Financial highlights1

  • Total Revenue stable in the YTD at $18,309m.
  • Resilient top-line performance underpinned continued investment in R&D. Core R&D costs up by 18% in Q3, reflecting the recent start of key Oncology trials.
  • Core SG&A costs increased by 2% in the YTD; a decline of 3% in the third quarter.
  • Core EPS in the year to date up by 2%; with Q3 Core EPS growth of 8%.

Full Year guidance upgraded, supported by top-line performance, a rising gross margin and disciplined cost management

  • Upgraded FY 2015 Total Revenue and Core EPS guidance at constant exchange rates
  • Total Revenue now expected to be in line with 2014 (prior guidance: a low single-digit percent decline versus the prior year) at CER.
  • Core EPS now expected to increase by mid to high single-digit percent versus 2014 (prior guidance: low single-digit percent increase versus the prior year).

Growth platforms grew by 10% in the year to date, representing 57% of Total Revenue

  • Respiratory: 8% growth, including 38% Q3 sales growth in Emerging Markets.
  • Brilinta/Brilique: 44% growth. Recent label update supported Q3 US growth of 73%.
  • Diabetes: 26% growth, including 73% Diabetes sales growth in Emerging Markets.
  • Emerging Markets: 12% growth. China sales growth of 17% (Q3 2015: +11%).
  • Japan: 3% growth, with Q3 sales growth of 6%.

Strong pipeline progress in Q3 across all main therapy areas; on track to deliver 7-8 regulatory submissions for new medicines over 2015/2016   

  • Respiratory, Inflammation & Autoimmunity: Regulatory submission accepted in the US for PT003 in COPD; Fast Track designation granted in the US for anifrolumab in lupus.
  • Cardiovascular & Metabolic Disease: Brilinta approved by US FDA for patients with a history of heart attack beyond one year and regulatory submission accepted in Japan for acute coronary syndrome and patients with a history of heart attack; Complete Response Letter received in the US for saxagliptin/dapaglifozin in type-2 diabetes.
  • Oncology: Further progress in lung-cancer franchise following recent Iressa US approval, with AZD9291 regulatory submission acceptance in Japan and Priority Review granted in the US and Japan; Fast Track designation granted in the US for tremelimumab (mesothelioma) and for durvalumab (head & neck cancer).

Rich pipeline news flow expected in coming months

  • Q4 2015: US regulatory decision for lesinurad (gout); data read-out for durvalumab (lung cancer).
  • H1 2016: Regulatory decisions on AZD9291 (lung cancer) and PT003 (COPD); data read-out for Brilinta (stroke), benralizumab (severe asthma), tremelimumab (mesothelioma) and Lynparza (breast cancer).
  • H2 2016: EU regulatory decisions on saxagliptin/dapaglifozin (type 2 diabetes) and CAZ-AVI (serious infection); data read-out for Brilinta (peripheral arterial disease) and durvalumab (head & neck cancer).

Pascal Soriot, Chief Executive Officer, commenting on the results, said:

"I'm pleased with our continued progress as we focus on executing our plans across our growth platforms and pipeline. While we have more work to do on the submission of saxagliptin/dapagliflozin combination in Diabetes, the significant label update for Brilinta was accompanied by submission acceptances and accelerated reviews in cancer, respiratory diseases and lupus. In particular, our exciting Oncology portfolio maintained its momentum with four Priority Review and Fast Track designations as well as supportive data at key congresses.

"Our financial performance in the year to date, including an 8% increase in Core EPS in the third quarter, underpinned today's upgrade to full-year guidance. 2016 will be a pivotal year in our strategic journey as we face the impact of loss of exclusivity to Crestor in the US. Looking ahead however, the continued performance of our growth platforms and upcoming launches will combine with our increasing focus on costs and cash generation to help offset short-term headwinds and return AstraZeneca to sustainable growth."

1All growth rates are shown at constant exchange rates.

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