AstraZeneca PLC · LSE:AZN
AstraZeneca — H1 2008 Earnings Presentation
96 slides from AstraZeneca's earnings presentation, August 2008
Slide 1: General presentation 2Q & HY 2008 Results
General presentation 2Q & HY 2008 Results
Slide 2: About AstraZeneca
About AstraZeneca World leading products in 6 disease areas: cardiovascular, inflammation & respiratory; oncology; neuroscience; infection; gastro-intestinal 11 drugs with annual sales >$1bn (MAT 2Q 08) Over 66,000 employees worldwide Around 13,000 people dedicated to discovering and develop
Slide 3: AstraZeneca strategic priorities
AstraZeneca strategic priorities “MAKING THE MOST MEANINGFUL DIFFERENCE TO PATIENT HEALTH THROUGH GREAT MEDICINES” Reshape Change our Strengthen Grow behaviour the the and our the pipeline business business culture OUR VALUES 3
Slide 4: 2Q & HY 2008 Results
Astrazeneca? 2Q & HY 2008 Results —
Slide 5: Achievements 1H 2008
Achievements 1H 2008 Grow Grow Earnings per share target increased to $4.60 to $4.90 the the Emerging Markets +20% to over $1 bn in Q2 business business Successful mitigation of Nexium and Seroquel patent risks Productivity Culture and Restructuring and Synergy Programmes Reshape on track th
Slide 6: Headline results 1H 2008
Headline results 1H 2008 2008 2007 Actual CER $m $m growth growth Sales 15,633 14,239 +10% +3% Core Operating Profit 5,502 4,683 +17% +7% Net Finance Inc/(Exp) (308) 115 Core Profit Before Tax 5,194 4,798 +8% -2% Core EPS $2.53 $2.24 +13% +3% Reported EPS $2.14 $1.97 +9% -3% Interim Dividend $0.55 $
Slide 7: Headline results 2Q 2008
Headline results 2Q 2008 2008 2007 Actual CER $m $m growth growth Sales 7,956 7,273 +9% +2% Core Operating Profit 2,737 2,409 +14% +3% Net Finance Inc/(Exp) (194) 18 Core Profit Before Tax 2,543 2,427 +5% -6% Core EPS $1.25 $1.17 +7% -4% Reported EPS $1.11 $0.95 +17% +4% 7
Slide 8: Regional sales performance 2Q 2008
Regional sales performance 2Q 2008 2008 CER $m growth Sales 7,956 +2% North America 3,463 -3% US 3,126 -4% excluding Toprol-XL 3,055 +4% ROW Established Markets 3,340 +2% Western Europe 2,606 +1% Japan 518 +10% Other Established 216 +7% ROW Emerging Markets 1,153 +20% 8
Slide 9: Key Brands
Astrazeneca? Key Brands — ~~
Slide 10: Key brand summary: 2Q 2008
Key brand summary: 2Q 2008 2008 2007 CER $m $m growth Nexium 1,323 1,312 -4% Seroquel 1,112 963 +11% Crestor 916 678 +27% Arimidex 490 430 +6% Symbicort 518 414 +12% Total 4,359 3,797 +8% 10
Slide 11: Nexium
Nexium 2Q 2008 Sales: $1,323m -4% US 1400 Volume +11% Growth in non-retail channels 1200 Retail units +0.4%* ROW 1000 $569m +11% Negative price variance 800 ROW 600 US Emerging Markets +36% 400 $754m -12% 200 0 2Q 2007 2Q 2008 US ROW * Source: IMS Health, US NPA June 2008 11
Slide 12: Crestor
Crestor 2Q 2008 Sales: $916m +27% US Only branded statin to gain share 1000 US TRx +8%* Gains in new starts and switches 800 ROW ROW $501m +37% Western Europe +19% 600 Canada +30% Japan +150% 400 Dynamic share: 24%** US 200 $415m +18% 0 2Q 2007 2Q 2008 US ROW * Source: IMS Health,
Slide 13: Crestor: Only brand to gain TRx share
Crestor: Only brand to gain TRx share US TRx Share Change* Dec Jun vs Dec Crestor 8.62% 9.13% 0.51% Vytorin 12.38% 8.62% -3.76% Lipitor 32.83% 30.74% -2.09% Generics 44.45% 49.94% 5.49% Other 1.72% 1.57% -0.15% * Source: IMS Health, US NPA June 2008 13
Slide 14: 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 15: Crestor: unique atherosclerosis indication
Crestor: unique atherosclerosis indication METEOR primary endpoint: Rate of change of maximum IMT Atherosclerosis indication and at 12 carotid sites Rosuvastatin vs placebo labelling achieved in US and Europe respectively Change in maximum IMT of 12 carotid sites (mm) Further METEOR atherosclero
Slide 16: Crestor – Proven to slow the progression of atherosclerosis
Crestor – Proven to slow the progression of atherosclerosis Key Studies METEOR ASTEROID ORION Label indication Approved in US Nov 2007 ‘Proven to slow the progression of atherosclerosis’ 16
Slide 17: Crestor announcement print ad
oem GOOD rint Nas FOR ©0000 YOUR ARTERIES. CRESTOR is now proven to slow the buildup of plaque in the arteries of adults with high cholesterol. S@eeoo plaque in your arteries is ale If you have high cholesterol you may be at risk for a progressive disease i called atherosclerosis, the buildup of pla
Slide 18: 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% redu
Slide 19: 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 20: JUPITER outcomes study: timelines
JUPITER outcomes study: timelines Stopped early based on a recommendation from an Independent Data Monitoring Board and Steering Committee (March 29, 2008) Unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo
Slide 21: Statins, Fibrates & CAIs
Statins, Fibrates & CAIs Statins Liver Inhibit HMG-CoA reductase Dietary cholesterol (cholesterol Cholesterol in bile synthesis) in the liver Promotes clearance of circulating LDL-C Lower LDL-C X Fibrates CAIs Stimulate PPARa in Inhibit (re)absorption the liver of cholesterol from Increa
Slide 22: Crestor/TriLipix (ABT-335)
Crestor/TriLipix (ABT-335) Key Development Components 2 Pivotal Safety/Efficacy Studies 1 Long-Term Safety Study 2 Drug Interaction Studies Appropriate PK Formulation Studies 1 PK Study in Special Population Progressed to Phase III Aug 07 Free combination data presented by Abbott at
Slide 23: Seroquel
Seroquel 2Q 2008 Sales: $1,112m +11% US TRx’s +6%* 1200 Market TRx’s +3% Market leading TRx share 1000 31.6% ROW Seroquel XR ~40% of $379m +18% 800 Rx growth 600 Seroquel XR LCM launches in US late 2008 to 2009 400 $733m +8% Bipolar mania and depression Major Depressive Disorder 200
Slide 24: LCM update: Seroquel
LCM update Seroquel Regulatory update: Filed Approval US IR Bipolar Depression IR Bipolar Maintenance XR Schizophrenia XR Bipolar Mania 4Q 2008 XR Bipolar Depression 4Q 2008 XR Bipolar Maintenance On track 4Q 2008 3Q 2009 XR Major Depressive Disorder 4Q 2008 XR Generalised Anxiety Disorder 1Q 2009 E
Slide 25: Seroquel XR: Positive MDD & GAD data
Seroquel XR: Positive MDD & GAD data SEROQUEL XR™ Monotherapy reduced patients’ depression symptoms MDD & GAD programme: Study 2: Baseline Week 1 Week 2 Week 4 Week 6 7,000 patients change in Mean 0 MADRS total Placebo (n=152) 3 studies presented in ‘07 score from Quetiapine XR 150 mg/day (n=147
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 150mg2 400mg3 600mg3 Patient nc nc le va le le population va va e pr e e pr
Slide 27: Symbicort
Symbicort 2Q 2008 Sales: $518m +12% ROW Emerging Markets +29% 550 500 US 450 ROW Specialist trial: ~80% 400 $461m +6% 27% share of new starts 350 Primary Care trial: 33% 300 1 in 6 new starts 250 Overall market (w/e 18 July) 200 NRx share 9.1%* 150 New start share 17.6%** 100 50
Slide 28: Symbicort US COPD & paeds filed
Symbicort US COPD & paeds filed SUN COPD Pivotal Trial US Pre-dose FeV1 Results COPD sNDA filed April 08 LSMean Change FEV1 (L) 2 large pivotal clinical trials, SUN and SHINE, met co- primary endpoints Paediatrics (6-11yrs) sNDA filed June 08 Actuation counter on track to launch in 2H
Slide 29: Arimidex
Arimidex 2Q 2008 Sales: $490m +6% US TRx’s +1%* Market flat 600 Market leading TRx share 38.2% 500 Patients begin to reach end of 5-yr treatment term 400 ROW $289m +1% 300 200 US 100 $201m +13% 0 2Q 2007 2Q 2008 US ROW * Source: IMS Health, US NPA June 2008 29
Slide 30: AstraZeneca
Astrazeneca?
Slide 31: Delivering on our promise
Delivering on our promise Differentiated 1H 2008 achievements; & Targeted Life Cycle Management delivered – 12 submissions Medicines Two NCE submissions Ongoing productivity improvements Faster cycle times Leaner and cost efficient organisation Stronger pipeline – 12 projects in Phase II
Slide 32: Faster, leaner, stronger
Faster, leaner, stronger Low to mid single digit R&D cost increase Quality Faster cycle times Consolidating our drive to 8 year cycle time PERFORMANCE Cost efficiency Cost Speed Significant cost reduction in early portfolio vs 2006 Phase I median cycle time 25 2010 target 20 months 15 10 5
Slide 33: Stronger pipeline July 2008
Stronger pipeline 31 July 2008 New Filing Progression Addition MEDI-528 Motavizumab No Change ONGLYZA™ EBV vaccine* IPI-504 Pneumococcal (saxagliptin) / AZD7762 vaccine* CytoFab (MEDI-561) Metformin FDC Motavizumab AZD7325 MEDI-564* AZD9056 MEDI-538* Seroquel XR ONGLYZA™ Symbicort AZD6280 MEDI-563 A
Slide 34: Delivering on our promise: pipeline balance
Delivering on our promise Achieving steady state 143 required to deliver targets 137 24 23 12 Phase III projects 120 12 91 106 25 10 Strengthening Phase II 20 30 25 25 Clinical 5 Strong balance of: 5 6 18 13 13 41 35 Biologics vs small 23 17 17 molecules 31 45 42 43 Pre- FIC vs BIC 49 Cl
Slide 35: Discovery productivity continues to grow
Discovery productivity continues to grow More candidates entering development More reaching FTIMs 39 36 27 33 8 24 30 3 27 21 24 18 21 15 18 15 28 12 21 12 22 9 9 15 17 12 14 6 10 6 8 9 8 6 3 3 0 0 2002 2003 2004 2005 2006 2007 2002 2003 2004 2005 2006 2007 Small Molecules Biologicals Small Molecule
Slide 36: Phase III portfolio
Phase III portfolio Pre- Clinical Phase I Phase II Phase III portfolio LCM PN400 ONGLYZA™ Crestor/ TriLipix Zactima MEDI-561 (IPI-504) Recentin AZD0837 Recentin AZD6140 Dapagliflozin ZD4054 Motavizumab 36
Slide 37: ONGLYZA (saxagliptin)
ONGLYZA™ (saxagliptin) Delivered NDA submission Jun 08 and EU MAA Jul 08 (15 months early) Completed Phase III – robust data package of 6 positive trials >3,000 exposed to ONGLYZA™ in Phase III for up to 2 years >4,000 exposed in programme New data presented at ADA Jun 08 showing significa
Slide 38: ONGLYZA Phase III data
ONGLYZA™ Phase III data ONGLYZA™ Add-On to metformin: Significant HbA1c reductions from baseline Significant reductions in HbA1c, FPG, PPG from baseline at week 24 38
Slide 39: Zactima
Zactima All four phase III studies completed recruitment on schedule: ZEST (monotherapy vs erlotinib), ZODIAC (docetaxel combination), ZEAL (pemetrexed combination), ZETA (thyroid) License applications driven by event rates - event rates slowed in three studies NSCLC and thyroid parallel sub
Slide 40: Zactima filings 1H 09
Zactima filings 1H 09 2nd line NSCLC and Thyroid submissions to be filed in 1H09 Good progress with development programme; > 3500 patients recruited NSCLC ZEST (Study 57) – monotherapy vs erlotinib Recruitment ZODIAC (Study 32) – combination with docetaxel vs docetaxel complete ZEAL (Study
Slide 41: Recentin
Recentin Phase III progression in 1st line CRC announced Feb 08 – on track EU and US submissions in CRC and rGBM planned for 2010 Encouraging new data in rGBM, renal, prostate and ovarian cancers Re-evaluating NSCLC strategy – Phase II/III BR24 study data presentation by year end 41
Slide 42: Recentin: CRC and glioblastoma
Recentin: CRC and glioblastoma 1st line NSCLC PhII/III / -RECENTIN TM +/-RECENTIN CRC H2H with Avastin HORIZON III : 1st line CRC PhIII FF+Avastin vs FF+RECENTIN 20mg 1st 1stline line PhIII NSCLC gem/cis cis+/ +/ -RECENTIN HORIZON2nd I : line 2nd CRC line CRC PhII PhII FF+bevacizumab vs FF+RECENTINT
Slide 43: AZD6140: PLATO recruitment complete
AZD6140: PLATO recruitment complete PLATO study recruitment complete and patient follow-up initiated Approximately 18,600 patients enrolled in total EU and US submissions planned 2H 2009 No significant safety concerns identified Phase II bleeding similar to Plavix (clopidogrel) Reversibi
Slide 44: PLATO study design
PLATO study design 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 If pretreated, no additional loading dose; 180-mg loading dose, then if naïve, standard 300-mg loading dose,
Slide 45: 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 Mean % Inhibition 80 60 60 40 40 20 20 2 4 8 12 2 4 8 12 24 2 4 8 12 2 4 8 12 24 Time, h Time, h Husted SE et al. Eur Heart J 2006;27:1038
Slide 46: 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 47: 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 48: AZD0837: clinical experience
AZD0837 Clinical experience >900 AF patients exposed Longest exposure to date 16 months Study-7 (IR): 249 AF patients for 3 months Study-8: 955 AF patients, 3-9 months treatment Study-42: Long-term safety study, 523 AF patients randomised from study-8, longest exposure 16 months Study-51
Slide 49: AZD0837: opportunity
AZD0837 Opportunity Predictable relationship between dose and blood levels Low to moderate PK variability Dose selected via biomarkers and extensive modelling, guided by Exanta experience ER formulation Once daily without ‘peaks and troughs’ No relevant food interactions Low to moderat
Slide 50: Dapagliflozin – exciting new approach to diabetes
Dapagliflozin – 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 Metformin mechanism and site of action ß cells Kidney Potential benefit in overweight Pancreas Ins
Slide 51: Dapagliflozin
Dapagliflozin Potential ‘First in Class’ SGLT2 to meet need in diabetes market 7 Phase III studies ongoing Phase IIb data presented at ADA 08 US and EU submissions 2010 Dapagliflozin Increases Dapagliflozin Reduces FSG Urinary Glucose Excretion 120 Dapagliflozin Dose Placebo 5 mg 25 mg 100 m
Slide 52: ZD4054: new approach to prostate cancer
ZD4054: new approach to prostate cancer ZD4054 Phase II Overall Survival Results Potential ‘First in Class’ in Hormone Resistant Prostate Cancer (M1) Endothelin A Antagonist in HRPC Promising survival data in Proportion of patients alive M1 stage prostate cancer ZD4054 10 mg Generally well tol
Slide 53: 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 54: PN400: naproxen + esomeprazole
PN400: naproxen + esomeprazole Under evaluation for the chronic treatment of the signs and symptoms of arthritis in patients at risk for NSAID associated ulcers PN200-301 Proof of Concept final study results presented at DDW – 5/08 Phase III registration program fully enrolled On track for U
Slide 55: LCM update: Iressa INTEREST
LCM update Iressa MAA submitted for 2nd line adv NSCLC May 08 INTEREST study 1.0 Iressa docetaxel N 723 710 0.8 Events 593 (82.0%) 576 (81.1%) Primary Cox analysis without covariates HR (96% CI) = 1.020 (0.905, 1.150) 0.6 Conclude non-inferiority Probability in the overall per protocol (PP) popula
Slide 56: LCM update: Iressa IPASS
LCM update Iressa IPASS (Iressa Pan-Asia Study): Iressa vs carboplatin/paclitaxel in 1st line adv NSCLC 1,217 patients from Asia (adenocarcinoma histology and never smokers or long-term light ex-smokers) Superior Progression Free Survival and Response Rate with Iressa relative to carboplatin/p
Slide 57: Disease area strategy
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 Chronic
Slide 58: Externalisation is much more than in-licensing
“Externalisation” is much more than “in-licensing” Albireo is evidence of our commitment to pursue innovative options to realise value for patients and shareholders Spinout strategically dovetails with our disease area focus (GI) Progresses compounds which AZ would not have advanced internally
Slide 59: Further progression of Disease Area Strategy in 2008
Further progression of Disease Area Strategy in 2008 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 therap
Slide 60: AstraZeneca R&D Fit for the Future
AstraZeneca R&D Fit for the Future 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 p.a. to market on average 9 On track 60
Slide 61: Biologics & MedImmune
Astrazeneca? Biologics & MedImmune —— Ere
Slide 62: A strategic necessity against a changing industry science base
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 13% 400 50 Monoclonal 12% 2
Slide 63: Biologics business characteristics
Biologics business characteristics Rapidly growing markets 13% CAGR 2007-20101 Longer product life cycles Lower exposure to generic competition; high unmet need Higher probabilities of success Higher success rates in clinical development2 Higher/more complex COGS Lower/more targeted
Slide 64: MEDI completes AstraZeneca's core science base
MEDI completes AstraZeneca’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 VEGF-A AstraZeneca x VEGF-A VEGF-B VEGF-C VEGF-D VEGF-C PlGF V
Slide 65: 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 66: 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: U.S. ’98, EU ’00, JP ’02 Marketed by MedI
Slide 67: Reported WW sales of Synagis
Reported WW sales of Synagis® RSV Seasonal Basis ($million) $1,400 $1,123 $1,200 $1,056 7% $992 5% 12% $885 $1,000 12% $788 30% $800 $606 26% $482 $600 34% $400 00/01A 01/02A 02/03A 03/04A 04/05A 05/06A 06/07A Reported U.S. sales Reported ex-U.S. sales 67
Slide 68: Synagis U.S. Patient Segment Penetration
Synagis® U.S. Patient Segment Penetration Second CLD & Season CHD estimated 90% 32-35 70% Wk GA 85% 22% <32 Wk GA Segment Est. Total Size 06/07 32-35 Wk GA ~248,000 333k <32 Wk GA ~85,000 CHD & CLD 21,000 – 30,000 2nd season ~18,000 >36 Wk GA (TERM) ~3,900,000 Patient portion penetrated 68
Slide 69: Synagis: Evolution of COID guidelines
Synagis®: Evolution of COID1 guidelines Group 1998 2003 2006 <32s During their first RSV season … … <6 months of age and two of the <6 months of age and any risk factors following RFs: child care attendance, school-aged siblings, exposure to Same, but tobacco “has not been including: school age sibl
Slide 70: 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 71: MedImmune / Biologics R&D
MedImmune / Biologics R&D Motavizumab: next evolution in RSV prevention (beyond Synagis®) via increased potency, improved efficacy Premature and CLD PDUFA Nov 29, 2008 Completed enrollment 2nd season of CHD study and 4th season of Native American study Initiate RSV long term consequences tri
Slide 72: MedImmune / Biologics R&D (cont'd)
MedImmune / Biologics R&D (cont’d) MT103/MEDI-538 – bispecific T-cell engager targeting CD19 Phase I underway in Europe Phase II studies in Europe and U.S. in B-cell lymphoma MEDI-528 – anti-IL9 MAb Four Phase IIa trials ongoing in asthmatics Phase 2 efficacy data expected 2008 CAT-354
Slide 73: MedImmune / Biologics R&D (cont'd)
MedImmune / Biologics R&D (cont’d) CAT-8015 – anti-CD22 immunotoxin fusion protein Phase I/II dose escalation leukemia and lymphoma studies Phase II go/no-go 2009 MEDI-563 – anti-IL5 receptor MAb Proof of mechanism established in Phase I trial Phase IIa planned 1Q09 CAM-3001 – anti-GM-
Slide 74: Key developments: Motavizumab
Key developments Motavizumab US BLA as RSV prophylaxis for premature infants and infants with CLD submitted Jan 08 – FDA review ongoing CHD study analysis ongoing – US sBLA submission 1H 2009 EU submission for all high risk infants 1H 2009 Phase III Native American study accrual complete 74
Slide 75: 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 Drive value from CAT and Abgenix investments Bring biologics commercial expertise to AstraZeneca Expand external strategic o
Slide 76: MedImmune: fully integrated biopharmaceutical company
MedImmune Establishes AZ as a fully integrated biopharmaceutical company Operating model in place; new R&D governance body strategically aligned with overall AZ R&D objectives Synergies secured $450m by 2009 >$500m by 2010 Cash accretive in 2009 Long term synergies come from: Small mol
Slide 77: AZ R&D/MedImmune
AZ R&D/MedImmune Strategically aligned, operationally independent R&D Executive Market Committee Market Biologics Small Molecules Aligned TA strategy Product Product Development Development CDs Biologicals CDs Small Molecules Combined small & large molecule target identification & Discovery collabor
Slide 78: Patents
Astrazeneca? — ee
Slide 79: Hatch Waxman Patent Act (1984)
Hatch Waxman Patent Act (1984) *1984 Hatch Waxman: Patent Term Restoration Act ANDA process for Patent reform generic drug approval 3 Year Patent 180 Day Exclusivity Period Reformulation ANDA NDA of an approved drug with Generic manufacturers Formulation / Laboratory & animal clinical trials may fil
Slide 80: 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”) Other challengers – Teva, Dr Reddy’s Expiry of 30 months st
Slide 81: Seroquel US patent litigation
Seroquel™ US patent litigation First to File – Teva Judge granted AZ’s Summary Judgement of No Inequitable Conduct on July 1, 2008 ending case Trial no longer necessary Sandoz and Teva have filed notices of appeal AZ will oppose the defendants’ appeals and vigorously defend its patent cove
Slide 82: 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 Fa
Slide 83: Pulmicort Respules US patent litigation
Pulmicort Respules™ US patent litigation IVAX (now TEVA) notified AZ of an ANDA in Sep 2005 AZ filed suit Oct 2005 US Patents 6598603 and 6899099 expire Dec 2018 with paediatric exclusivity until June 2019 June 2006 AZ filed a Citizen’s Petition with the FDA June 2008 IVAX filed motion for
Slide 84: Financials
Astrazeneca? mlatclarersits C—O
Slide 85: Guidance for FY 2008
Guidance for FY 2008 Core EPS Range of $4.60 to $4.90, +$0.15 Sales Low to mid-single digits (CER) Core Gross Margin Maintain at 2007 level (CER) Core R&D Low to mid-single digits (CER) Core SG&A Low single digits (CER) Core Other Income Approx 2007 levels 85
Slide 86: Basis for 2008 guidance
Basis for 2008 guidance Combined results of AstraZeneca and MedImmune Core EPS Intangibles at 2007 levels Tax rate around 29.5% Currency: 4Q07 rates £ = $2.04 € = $1.45 SEK = 6.42/$ 86
Slide 87: Core margin: 2Q 2008
Core margin: 2Q 2008 CER Delta vs PY $m growth % sales CER Core Gross Margin 6,525 +4% 82.0 +170 bps Distribution (75) +14% 0.9 -10 bps Core R&D (1,265) 0% 15.9 +30 bps Core SG&A (2,656) +5% 33.4 -90 bps Core Other Income 208 -19% 2.6 -70 bps Operating Profit 2,737 +3% 34.4 +30 bps 87
Slide 88: Core margin: 1H 2008
Core margin: 1H 2008 CER Delta vs PY $m growth % sales CER Core Gross Margin 12,732 +5% 81.5 +120 bps Distribution (141) +8% 0.9 - Core R&D (2,447) -1% 15.7 +70 bps Core SG&A (5,001) +3% 32.0 -10 bps Core Other Income 359 -10% 2.3 -40 bps Operating Profit 5,502 +7% 35.2 +140 bps 88
Slide 89: Cash generation: first half 2008
Cash generation: first half 2008 2008 2007 $m $m Opening net cash/(debt) (9,112) 6,537 Net cash from operating activities 4,292 3,184 Merck (2,630) - Net Acquisitions (incl. MedImmune) - (14,543) Other capital expenditure (593) (728) Dividends/Net share buy-back (2,180) (3,910) Other movements (136)
Slide 90: Productivity & synergy initiatives delivering
Productivity & synergy initiatives delivering All programmes progressing to plan Restructuring programme announced in 2007 Total cost $1.6bn; annual benefit $900m from 2010 MedImmune synergy programme Total cost $375m; annual benefit $500m from 2010 2007 progress Costs of $966m charged
Slide 91: Capital structure: 30 June 2008
Capital structure: 30 June 2008 30 Jun 07 1 Jan 08 31 Mar 08 30 Jun 08 $m $m $m $m Debt (1,384) (10,876) (11,116) (11,032) Short term borrowings (14,015) (4,280) (3,886) (3,841) Cash 5,311 6,044 3,250 4,514 Net Cash / (Debt) (10,088) (9,112) (11,752) (10,359) Strong investment grade rating retaine
Slide 92: 2008 performance priorities
2008 performance priorities Continue to drive top line growth Life cycle management Sales Force Effectiveness Emerging markets Progress productivity initiatives and restructuring Increased focus on cash management Continued investment in R&D 92
Slide 93: Distribution policy
Distribution policy Dividends First interim dividend in 2008 $0.55 Policy: To grow in line with reported earnings (pre restructuring costs) maintaining at least 2x dividend cover Share repurchases Reflective of stated financial priorities In the region of $1bn in 2008, subject to busines
Slide 94: 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 Earnings Euro 2.6% 7.3% Sterling 0.4% -4.6% Swedish Krona 0.1% -4.4% Other currencies 2.2% 4.3% 94
Slide 95: 2H 2008 newsflow
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