Slide 1: Year-To-Date and Q3 2015 Results
Year-To-Date and Q3 2015 Results 5 November 2015
Slide 2: Forward-looking statements
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 document contains certain forward-looking statements with respect to the operations,
Slide 3: Agenda
Agenda Overview Pascal Soriot Products Luke Miels Finance Marc Dunoyer Pipeline Sean Bohen Closing Pascal Soriot 3
Slide 4: Highlights
Highlights • Total Revenue $18.3bn, stable – Growth platforms: +10%, now 57% of total1 – Resilient top line underpins increased R&D • Core EPS $3.32, +2% and +8% in Q3 – 2015 Core SG&A cost reduction on track • Continuous strong newsflow – Pipeline progress continued with one approval and several re
Slide 5: Strong Q3 pipeline newsflow
Strong Q3 pipeline newsflow Regulatory decisions On track to deliver 7-8 potential regulatory • Brilinta - post-MI1 (US): Approved submissions for new medicines in 2015-2016 • saxa/dapa - type-2 diabetes (US) Complete ü CAZ AVI (CEPH/BLI) Response Letter: Delayed serious infections ü cediran
Slide 6: Growth Platforms continue to deliver
Growth Platforms continue to deliver Leveraging stable revenues down the P&L YTD 2015 % Q3 2015 % $m change $m change Total Revenue 18,309 - 5,945 (2) Core EPS $3.32 +2 $1.03 +8 YTD Growth Platforms +10%;; 57% of Total Revenue Total Revenue and Core EPS at actual exchange rates. Growth rates at CER
Slide 7: Products
Products Luke Miels EVP, Global Product & Portfolio Strategy, Global Medical Affairs and Corporate Affairs
Slide 8: Growth Platforms: Progress across all areas
Growth Platforms: Progress across all areas YTD 2015 % Q3 2015 % $m change $m change Growth Platforms 10,354 +10 3,455 +8 Respiratory 3,698 +8 1,230 +7 Brilinta/Brilique 445 +44 170 +48 Diabetes 1,638 +26 577 +17 Emerging Markets 4,394 +12 1,427 +10 Japan 1,479 +3 502 +6 Product Sales at actual exch
Slide 9: Respiratory: Strength in Emerging Markets
Respiratory: Strength in Emerging Markets Growth supported by new products Particular strength in Emerging Markets $m $m 1,500 US +10% 4,000 +8% +7% • Symbicort Product Sales (1)% due to access +103% +139% support and price;; volume positive • Tudorza and Daliresp;; good uptake 3,000 1,000 +17% +16%
Slide 10: Brilinta/Brilique: Growth in all markets
Brilinta/Brilique: Growth in all markets US oral anti-platelet class market First approval b ased o n Growth u ptick in many markets share n ew-to-brand p rescriptions PEGASUS trial $m $m 12% US Brilinta 500 +44% +48% 11% Competitor • September approval of expanded 10.1% label for use beyond one
Slide 11: Diabetes: Global franchise growth continues
Diabetes: Global franchise growth continues Q3 growth continued at high level Strong growth in all markets $m $m 2,000 US +15% +26% +17% • Continued strong Bydureon, Farxiga growth;; Onglyza reduced by competition 1,500 +180% +107% 500 EU +41% (1)% (17)% 1,000 • Persistent Onglyza increase;; strong
Slide 12: Emerging Markets: Continued high growth
Emerging Markets: Continued high growth Growth continued at double digits Broad-based performance Emerging Markets • Presence in main therapy areas and strong +13% +12% +12% underlying trends support continued growth +10% +8% +4% • Respiratory +32%;; driven by Pulmicort (~53% of total) and Symbicor
Slide 13: Japan: Continued solid growth
Japan: Continued solid growth Product Sales Leading d ynamic p atient share Company rank YTD 2015 $m 38% 400 +6% 32% Blocked by data 29% +16% 28% provider 300 22% 21% 200 +3% Blocked by data 100 provider Symbicort Nexium Crestor 0 AZ Closest competitor Symbicort Nexium Crestor Long-term target: Low
Slide 14: Launch medicines: Progressing according to plan
Launch medicines: Progressing according to plan Lynparza Iressa US Movantik/Moventig Opioid-induced constipation in adults with BRCA-mutated advanced ovarian cancer 1st-line EGFR-mutated metastatic NSCLC chronic non-cancer pain US cumulative new patient starts 120 US cumulative new patient star
Slide 15: Finance
Finance Marc Dunoyer Chief F inancial Officer
Slide 16: YTD 2015: Financials in-line
YTD 2015: Financials in-line • Total Revenue $18.3bn, stable – Growth Platforms +10%, now 57% of total1 • Core Gross Margin over 83%, up 1.0% points • Operating costs – Core SG&A: Fully on track to reduce costs year-on-year – Core R&D costs: Continued investment, including Immuno-Oncology combo
Slide 17: Profit & Loss
Profit & Loss YTD 2015 Change % Total Q3 2015 Change ($m) (%) Revenue ($m) (%) Total Revenue 18,309 - 5,945 (2) Product Sales 17,434 (2) 95 5,850 (2) Externalisation Revenue 875 +112 5 95 +50 Core Cost of Sales (2,910) (8) 16 (992) (8) Core Gross Profit 15,399 +2 831 4,953 - Core R&D (4,036) +22 2
Slide 18: Core SG&A: In-line to deliver year-on-year reduction
Core SG&A: In-line to deliver year-on-year reduction 2015 Core SG&A cost reduction on track Core SG&A commitment and status $bn Q3 Core SG&A 3.5 SM&M G&A (3)% • Commitment to reduce 2015 Core SG&A 3.0 Year-on-Year – Absolute value 2.5 YTD Core SG&A ratio 2.0 (1.3)% – and relative to Total Reven
Slide 19: FY 2015 guidance
FY 2015 guidance Upgraded today New Old In line with the prior Low single-digit Total Revenue year percent decline New Old Mid to high single-digit Low single-digit Core EPS percent increase percent increase The Company also provides the following non-guidance information related to currency sen
Slide 20: Pipeline
Pipeline Sean Bohen EVP, Global Medicines Development & Chief Medical Officer
Slide 21: Global Medicines Development leadership team
Global Medicines Development leadership team “Translate scientific knowledge to good clinical experiments to new medicines for patients” Science-led Focused execution Passion and commitment 21
Slide 22: Q3 late-stage pipeline highlights
Q3 late-stage pipeline highlights Respiratory, Inflammation & Cardiovascular & Metabolic Oncology Autoimmunity Disease • PT003 - COPD: Regulatory submission • Brilinta: Post-MI regulatory approval • AZD9291: Priority Review (US, JP);; acceptance (US) and Phase III data (US) and ACS/post-MI regul
Slide 23: Immuno-Oncology: Way to market
Immuno-Oncology: Way to market Data availability from key ongoing trials Other tumour types DETERMINE PII mesothelioma 2L (randomised) Head & neck cancer HAWK (fast-to-market) CONDOR PII 2L PD-L1 positive (single arm) PIII 2L PD-L1 negative Lung cancer CAURAL (combo AZD9291) PIII 2L T790M+ MYST
Slide 24: 2015-2016 key pipeline newsflow
2015-2016 key pipeline newsflow Regulatory approvals Key regulatory submissions Key Phase III readouts • lesinurad - gout (US) • brodalumab - psoriasis (US, EU) • durvalumab - lung cancer (PII) H1 2016 H1 2016 H1 2016 • benralizumab - severe asthma • AZD9291 - lung cancer • Brilinta/Brilique -
Slide 25: Summary
Summary Pascal Soriot Chief Executive Officer
Slide 26: Summary
Summary • Total Revenue $18.3bn, stable • Core EPS $3.32, +2% and +8% in Q3 • Continuous strong newsflow • Upgraded FY 2015 guidance • On track to deliver on medium and long-term goals Total Revenue and Core EPS at actual exchange rates. Growth rates at CER 26
Slide 27: Q&A
Q&A Pascal Soriot, Chief Executive Officer (Moderator) Marc Dunoyer, Chief Financial Officer Luke Miels, EVP, Global Product & Portfolio Strategy, Global Medical Affairs and Corporate Affairs Sean Bohen, EVP, Global Medicines Development & Chief Medical Officer and other key members of the AstraZene