patients per year 79,500 Patients per year 85,500 Patients per year
Slide 66: Iressa – personalised healthcare approach for lung cancer
Iressa – A new personalised healthcare approach for lung cancer 1.0 In EGFR mutation-positive patients, Iressa reduces the risk of Probability of Progression free survival progression by 52% vs. doublet chemotherapy 0.8 0.6 Gefitinib EGFR M+ (n=132) Gefitinib EGFR M- (n=91) Carboplatin / paclitaxel
Slide 67: 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 68: Olaparib: potential new therapy for breast and ovarian cancers
Olaparib: a potential new therapy for breast and ovarian cancers Positive Proof of Concept in Breast and Ovarian cancer 100 Best change from baseline (%) 80 60 40 Increasing tumour shrinkage Phase III trial in BRCA Breast gBRCA Breast Cancer 20 Cancer planned with a new 0 Olaparib –20 tablet formula
Slide 69: Vandetanib (Zactima / Zictifa)
Vandetanib (Zactima / Zictifa) NSCLC: - Based on phase 3 results, development in NSCLC terminated. Medullary Thyroid Cancer (MTC) - vandetanib significantly improved progression free survival in patients with medullary thyroid cancer in the ZETA phase 3 trial • Data presented at ASCO 2010 - Regulato
Slide 70: Recentin: status of development programme
Recentin: status of development programme Recentin failed to achieve “non-inferiority” to Avastin CRC in Horizon III AstraZeneca does not intend to file Horizon II met the co-primary endpoint of improving regulatory submissions in 1st line mCRC progression-free survival (PFS) but showed no improveme
Slide 71: OA Pain: Significant Health Issue, High Unmet Need
OA Pain: Significant Health Issue, High Unmet Need Over 151 Million People Suffer From Osteoarthritis Pain1 Low Satisfaction GI Risk Up to 30% of OA patients More than 50% of OA patients on switch or augment therapy in a chronic NSAIDs are at GI Risk4 year, mainly due to efficacy ~1 in 4 OA patients
Slide 72: Vimovo - Proven OA pain relief with built-in gastroprotection
Vimovo - Proven OA pain relief with built-in gastroprotection • 151m OA patients globally, up to 50 % at Demonstrated Significant Risk Reduction in risk of developing NSAID-associated Endoscopic GUs at 6 Months gastric ulcers • Vimovo provides the proven OA pain relief 30% 82% RR 71% RR of naproxen
Slide 73: MDD is a highly prevalent & debilitating disease
MDD is a highly prevalent & debilitating disease with significant levels of unmet need 43 million people worldwide affected by major depressive disorder1 2nd leading cause of disability in ages 15 to 44 2 18 million patients are treated with drugs from a diagnosed population 23million globally 1 44%
Slide 74: TC-5214 Phase 2b Results
TC-5214 Phase 2b Results • Study design: - 270 patients with inadequate response to Citalopram after 8 weeks - Double blind randomisation to placebo or TC-5214 2-8mg • Primary endpoint – difference in change in HAM-D* score at 8 weeks from baseline - 6.0 (95% CI 4.27-7.72), p<0.0001 - Supported by d
Slide 75: TC-5214 clinical development programme
TC-5214 TC-5214 clinical development programmefor development programme patients with inadequate response to SSRIs/SNRIs 2010 2011 2012 2013 2014 Renaissance 2 (Flex) US Renaissance 3 (Flex) MDD Adjunct Renaissance 4 (Fixed) PLANNED SUBMISSION Renaissance 5 (Fixed) Renaissance 7 (LTS) EU Additional
Slide 76: NKTR-118 addresses a significant medical need
NKTR-118 Addresses a significant medical need • Constipation is a common and potentially debilitating adverse effect associated with opioid analgesic use. - 230 million prescriptions for opioid analgesics in US alone in 20071 - Opioid-induced constipation (OIC) can occur in up to 90% of patients tak
Slide 77: NKTR-118 increases spontaneous bowel motions in Phase 2
NKTR-118 significantly increases the frequency of spontaneous bowel motions and reduces time to first SBM in Phase 2 studies Change from Baseline in Spontaneous Median Time (hrs) Bowel Movements (SBMs/week) to First SBM NS P = 0.001 P < 0.002 P = NS P = 0.002 P = 0.0001 60 48.6 Change in SBM (SE) Ti
Slide 78: Fostamatinib disodium: oral approach for Rheumatoid Arthritis
Fostamatinib disodium (FosD): a new oral approach for the treatment of Rheumatoid Arthritis (RA) • RA is a systemic auto-immune inflammatory disease affecting FosD Phase 2 Trial in RA –TASKi1 approx. 1 in 100 people 80 Efficacy Results (12 weeks) Placebo 70 50 mg • FosD is being developed as 60 100
Slide 79: Anti-Infective portfolio covering broad spectrum
Anti-Infective portfolio that covers a broad spectrum of opportunities Spectrum of Activity Resistant Gram+ Gram+ Gram– Resistant Gram– H. influenzae ESBL MRSA S. pneumoniae P. E. coli Producing MDRSP S. aureus aeruginosa K. pneumoniae Gram– Ceftaroline Ceftaroline + NXL104 Ceftazidime + NXL104 79 I
Slide 80: Ceftaroline: late-stage cephalosporin antibiotic
Ceftaroline: A late-stage, next generation cephalosporin antibiotic • Phase III investigational cephalosporin antibiotic in development for treatment of: - Complicated skin and skin-structure infections (cSSSI) - Community-acquired bacterial pneumonia (CAPB) - Demonstrates bactericidal activity agai
Slide 81: cSSSI and community acquired bacterial pneumonia
Complicated skin and skin structure infections (cSSSI) and community acquired bacterial pneumonia (CABP) 81 Infection 81
Slide 82: Robust clinical efficacy in phase 3 trials
Robust clinical efficacy in phase 3 trials • Both cSSSI Phase III studies met primary endpoint (Non-Inferiority vs. vancomycin/aztreonam)1,2 - Active against MRSA • Very robust efficacy results in CABP program - Both cSSSI Phase III studies met primary endpoint (Non-Inferiority vs. ceftriaxone)3,4 1
Slide 83: Anti-RSV Franchise
Anti- RSV Franchise Synagis Motavizumab • Technological advancement over • US BLA for premature and CLD – polyclonal antibody – Respigam Submitted 1Q08 • Standard of care in prevention of • Received CRL from FDA in 4Q08 serious RSV lower respiratory tract infections in high risk infants • Response t
Slide 84: Influenza Vaccines
Influenza Vaccines Novel influenza A (H1N1) vaccine FluMist & LAIV • Order of $453m placed from US • First advance in flu vaccines in 60+ HHS for pandemic years flu vaccine - Highly effective, needle free seasonal flu vaccine • US FDA approved MedImmune’s - For healthy people 2-49 years of H1N1 vacc
Slide 85: Strategy Update & Planning Assumptions 2010+
Strategy Update & Planning Assumptions 2010+ 85 Planning Assumptions
Slide 86: AstraZeneca: A track record of success
AstraZeneca: A track record of success 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 >$1bn
Slide 87: Sales evolution: 1999-2009
Sales evolution: 1999-2009 ($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^ Planning Assumptions 87 87
Slide 88: AZN: Strong financial performance 1999-2009
AZN: Strong financial performance 1999-2009 CAGR 500 Core EPS +16% 450 Core Op Profit +15% 400 350 300 250 Sales +8% 200 150 100 50 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Planning Assumptions 88 Source: AZ annual reports, implied core margins 88
Slide 89: Strong cash generation: 1999-2009
Strong cash generation: 1999-2009 ($bn) 100 90 Reinvestment of 45% of 80 Operating cash flow (excluding major acquisitions) 70 60 50 40 30 20 10 0.5 0.5 0 1999 Pre-R&D After Tax Capex Acquisitions Merck Distributed Other 2009 Net Post Tax R&D* & Payments to Net -10 Funds Disposals Shareholders Funds
Slide 90: Our vision
Our vision AstraZeneca is Focused Integrated Innovation-driven Global OUR VALUES Planning Assumptions 90 90
Slide 91: 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 92: Strategic priorities
Strategic priorities Planning Assumptions 92 92
Slide 93: 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 • Accountability • Drive produ
Slide 94: 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 US healthcare reform - No further “step-change” in evolution of these pressures • Astr
Slide 95: Grow the Business
Grow the Business Strategic Initiatives • Grow market share of key brands that retain exclusivity: Planning assumptions 2010-2014 - Crestor - Seroquel XR • Revenue in the range - Symbicort of $28bn to $34bn per annum over the period • Successfully commercialise recent launches and the next wave • Ri
Slide 96: 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 97: Cash generation & Investment
Cash generation & Investment Reinvest 40 to 50% of Business focus on cash after-tax pre-R&D cash Residual cash flow flow generation flow to drive future available for growth and value • Achieving revenue and • Internal and external • Specific business Core pre-R&D margins R&D needs in planning range
Slide 98: Invest in value-creating innovation
Invest in value-creating innovation Strategic Initiatives Planning assumptions 2010-2014 • Re-prioritisation of target disease areas • 2 NMEs per annum on average • Material efficiency savings in • Reorganisation and process improvement R&D in development • Partial mitigation for rise in • Site cons
Slide 99: 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 Planning Assumptions 99 99
Slide 100: 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 Headcount impact -5,000 -7,000 -9,000 -11,000 -13,000 2006-2009 headcount movements are shown on a Full Time Equivalent basis Planning Assumptions and include AZ employees an
Slide 101: 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: Planning Assumptions balance fro
Slide 102: Key Industry Growth Drivers
Key Industry Growth Drivers 102
Slide 103: Pharmaceutical industry growth drivers
Pharmaceutical industry growth drivers Emergence of expanded populations in new markets Continued unmet medical need Increasing and ageing populations Continued scientific and technological advance 103 103
Slide 104: The global population is ageing
The global population is ageing, with older patients consuming more healthcare than younger patients Global population aged 65 Ratio of healthcare costs of older and older, millions patients relative to 50-64 age group 65-69 70-74 US 977 75-79 80-100 65-69 70-74 Canada 477 75-79 80-100 65-69 70-74 U
Slide 105: 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 $m 80,000 70,000 60,000 2014 50,000 2007 40,000 30,000 20,000 10,000 0 Source: Evaluate Pharma 105 105
Slide 106: Emerging market GDP set for further expansion
Emerging market GDP set for further expansion… G7 countries E7 countries 25,000 Real GDP (US$ billions) 20,000 15,000 10,000 5,000 - 2007 2013-2038 ave. Source: Global Insight Quarterly 106 106
Slide 107: GDP growth drives growth in pharmaceuticals spend
GDP growth drives growth in pharmaceuticals spend United States (off scale) GDP/cap 47,369 Pharma spend Pharma spend/cap 954 per capita US$, 2008 700 France Japan 600 Germany 500 Spain Italy United Kingdom 400 Emerging 300 markets 200 Turkey Brazil 100 Mexico Russian Federation China 0 India 0 10,00
Slide 108: China is investing to improve healthcare coverage and access
Example - China is investing to improve healthcare coverage and access China Population covered increasing … … through 3 schemes ~1,400m 1. UBMI – Urban employees - On average 8% of payroll contributed (~6% by employer) - Up to 400% of annual salary reimbursed according to schedule - $42bn of funds
Slide 109: Emerging markets forecast to contribute ~70% of pharma growth
Emerging markets are forecast to contribute ~70% of pharma growth in the next 5 years Worldwide pharmaceutical sales $130bn $955bn Emerging Markets 70% $55bn Established Markets 30% $765bn 2009E 2014E Emerging markets projected to grow at a 12% CAGR from 2009-2014 1 Emerging markets are all markets
Slide 110: Exploding emerging market middle-class
Exploding emerging market ‘middle-class’ BRIC population with household income above $5,000 +21% p.a. 2004 2009 2014E 270 million 900 million 1,864 million 110 Source: Economist Intelligence Unit, 2010, China NSBA, Indian NFHS, RAND, Brazil PNAD 110
Slide 111: Emerging market opportunity distributed across many markets
The emerging market opportunity is distributed across a large number of markets Emerging market pharma sales, 2009 Brazil, Russia, India, Mexico & Turkey ~$60bn (~33%) ~$90bn Small & (~50%) mid-sized EMs ~$30bn (~17%) China There is a lot more than BRIC-MT 111 Source: IMS 111
Slide 112: Portfolio of markets provides steady, strong growth
While individual markets have ups and downs, the ‘portfolio of markets’ provides steady, strong growth Standard deviation of year-on-year market growth rates, 2003-2009 (%pts) Portfolio of ~20 emerging 2.0 markets South Africa South Korea Saudi Arabia Federation Republic Czech Argentina Mexico Phili
Slide 113: AstraZeneca built a global emerging markets business
AstraZeneca built a truly global emerging markets prescription drug business 2009 Sales1 Asia-Pacific $1.6bn Latin America $1.1bn CEEMEA2 $1.7bn 113 113 1 Actual exchange rate. 2 Central and Eastern Europe, Middle East, and Africa (including Turkey); Source: AZ
Slide 114: AZ fastest growing of top ten pharmacos in BRIC-MT
AZ is the fastest growing of the top ten global pharmacos in BRIC-MT Top 10 MNCs by 2004–09 Rx sales growth in BRIC-MT1 Value growth, CAGR AstraZeneca significantly outgrew the market 23.2% Abbott 20.5% Roche 19.2% Novartis 18.0% Bayer 16.8% Johnson & Johnson 14.8% Sanofi-Aventis 13.7% Pfizer 10.1%
Slide 115: BRIC-MT and small and mid-sized emerging markets contribution to growth
Both BRIC-MT and small and mid-sized emerging markets have contributed significantly to our growth Absolute 2004-09 AZ emerging markets sales by brand1 growth CAGR $4.4bn $2.5bn 18% $3.6bn $2.3bn $1.2bn 16% $1.9bn $1.9bn Small and $1.1bn mid-sized EMs $1.3bn 21% $2.1bn $1.7bn BRIC-MT $0.8bn 2004 200
Slide 116: Brands dominate the market as best proxy for quality
Brands dominate the market as brands are the best proxy for quality Emerging market sales1, 2009, Ex-manufacturer ~$30bn (~17%) ~$180bn ~$50bn (~28%) ~$90bn (~50%) ~$10bn (~5%) Commodity Branded Branded Patented Total generics generics originals originals 1 Across 17 selected markets (China, Turkey,
Slide 117: Highly successful portfolio of brands in emerging markets
Across emerging markets we have a highly successful portfolio of brands AZ product sales in emerging markets, 20091 $513m $464m $335m $298m $286m $282m $275m $254m $210m 1 Actual exchange rates. 2 Includes sales of AZ branded metoprolol succinate (e.g. Seloken ZOK) and metoprolol tartrate (e.g. Selo
Slide 118: Brand lifecycles different than in established markets
Brand lifecycles are fundamentally different than in established markets Despite expiry of key patents in most markets, product growth can be sustained Example: Sales by country, % value growth p.a. Brazil – Diprivan China – Losec Turkey – Pulmicort +10% +29% $24m +16% $146m $18m $15m $16m $91m $11m
Slide 119: Improving profitability across emerging markets
We have delivered improving profitability across emerging markets AZ 2009 pre-R&D emerging markets operating margin (excluding central costs), indexed to 2009 margins in established markets 72% 65% Our current emerging markets margins are similar 55% to our Europe business 5 years ago 2004 2007 2009
Slide 120: Our strategy in emerging markets has three elements
Our strategy in emerging markets has three elements Emerging markets strategy A B C Continue to grow Extending our Broaden portfolio our presence in geographic to selectively the large BRIC-MT foot-print by include branded markets increasing our generics involvement in high-growth small and mid-size
Slide 121: Goal: emerging markets ~25% of AZ sales by 2014
Our goal is to continue double-digit growth, with emerging markets becoming ~25% of AZ sales by 2014 AZ emerging markets revenue goal $12bn $8bn $4bn $0bn 2009 2014 121 121
Slide 122: Patent Litigation & Legal
Patent Litigation & Legal Note: For full litigation disclosures, please refer to the relevant sections of the Company’s 20-F filings and Quarterly Press Releases Legal
Slide 123: Crestor US ANDA patent litigation—'314 patent
Crestor US ANDA patent litigation—’314 patent • July 2010 – Trial court entered judgment that ‘314 substance patent infringed, valid and enforceable - The court ruled Apotex Corp. infringed as an ANDA “submitter” - Court found no inequitable conduct and ‘314 patent to be non-obvious and properly rei
Slide 124: Additional Crestor US ANDA patent litigation—'618 and '152 patents
Additional Crestor US ANDA patent litigation— ’618 and ‘152 patents covering new indications • October 2009--New indication approved for pediatric use of Crestor for heterozygous familial hypercholesterolemia; ‘618 patent already listed in 2007. February 2010—New indication approved for primary prev
Slide 125: Seroquel
Seroquel US patent litigation • Handa, Accord, Biovail and Anchen submitted ANDAs for Seroquel XR challenging listed patents • AstraZeneca has sued entities of all four companies in US District Court, District of NJ for infringement of formulation and compound patents. (Judge Joel Pisano) • Accord a
Slide 126: Nexium US patent litigation
Nexium US patent litigation • Settlement with Ranbaxy announced 15 April 2008 - Ranbaxy granted license to launch 27th May 2014 - Ranbaxy holds 180 days exclusivity (“first to file”) • Settlement with Teva/IVAX January 2010 - Teva granted license to launch 27th May 2014 • Both Ranbaxy and Teva conce
Slide 127: Pulmicort Respules US patent litigation
Pulmicort Respules US patent litigation • Teva - 19 Nov 08: FDA approval of generic Pulmicort Respules. Teva launched at risk. AZ Citizen Petition denied - 26 Nov 08: AZ settled with Teva - Exclusive license beginning 15 Dec 09 - Teva launched on that date - AZ receiving royalty on sales of Teva’s p
Slide 128: Newsflow 2010
Newsflow 2010
Slide 129: 2H 2010 Newsflow
2H 2010 Newsflow Jul Aug Sep Oct Nov Dec Brilinta FDA response on NDA 16 Sep Ceftaroline PDUFA 27/8 EU Submission Dapagliflozin Phase III data (EASD) EASD Global submissions Faslodex 500mg US regulatory response Approved Motavizumab FDA Response on CRL response 2nd CRL ONGLYZA ONGLYZA-metformin FDC
Slide 130: Investor Relations Contacts
Investor Relations Contacts
Slide 131: Investor Relations Contacts
Investor Relations Contacts Investor Enquiries London: Jonathan Hunt [email protected] +44 207 604 8122 mob: +44 7775 704032 Karl Hård [email protected] +44 207 604 8123 mob: +44 7789 654364 Clive Morris [email protected] +44 207 604 8124 mob: +44 7710 031012 Investo
Slide 132: 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