Slide 1: AstraZeneca 2Q and Half Year 2014 Results
AstraZeneca 2Q and Half Year 2014 Results 1
Slide 2: Cautionary statement regarding forward-looking statements
Cautionary statement regarding forward-looking statements In order, among other things, to utilise the 'safe harbour' provisions of the US Private Securities Litigation Reform Act 1995, we are providing the following cautionary statement: This presentation contains certain forward-looking statements
Slide 3: Agenda
Agenda Pascal Soriot 2Q and Half Year 2014 overview Briggs Morrison 2Q and Half Year 2014 pipeline update Marc Dunoyer 2Q and Half Year 2014 financial performance Pascal Soriot Closing remarks 3 3
Slide 4: 2Q and Half Year 2014 overview
2Q and Half Year 2014 overview Pascal Soriot, Chief Executive Officer 4 4
Slide 5: 2Q 2014: Highlights
2Q 2014: Highlights Returning to growth Second consecutive quarter of revenue growth; $6,454m, +4% (CER) Core EPS +13% in 2Q; -1% YTD (CER) Continued double-digit growth in Emerging Markets; China +23% (CER) Excellent US Farxiga launch progress Almirall deal to bolster respiratory franchis
Slide 6: 1H 2014: Positive revenue growth
1H 2014: Positive revenue growth 1H 14 CER $m growth % Global Revenue 12,870 3 US 4,951 5 Europe 3,277 (2) Emerging Markets 2,881 11 China 1,108 23 Japan 1,116 1 Core EPS $2.47 (1) 6 6
Slide 7: Continued good progress in 1H on our strategic priorities
Continued good progress in 1H on our strategic priorities 1 2 3 Achieve Return Be a great place scientific to growth to work leadership 7 7
Slide 8: 1H 2014: Growth platform revenue up 14% to $6.8bn
2 1H 2014: Growth platform revenue up 14% Return to growth to $6.8bn Absolute revenue growth (CER) Diabetes +128%* Excellent US Farxiga launch progress Double digit growth two consecutive quarters, Emerging Markets +23% +11% led by China growth (+23%) Respiratory +9% Strong Symbicort growth in US Br
Slide 9: 1H 2014: Growth platforms & resilience of mature products, offsets LoE headwind
2 1H 2014: Growth platforms & resilience of Return to growth mature products, offsets LoE headwind Absolute revenue growth (CER) Diabetes Excellent US Farxiga launch progress Symbicort Strong growth in US (+25%) and Japan (+68%) Brilinta Doubling sales in US, continued momentum in EU (+54%) Pulmicor
Slide 10: Brilinta: Continued momentum in the US
2 Brilinta: Continued momentum in the US Return to growth $m 140 120 EM 100 $16m 2Q revenue up 77% to $117m EST ROW $8m 80 US is fastest growing region quarter EUR over quarter, +28% 60 $58m 40 Continued strong performance in ROW, +13% quarter over quarter 20 US $35m 0 2Q 13 2Q 14 10 Note: Gro
Slide 11: Brilinta: Regaining share growth momentum in the US
2 Brilinta: Regaining share growth momentum Return to growth in the US Monthly brand share – Oral anti-platelet (OAP) class TRx Share NBRx Share 8.0% 7.0% 6.9% 6.0% 6.3% 6.1% 5.0% 4.0% 3.7% 3.0% 2.3% 2.1% 2.0% 1.8% 1.0% 0.9% 0.8% 0.1% 0.0% 11 Source: IMS Health NPA, Monthly data through June, 2014 1
Slide 12: Brilinta: Regaining momentum in hospital initiation in the US
2 Brilinta: Regaining momentum in hospital Return to growth initiation in the US Share of OAP Inpatient Units Purchased (MMT) STEMI discharge ACS share (MQT) 4.5% All Hospital Targets (n=2568) 60% Clopidogrel Prasugrel BRILINTA 4.1% 50% 4.0% 44% 40% 3.5% 33% 30% 3.0% 23% 20% 2.5% 10% 12 Source: IMS
Slide 13: Diabetes: Excellent Farxiga launch in the US
2 Diabetes: Excellent Farxiga launch in the US Return to growth $m 500 Others $63m 450 Farxiga is most successful US 400 Bydureon launch in oral NIAD market since $112m 350 Januvia, 40% NBRx share among 300 Byetta SGLT-2s $88m 250 Onglyza US TRx share: 0.3 share 200 point decline since March 201
Slide 14: Diabetes: Continued strong Farxiga launch, growing SGLT-2 class
2 Diabetes: Continued strong Farxiga launch, Return to growth growing SGLT-2 class Monthly NRx volume – launch aligned (US) Monthly NRx volume – SGLT-2 class (US) 60,000 Onglyza (2009) Tradjenta (2011) 100,000 Farxiga launch – Bydureon (2012) Victoza (2010) driving class growth Farxiga (2014) Invoka
Slide 15: Respiratory: Continued strong Symbicort growth in US
2 Respiratory: Continued strong Symbicort Return to growth growth in US $m 1,000 EM 900 $84m 2Q Symbicort revenue +9% 800 EST ROW $96m 700 Symbicort TRx share up 4.7 points 600 EUR in US vs end of 2013 $371m 500 EU sales -7%, due to pricing 400 pressure 300 US 200 $377m 2Q Emerging Markets +
Slide 16: Respiratory: Strong Symbicort US share performance
2 Respiratory: Strong Symbicort US share Return to growth performance Monthly brand share 2012 Share 2013 Share +3.8 39% Growth Growth 37.7% 33.9% 34% +1.7 +5.7 +4.7 31.0% 29% 28.1% 26.3% +2.2 +3.9 24% 22.4% 19% NTC Share TRx Share 16 Source: IMS Health NPA, Monthly data through June, 2014 16
Slide 17: Emerging Markets: AstraZeneca fastest growing MNC in China YTD
2 Emerging Markets: AstraZeneca fastest Return to growth growing MNC in China YTD Top 10 MNC YTD hospital sales Growth rate 10.8% Pfizer 15.4% 27.6% AstraZeneca 25.4% 6.4% Bayer 9.9% 10.6% Sanofi 9.7% 3.9% Roche 10.8% 16.5% Novartis 22.9% 16.1% M.S.D 17.4% 7.0% Novo Nordisk 10.4% -28.8% GSK -22.6% 1
Slide 18: Emerging Markets: AstraZeneca continues to outpace the market in China
2 Emerging Markets: AstraZeneca continues Return to growth to outpace the market in China MAT sales growth hospital market 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% Total China LOCAL MNC AZ 18 *MNC: multi national companies Source: IMS 14M05 data. 18
Slide 19: Japan: Positive underlying demand for launch brands
2 Japan: Positive underlying demand for launch Return to growth brands Volume market share 2014 vs 2013 (May YTD) +1.3% Continued share growth for Crestor, +3.1% Symbicort & Nexium In-market growth +8.4% (May YTD) +7.0% Negative 2Q impact from biennial price reductions & increased utilisation
Slide 20: 2Q and Half Year 2014: Pipeline update
2Q and Half Year 2014: Pipeline update Briggs Morrison, Executive Vice President Global Medicines Development 20
Slide 21: 2Q 2014: new NME pivotal study starts contributing to growing late stage pipeline
1 2Q 2014: 4 new NME pivotal study starts Achieve scientific contributing to growing late stage pipeline leadership Pivotal study starts in 2Q 2014 Number of NMEs in pivotal studies 14 roxadustat (HIF) CKD & ESRD tremelimumab (CTLA-4) mesothelioma 11 NMEs AZD9291 (EGFR) 2L NSCLC 9-10 PD-L1 (MEDI4736
Slide 22: 2Q 2014: Continued momentum in late stage pipeline
1 2Q 2014: Continued momentum in late stage Achieve scientific pipeline leadership Regulatory milestones Compound Indication Milestone Epanova hypertriglyceridaemia US approval Movantik OIC AADPAC vote positive AZD0914 bacterial infection Granted fast track status by FDA Bydureon Dual Chamber Pen ty
Slide 23: IO portfolio and clinical collaborations target multiple steps of immune response
1 IO portfolio and clinical collaborations target Achieve scientific multiple steps of immune response leadership Optimising T-cell function and memory Brakes Off: PD-L1, PD-1, CTLA-4 Gas On: OX40 Antigen presentation Inhibition by microenvironment Radiation IDO Chemotherapy CCR4 Small
Slide 24: Immuno-oncology portfolio progressing well
1 Immuno-oncology portfolio progressing well Achieve scientific leadership Ongoing sponsored and/or pivotal studies Planned sponsored and/or pivotal studies PD-L1 Ph I solid tumours PD-L1 Ph III 3L NSCLC PD-L1 Ph I/II MDS PD-L1 Ph III Adjuvant NSCLC PD-L1 Ph II 3L NSCLC * PD-L1 + radiation Ph I soli
Slide 25: Anti-PDL1 and anti-PDL1 + tremelimumab in cancer of head and neck (SCCHN)
1 Anti-PDL1 and anti-PDL1 + tremelimumab in Achieve scientific cancer of head and neck (SCCHN) leadership Before anti-PDL1 infusion After two anti-PDL1 infusions (30 days) SCCHN 2nd tumour type to initiate pivotal programme for PD-L1 Plans for pivotal programme with both PD-L1 monotherapy and PD-L
Slide 26: AstraZeneca/MedImmune at the forefront of innovative, biomarker-driven trial design
1 AstraZeneca/MedImmune at the forefront of Achieve scientific innovative, biomarker-driven trial design leadership Lung-MAP1: Randomised, multi-drug, Ph II/III, Recurrent Stage IIIB-IV Squamous Cell Lung Cancer GDC-0032 vs PI3KCA+ SCLC docetaxel CDK4/6+ and Palbociclib vs CCND1-3+ SCLC docetaxel Ge
Slide 27: Movantik: Potential first QD oral PAMORA with a targeted mechanism of action for OIC
1 Movantik: Potential first QD oral PAMORA Achieve scientific with a targeted mechanism of action for OIC leadership Patients achieving primary efficacy endpoint1 OIC2 frequency among opioid treated patients Placebo Naloxegol 12.5 mg Naloxegol 25 mg 50 * 100% * 44.4 45 40.8 * 39.7 40 81% 34.9 35 Pat
Slide 28: Roxadustat: Frequency of anemia increases with CKD3 progression
1 Roxadustat: Frequency of anemia increases Achieve scientific with CKD3 progression leadership Novel oral erythropoiesis stimulating agent Est. prevalence of CKD & Anemia1 by stage 100 US China HIF increases iron Proportion of Anemia in each CKD stage absorption in the 90 GI tract 80 HIF increases
Slide 29: Roxadustat: Phase III starts to support US filing 2018 in Chronic Kidney Disease
1 Roxadustat: Phase III starts to support US Achieve scientific filing 2018 in Chronic Kidney Disease leadership OLYMPUS: Randomised, Ph III, Chronic Kidney Disease (CKD) roxadustat Non-dialysis Primary end-point: MACE dependent CKD MACE First Subject-in: Q2 2014 with anemia Data read-out: Q1 2017 p
Slide 30: 2014: Continued strong momentum in late stage pipeline
1 2014: Continued strong momentum in late Achieve scientific stage pipeline leadership BACE (AZD3293) Alzheimer’s disease tenapanor (NHE3) ESRD anifrolumab (IFN-αR) SLE roxadustat (HIF) sifalimumab (IFN-α) CKD & ESRD SLE NMEs tremelimumab (CTLA-4) mavrilimumab (GM-CSF) mesothelioma RA AZD9291 (EGFR)
Slide 31: ESC 2014: Highlights
1 ESC 2014: Highlights Achieve scientific leadership ATLANTIC: Randomised, Ph IV Pre-hospital In-hospital 30 days Ticagrelor Placebo Co-primary end-points: TIMI flow grade 1:1 180 mg STEMI planned for Ticagrelor 3/ ST-segment resolution PCI n=1874 90 mg BiD Data presentation: ESC 2014 Ticagrelor Pla
Slide 32: ESMO 2014: Highlights
1 ESMO 2014: Highlights Achieve scientific leadership Immuno-oncology Small molecules PD-L1 monotherapy data AZD9291 data in NSCLC: including PD-L1 + CTLA-4 data in NSCLC: More duration of response, 1st line EGFR M+ patients, further dosing cohorts and PD- and brain metastases L1 biomarker sta
Slide 33: 2H 2014: Key data readouts
1 2H 2014: Key data readouts Achieve scientific leadership Compound Indication Milestone lesinurad gout Ph III topline results CAZ AVI cIAI Ph III topline results brodalumab psoriasis Ph III topline results sifalimumab SLE Ph IIb (ACR) mavrilimumab RA Ph IIb (ACR) MEDI4736 solid tumours Ph I (ESMO)
Slide 34: 2H 2014: Key regulatory milestones
1 2H 2014: Key regulatory milestones Achieve scientific leadership Compound Indication Potential milestones Iressa EGFRm NSCLC US filing Movantik OIC US approval (PDUFA 16 Sep 2014) Movantik OIC EU approval Brilinta ACS JP approval olaparib PSR BRCAm ovarian cancer US approval (PDUFA 3 Jan 2015) Xig
Slide 35: Potential NME & LE submissions 2014-16
1 Potential NME & LE submissions 2014-16 Achieve scientific leadership Myalept EU lipodystrophy PT003 LABA/LAMA COPD PT001 LAMA COPD CAZ AVI EU brodalumab* PD-L1 (MEDI4736) cephalosporin/BLI SBI IL-17R psoriasis NSCLC lesinurad AZD9291 US/EU/JP benralizumab NMEs URAT1 gout EGFR T790M NSCLC IL-5R ast
Slide 36: 2Q and Half Year 2014: Financial performance
2Q and Half Year 2014: Financial performance Marc Dunoyer, Chief Financial Officer 36
Slide 37: 2Q 2014: Headline results
2Q 2014: Headline results 2Q 2Q CER 2014 2013 growth % Revenue 6,454 6,232 4 Core Operating Profit 2,031 2,056 2 Core EPS $1.30 $1.20 13 37 37
Slide 38: 2Q 2014: Core margin
2Q 2014: Core margin CER % $m growth % sales Revenue 6,454 4 Core Gross Profit 5,298 4 82.1 Distribution (77) 2 1.2 Core R&D (1,208) 12 18.7 Core SG&A (2,460) 13 38.1 Core Other Income 478 120 7.4 Core Operating Profit 2,031 2 31.5 38 38
Slide 39: 1H 2014: Core margin
1H 2014: Core margin 1H 2014 1H 2013 CER % $m $m growth % sales Revenue 12,870 12,617 3 Core Gross Profit 10,521 10,376 3 81.7 Distribution (149) (153) (2) 1.2 Core R&D (2,306) (2,003) 13 17.9 Core SG&A (4,777) (4,228) 13 37.1 Core Other Income 694 388 80 5.4 Core Operating Profit 3,983 4,380 (5) 30
Slide 40: Strategic Transaction with Almirall in Respiratory Disease
Strategic Transaction with Almirall in Respiratory Disease Accelerating AstraZeneca Respiratory Leadership 40
Slide 41: Long-term value generation and strong strategic fit
Long-term value generation and strong strategic fit Stronger inhaled portfolio in asthma and COPD Greater device choice for patients (DPI and pMDI)1 Short-term: adds DPI twice daily LAMA & LABA/LAMA options to Symbicort/ Pearl Medium-term: offers once daily treatment options with novel MABA an
Slide 42: Summary Transaction Overview
Summary Transaction Overview Assets and Rights Acquired Development & commercial rights in un-partnered territories for Eklira® (LAMA) and Aclidinium LAS40464 (LAMA/LABA) franchise Assume Almirall rights in partnered territories Global development & commercial rights on MABA platform LAS190792
Slide 43: Progressing AstraZeneca leadership in Respiratory
Progressing AstraZeneca leadership in Respiratory Revenue & access to Strengthen device in-market portfolio Strengthen pipeline offering & know-how Eklira® Genuair® QD MABA Device Growing, marketed product New class of bronchodilators DPI platform additive to BiD LAMA in preferred DPI AstraZ
Slide 44: Guidance for 2014 (updated)
Guidance for 2014 (updated) 2014 Revenue (CER) In line with 2013 2014 Core EPS (CER) Low double-digit decrease Dividend Progressive dividend policy maintained Planning assumptions Above guidance assumes US Nexium generic on 1 October 2014. No impact on guidance from the Almirall deal. The Comp
Slide 45: 2Q 2014: Closing remarks
2Q 2014: Closing remarks Pascal Soriot, Chief Executive Officer 45 45
Slide 46: Closing remarks
Closing remarks Revenue and Core EPS growth in 2Q Almirall deal to bolster respiratory franchise Guidance updated; dividend policy confirmed Strong News Flow in 2H 2014; Investor Day 18 November 46 46
Slide 47: AstraZeneca 2Q and Half Year 2014 Results
AstraZeneca 2Q and Half Year 2014 Results 47