AstraZeneca PLC · LSE:AZN
AstraZeneca — FY2008 Earnings Presentation
70 slides from AstraZeneca's earnings presentation, 2009
Slide 1: 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
Slide 2: Annual Results 2008
Ast azeneca Annual Results 2008
Slide 3: David Brennan, CEO
David Brennan CEO
Slide 4: Strategic priorities
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 AstraZeneca Annual Results 2008
Slide 5: Headline results FY08
Headline results FY08 2008 2007 Actual CER $m $m growth growth Sales 31,601 29,559 +7% +3% AstraZeneca Annual Results 2008
Slide 6: Sales highlights
Sales highlights Key brands drive outperformance in the US Strong growth in emerging markets AstraZeneca Annual Results 2008
Slide 7: Strong growth in emerging markets
Strong growth in emerging markets 2008 Sales 2008 CER Sales Growth 60 $557m 50 +2% +2% 40 % $14,785m $12,543m 30 $237m $235m 20 +16% 23% 23% 54% 10 $4,273m 0 North America Established RoW Emerging Markets AstraZeneca Annual Results 2008
Slide 8: Strong positioning in emerging markets
Strong positioning in emerging markets IMS Ranking Latin America Asia Pacific CEEMEA Q3 2008 YTD Growth Q3 2008 YTD Growth Q3 2008 YTD Growth Market 12.5% Market 16.1% Market 12.5% 1. AstraZeneca 20.8% 1. AstraZeneca 19.2% 1. Roche 16.7% 2. EMS 15.6% 2. Novartis 17.2% 2. Pfizer 14.4% 3. Novartis 15.
Slide 9: Sales highlights
Sales highlights Key brands drive outperformance in the US Strong growth in emerging markets Successful mitigation of patent risks Nexium Seroquel Pulmicort Respules AstraZeneca Annual Results 2008
Slide 10: Headline results FY08
Headline results FY08 2008 2007 Actual CER $m $m growth growth Sales 31,601 29,559 +7% +3% Core Operating Profit 10,958 9,411 +16% +9% Core EPS $5.10 $4.38 +16% +8% Reported EPS $4.20 $3.74 +12% +2% Dividends $2.05 $1.87 +10% Net Share Repurchase $451 $3,952 AstraZeneca Annual Results 2008
Slide 11: Strengthening the pipeline
Strengthening the pipeline Clinical projects increased by 60% 137 144 Phase III/Registration doubled 23 24 106 120 10 Phase II portfolio increased by 91 10 25 >50% in 2008 25 25 20 31 5 Clinical 5 6 18 Up to 4 new product filings 13 13 41 34 planned for 2009 17 17 23 31 45 42 46 Pre- 49 clin
Slide 12: Annual Results 2008
Ast azeneca Annual Results 2008
Slide 13: Simon Lowth, Chief Financial Officer
Simon Lowth Chief Financial Officer
Slide 14: Headline results FY08
Headline results FY08 2008 2007 Actual CER $m $m growth growth Sales 31,601 29,559 +7% +3% Core Operating Margin 34.7% 31.8% +290 bps +160 bps AstraZeneca Annual Results 2008
Slide 15: Headline results FY08
Headline results FY08 2008 2007 Actual CER $m $m growth growth Sales 31,601 29,559 +7% +3% Core Operating Profit 10,958 9,411 +16% +9% Net Finance Expense (463) (111) Core EPS $5.10 $4.38 +16% +8% Restructuring/Synergy ($0.43) ($0.46) MedImmune amortisation ($0.21) ($0.12) Ethyol and other impairmen
Slide 16: Regional sales performance FY08
Regional sales performance FY08 2008 CER $m growth Sales 31,601 +3% North America 14,785 +2% US 13,510 +1% ROW Established Markets 12,543 +2% Western Europe 9,743 +1% Japan 1,957 +4% Other Established 843 +15% ROW Emerging Markets 4,273 +16% AstraZeneca Annual Results 2008
Slide 17: Sales summary: FY08
Sales summary: FY08 2008 CER CER $m % $m Nexium 5,200 -2 (121) Seroquel 4,452 +9 346 Crestor 3,597 +26 714 Arimidex 1,857 +4 69 Symbicort 2,004 +22 346 Total Key Brands 17,110 +9 1,354 AstraZeneca Annual Results 2008
Slide 18: Nexium
Nexium FY 08 Sales: $5,200m -2% US Dispensed retail tablet volume up 2%* 6000 Only major PPI brand to grow volume* 5000 Price variance normalised Q408 ROW FY08 average prices down 11% 4000 $2,099m +9% RoW 3000 Emerging markets +26% Western Europe +2% 2000 US Reference pricing in Ge
Slide 19: Seroquel
Seroquel FY 08 Sales: $4,452m +9% US Seroquel TRx’s +6.5%* 5000 Market TRx’s +5% Market leading TRx share 31.6% 4000 ROW $1,437m +17% Seroquel XR: 37% of Rx gowth 3000 RoW Value & volume growth ahead of market 2000 US Seroquel XR LCM launches planned $3,015m +5% for 2009 1000 Bipol
Slide 20: Crestor
Crestor FY 08 Sales: $3,597m +26% US Crestor TRx’s +10.8%* 4000 Market TRx’s +4.4% Crestor TRx share 9.9% Dec 08 3000 New patient share 12.5% end Dec 08 ROW $1,919m +34% Positive net switches from other statins 2000 US 1000 $1,678m +18% 0 FY 07 FY 08 US ROW * Note: This information is an
Slide 21: Crestor: Only brand to gain TRx share
Crestor : Only brand to gain TRx share TRx Share Change Dec 07 Dec 08 Change Crestor 8.6% 9.9% 1.25% Vytorin 12.4% 6.9% -5.46% Lipitor 32.8% 28.5% -4.29% Generics 44.5% 53.1% 8.69% Other 1.7% 1.5% -0.20% * Note: This information is an estimate derived from the use of information under license from I
Slide 22: Crestor
Crestor FY 08 Sales: $3,597m +26% US Crestor TRx’s +10.8%* 4000 Market TRx’s +4.4% Crestor TRx share 9.9% Dec 08 New patient share 12.5% end Dec 08 3000 ROW Positive net switches from other statins $1,919m +34% RoW 2000 Western Europe +16% Canada +30% US 1000 $1,678m +18% Japan +
Slide 23: Arimidex
Arimidex FY 08 Sales: $1,857m +4% Q4 sales -1% Maturing class 2000 Tamoxifen share stabilising Patients begin to reach end of 5 year treatment term ROW $1,103m +1% 1000 US $754m +9% 0 FY 07 FY 08 US ROW AstraZeneca Annual Results 2008
Slide 24: Symbicort
Symbicort FY 08 Sales: $2,004m +22% US Specialist trial rate ~90% 2000 >30% share of new starts** Primary care trial: >50% >17% share of new starts** Overall market (w/e 16 Jan) NRx share 11.7%* ROW $1,749m +9% New start share 18.3%** 1000 RoW Western Europe +6% Emerging Market
Slide 25: Pulmicort
Pulmicort FY 08 Sales: $1,495m 0% US Pulmicort Respules ~90% of total sales 2000 Q408 Pulmicort Respules -18% Settlement with TEVA 26 November ROW “At Risk” shipments remains in market $513m -2% Generic share of TRx 15% in Q408 1000 Generic share: 40% in Dec 08 US $982m +2% 0 FY 07 F
Slide 26: Sales summary: FY08
Sales summary: FY08 2008 CER CER $m % $m Nexium 5,200 -2 (121) Seroquel 4,452 +9 346 Crestor 3,597 +26 714 Arimidex 1,857 +4 69 Symbicort 2,004 +22 346 Total Key Brands 17,110 +9 1,354 AstraZeneca Annual Results 2008
Slide 27: Sales summary: FY08
Sales summary: FY08 2008 CER CER $m % $m Total Key Brands 17,110 +9 1,354 MedImmune Products 1,362 n/m 648 Toprol-XL/Seloken 807 -46 (667) Casodex 1,258 -12 (161) Losec 1,055 -14 (156) Pulmicort 1,495 - 7 All others 8,514 - 4 Total Sales 31,601 +3 1,029 AstraZeneca Annual Results 2008
Slide 28: Core margin: FY08
Core margin: FY08 Delta vs PY $m CER% % sales CER% Gross Margin 25,408 +4 80.4 +80 bps Distribution (291) +16 0.9 -10 bps R&D (4,953) -1 15.7 +80 bps SG&A (9,940) +3 31.4 +10 bps Other Income 734 +3 2.3 _ Core Operating Profit 10,958 +9 34.7 +160 bps AstraZeneca Annual Results 2008
Slide 29: Restructuring and synergies: 2006-2008
Restructuring and synergies: 2006 – 2008 Global Emerging Supply Chain SG&A R&D AstraTech Biologics Markets 0 -1000 -2300 -2000 -3000 -4000 -5000 -6000 -7000 -8000 2006-2008 headcount movements are shown on a Full Time Equivalent basis and include AZ employees and contractors AstraZeneca Annual Resul
Slide 30: Restructuring and synergies: Expanded scope
Restructuring and synergies: Expanded scope 2007-2008 Total Programme Cost Headcount Reduction Original Cost to Date Guidance Latest View Original $m $m $m Guidance Latest View Global Supply Chain (820) (750) (1,250) 3,300 6,150 SG&A (806) (850) (1,400) 3,600 7,450 R&D (221) (375) (300) 700 1,400 To
Slide 31: Cash generation: FY08
Cash generation: FY08 2008 2007 $m $m Opening net cash/(debt) (9,112) 6,537 EBITDA 11,764 9,950 Movement in working capital (210) (443) Interest paid (690) (335) Tax paid (2,209) (2,563) Other non-cash movements 87 901 Net cash from operating activities 8,742 7,510 AstraZeneca Annual Results 2008
Slide 32: Cash generation: FY08
Cash generation: FY08 2008 2007 $m $m Opening net cash/(debt) (9,112) 6,537 Net cash from operating activities 8,742 7,510 Merck (2,630) - Net Acquisitions (incl. MedImmune) - (14,891) Other capital expenditure (1,371) (1,625) Dividends/Net share buy-back (3,190) (6,593) Other movements 387 (50) Clo
Slide 33: 2009 performance priorities
2009 performance priorities Drive growth of key brands and markets Life Cycle Management Sales and Marketing Effectiveness Emerging Markets Progress productivity initiatives and restructuring Increased focus on cash management Continued investment in R&D AstraZeneca Annual Results 2008
Slide 34: Guidance for 2009 (Core basis)
Guidance for 2009 (Core basis) Sales In line with FY08 level at CER Core EPS Growth at CER Gross Margin Slightly ahead of FY08 level (CER) SG&A Flat at CER R&D Other Income Higher than FY08 on disposable gains Net Finance Expense Higher than FY08 Tax Rate ~ 29.5% AstraZeneca Annual Results 2008
Slide 35: Currency basis for 2009 guidance
Currency basis for 2009 guidance Currency: January 2009 average rates: $1 = £0.691 $1 = €0.751 $1 = SEK 8.081 $1 = JPY 90.3 Core EPS range of $5.15 to $5.45 Actual 2009 rates may differ materially from January 2009 rates upon which guidance is based 2009 currency sensitivity estimator is ava
Slide 36: Core EPS adjustments
Core EPS adjustments 2008 2009 est. Restructuring/Synergy $0.43 ~$0.24 MedImmune amortisation $0.21 ~$0.21 Merck amortisation $0.07 ~$0.07 Impairments $0.19 AstraZeneca Annual Results 2008
Slide 37: Distribution policy
Distribution policy Dividends Second interim dividend increased by 11% to $1.50 Full year increase of 10% to $2.05 To grow in line with reported earnings (pre-restructuring costs) maintaining at least 2x dividend cover Share repurchases Reflective of stated financial priorities No shar
Slide 38: Annual Results 2008
Ast azeneca Annual Results 2008
Slide 39: John Patterson, Executive Director, Development
John Patterson Executive Director, Development
Slide 40: Delivering on our promise
Delivering on our promise Differentiated 2008 achievements & Targeted Medicines 2 NCE submissions 8 New Life Cycle Management submissions 18 Phase II starts Ongoing productivity improvements Faster cycle times Leaner & cost efficient organisation Strengthen Investment in externalisatio
Slide 41: Phase III portfolio
Phase III portfolio Pre- Clinical Phase I Phase II Phase III portfolio LCM PN400 ONGLYZA™ Crestor/ TriLipix Zactima Recentin Recentin Brilinta (AZD6140) Dapagliflozin ZD4054 Motavizumab AstraZeneca Annual Results 2008
Slide 42: Phase III update CVGI - ONGLYZA
Phase III update CVGI – ONGLYZA™ Delivered NDA submission Jun 08 EU MAA Jul 08 (15 months early) Over 5,000 individuals involved in clinical trials No CV safety signal Registration process ongoing US – PDUFA date end of April EU – Accepted for review by CHMP AstraZeneca Annual Results
Slide 43: Phase III update CVGI
Phase III update CVGI Project Update Dapagliflozin Phase IIb data presented at ADA an EASD 08 4 of 9 ongoing Phase III studies fully recruited 6 month interim data of 2 pivotal studies available in-house – 1H09 Expanding alliance and development to Japan Brilinta (AZD6140) PLATO completed recruitmen
Slide 44: Phase III update CVGI & CNS/Pain
Phase III update CVGI & CNS/Pain Project Update Crestor/TriLipix TriLipix monotherapy approved by FDA – Dec 08 FDC NDA on target for 3Q09 AZD0837 Investigating a stability limitation with formulation Making progress in resolving Estimated start of Phase III – 2H09 PN400 On track for mid 2009 NDA Fir
Slide 45: Phase III Update Oncology - Zactima
Phase III Update Oncology – Zactima All four Phase III studies completed recruitment on schedule: ZEST (monotherapy vs erlotinib) ZODIAC (docetaxel combination) ZEAL (pemetrexed combination) ZEPHYR (monotherapy in EGFR failure) ZODIAC is the pivotal study, clinical benefits supported by ZEAL Ast
Slide 46: Phase III Update Oncology - Zactima
Phase III Update Oncology – Zactima Plan to file Zactima (100mg combination) submission for NSCLC – 2Q09 ZEST showed Zactima 300mg monotherapy has non-inferior efficacy to erlotinib and will support a monotherapy indication based on positive ZEPHYR data ZEPHYR completed recruitment and will re
Slide 47: Phase III update Oncology - Recentin
Phase III update Oncology – Recentin CRC Go into Phase III as achieved efficacy trigger – Feb 08 HORIZON Phase III recruitment completed on schedule (end 08) On track for submissions – 2H10 Recurrent Glioblastoma Phase III REGAL study recruiting On track for submission – 2H10 NSCLC
Slide 48: Phase III update Oncology - ZD4054
Phase III update Oncology – ZD4054 ENTHUSE programme actively recruiting M1 study ahead of schedule Phase II (EPOC - Study 6) results published in European Urology – Dec 08 1.0 0.9 0.8 0.7 Proportion of patients alive Placebo 0.6 ZD4054 15 mg ZD4054 10 mg 0.5 0.4 0.3 0.2 0.1 0.0 0 50 100 150 2
Slide 49: Phase III & LCM Update Biologics
Phase III & LCM Update Biologics Motavizumab US BLA for premature and CLD – 1Q08 Received CRL from FDA in 4Q08 Further clarifications expected in discussions with the FDA – Feb 09 Timeline for completion of response to CRL and subsequent filing of applications with EMEA to be determined af
Slide 50: LCM update Unit Dose Budesonide
LCM update Unit Dose Budesonide Collaboration signed with MAP Pharmaceuticals to develop and commercialise Unit Dose Budesonide (UDB) for paediatric asthma Compatible with new generation of nebulisers Potential to be nebulised more quickly than commercially available product Subject to revie
Slide 51: LCM update Crestor
LCM update Crestor Crestor outcomes programme showing strong safety data JUPITER demonstrated unprecedented risk reduction Regulatory submission – 2Q09 Successful repeat MRP process gained approval in 5 new EU markets Crestor EU Paediatric Plan progressing JUPITER Primary Endpoint Placebo
Slide 52: LCM update Seroquel
LCM update Seroquel Regulatory update: Filed Approval 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 1Q 2009 EU IR Bipolar Depression IR Bipola
Slide 53: LCM update Symbicort
LCM update Symbicort sNDA delivered in US for COPD PDUFA date – Feb 09 sNDA delivered in US for paediatric asthma – Jun 08 pMDI filing in UK for asthma/COPD – Sept 08 Japan anticipated approval 4Q09 due to agency resources FDA Advisory Committee on benefits/risks of LABA containing produ
Slide 54: LCM update Iressa
LCM update Iressa IPASS (Iressa Pan-Asia Study) Iressa vs carboplatin/paclitaxel in 1st line adv NSCLC in a selected patient population Superior progression-free survival (PFS) for Iressa compared to doublet chemotherapy More favourable tolerability profile and superior quality of life (QoL)
Slide 55: Faster, Leaner, Better
Faster, Leaner, Better Quality driving cost and speed Leaner Quality $100m MedImmune synergies Continuous Improvement PERFORMANCE Clinical data outsourcing of 82 studies 5 drug campaigns supplied from Cost Speed Bangalore at 1/3rd cost More Cost Effective Completed Phase I cycle times and
Slide 56: Stronger pipeline: January 2008
Stronger pipeline: January 2008 Seroquel XR AZD2836 Seroquel XR AZD2207 Crestor AZD0837 Seroquel XR MEDI-534 AZD2327 Zactima Nexium sachet CMV vaccine AZD1940 AZD4818 MEDI-528 formulation CAT-8015 AZD1386 AZD0328 EBV vaccine* Atacand CAM-3001 AZD1305 AZD5904 CytoFab ONGLYZA ™* Symbicort AZD8931 AZD1
Slide 57: Stronger pipeline: Withdrawals
Stronger pipeline: Withdrawals Seroquel XR AZD2836 Seroquel XR AZD2207 Crestor AZD0837 Seroquel XR Withdrawn MEDI-534 AZD2327 Zactima No NoChange Change Nexium sachet CMV vaccine AZD1940 AZD4818 MEDI-528 formulation CAT-8015 AZD1386 AZD0328 EBV vaccine* Atacand CAM-3001 AZD1305 AZD5904 CytoFab ONGLY
Slide 58: Stronger pipeline: Withdrawals
Stronger pipeline: Withdrawals Seroquel XR Seroquel XR Crestor AZD0837 Seroquel XR MEDI-534 AZD2327 Zactima Nexium sachet CMV vaccine AZD1940 MEDI-528 formulation CAT-8015 AZD1386 EBV vaccine* Atacand CAM-3001 AZD1305 CytoFab ONGLYZA ™* Symbicort AZD8931 AZD1236 AZD9056 Motavizumab pMDI AZD9056 AZD8
Slide 59: Stronger pipeline: Progressions
Stronger pipeline: Progressions Seroquel XR*** New Filing Seroquel XR Crestor*** Progression AZD0837 Seroquel XR No Change MEDI-534 AZD2327 Zactima Nexium sachet CMV vaccine AZD1940 MEDI-528 Formulation*** CAT-8015 AZD1386 EBV vaccine* Atacand CAM-3001 AZD1305 CytoFab ONGLYZA ™* Symbicort AZD8931 AZ
Slide 60: Stronger pipeline: Progressions
Stronger pipeline: Progressions AZD1305 New Filing AZD1236 Seroquel AZD1152 Seroquel XR Progression AZD0837 Seroquel XR No Change MEDI-534 Recentin Atacand CMV vaccine MEDI-528 Zactima CAT-8015 EBV vaccine* Symbicort CAM-3001 CytoFab MEDI-563 ONGLYZA ™* pMDI AZD8931 AZD9056 AZD9056 MEDI-545 Motavizu
Slide 61: Stronger pipeline: Additions
Stronger pipeline: Additions AZD1305 Seroquel AZD1236 Seroquel XR Addition AZD1152 Seroquel XR No Change MEDI-534 AZD8529 AZD0837 Atacand CMV vaccine AZD8075 Recentin AZD7295 Zactima CAT-8015 AZD8055 MEDI-528 AZD1656 Symbicort CAM-3001 AZD6918 EBV vaccine* MEDI-563 ONGLYZA ™* pMDI AZD8931 AZD4017 Cy
Slide 62: Stronger pipeline: January 2009
Stronger pipeline: January 2009 New Filing Progression AZD1305 Seroquel AZD1236 Seroquel XR Addition AZD1152 Seroquel XR No Change MEDI-534 AZD8529 AZD0837 Atacand CMV vaccine AZD8075 Recentin AZD7295 Zactima*** CAT-8015 AZD8055 MEDI-528 AZD1656 Symbicort CAM-3001 AZD6918 EBV vaccine* MEDI-563 ONGLY
Slide 63: Delivering on our promise: Strengthening the pipeline
Delivering on our promise: Strengthening the pipeline 2007 – 2008 Better vertical distribution across the phases 144 137 Significant flow into Phase I 24 23 in 2007 translated into a 120 91 106 10 10 record year for 2008 25 20 Phase II entries 25 25 31 5 Clinical 5 6 18 6 Projects reached appr
Slide 64: Delivering on our promise: 2004 - 2008
Delivering on our promise: 2004 – 2008 Optimise marketed products through LCM Increase discovery output Speed up development processes Improve quality of molecules Strengthen portfolio through externalisation and biologics AstraZeneca Annual Results 2008
Slide 65: Delivering on our promise: Bringing new medicines to markets
Delivering on our promise: 2004 – 2008 Bringing new medicines to markets NMEs up 86% since 2004 LCM; 33 significant approvals since 2005 300 +138% Mix; Improved mix of NMEs v LCM 250 +100% +100% 200 NME Submissions; +48% FY 2004 150 FY 2008 -8% 2 NMEs submitted in 2008 100 (Motavizumab and O
Slide 66: Delivering on our promise: Strategically positioned for long-term success
Delivering on our promise: 2004 – 2008 Strategically positioned for long-term success Focused Disease Area Strategy Major review in 2006 Refined in 2007 Albireo GI spin-off Feb 2008 Jan 2005 Jan 2009 Biologics 25% Creation of a significant biologics portfolio 2% - approx. one quarter of
Slide 67: Conclusions
Conclusions A bigger better pipeline Developing progressively towards our 2010 goals of 2 new product launches pa on average 8 year median development cycle time Life Cycle Programmes for all major products Jupiter could change cardiology Improved efficiency and effectiveness A CULTURE
Slide 68: Annual Results 2008
Ast azeneca Annual Results 2008
Slide 69: David Brennan, CEO
David Brennan CEO
Slide 70: Summary
Summary Robust performance in challenging conditions Earnings growth ahead of sales growth Expanded scope of restructuring Investing to drive long-term performance AstraZeneca Annual Results 2008