3rd Quarter Results
5 November 2015
Year-To-Date and Q3 2015 Results
|YTD 2015||Q3 2015|
|$m||% change||$m||% change|
|Core3 Op. Profit||5,346||-||(7)||1,728||7||(2)|
|Reported Op. Profit||3,026||31||22||1,170||137||116|
- Core EPS in the year to date up by 2% with Q3 Core EPS growth of 8%
- Total Revenue stable in the year to date; Core Gross margin up by 1.0% points to 83.3%
- 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 declined by 3% in the third quarter; increased by 2% in the year to date
- Upgraded FY 2015 Total Revenue and Core EPS guidance at constant exchange rates
YTD Commercial Highlights
Growth platforms grew by 10%, representing 57% of Total Revenue:
1. Respiratory: +8%, including 38% Q3 sales growth in Emerging Markets
2. Brilinta/Brilique: +44%; Q3 US growth of 73%
3. Diabetes: +26%, including 73% sales growth in Emerging Markets
4. Emerging Markets: +12%. China sales growth of 17% (Q3 2015: +11%)
5. Japan: +3%, with Q3 sales growth of 6%
Achieving Scientific Leadership: Progress since the prior results announcement
|Regulatory Approvals||Brilinta - post-myocardial infarction (MI) (PEGASUS trial) (US)|
|Regulatory Submission Acceptances||PT003 - COPD (US)
Brilinta - acute coronary syndrome, post-MI (JP)
AZD9291 - lung cancer (JP)
|Other Key Developments||saxagliptin/dapaglifozin - type-2 diabetes (US): Complete Response Letter
AZD9291: Granted Priority Review by FDA and Japanese MHLW FDA Fast Track designation:
anifrolumab - lupus, tremelimumab - mesothelioma, 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."
FY 2015 Guidance
All guidance is shown at CER1.
|Total Revenue||In line with the prior year||A low single-digit percent decline versus the prior year|
|Core Earnings Per Share||A mid to high single-digit percent increase versus the prior year||A low single-digit percent increase versus the prior year|
Non-guidance information is also provided:
Based on average daily spot rates in the nine months to the end of September 2015, Total Revenue in FY 2015 is expected to decline by high single-digit percent, with Core EPS expected to be broadly in line with FY 2014. In addition, the majority of FY 2015 Externalisation Revenue is anticipated to have been realised in the first half of the year. Core R&D costs are expected to grow at a lower rate in the final quarter versus the year to date and the Company is committed to reducing Core SG&A costs in FY 2015 versus the prior year, both in terms of absolute value and relative to Total Revenue.
Pipeline: Forthcoming Major Newsflow
|Q4 2015||lesinurad - gout: Regulatory decision (US)
brodalumab - psoriasis: Regulatory submission (US, EU)
durvalumab - lung cancer: Data read-out
|H1 2016||PT003 - COPD: Regulatory decision (US)
benralizumab - severe asthma: Data read-out
Brilinta/Brilique - stroke: Data read-out
AZD9291 - lung cancer: Regulatory decisions
tremelimumab - mesothelioma: Data read-out
Lynparza - breast cancer: Data read-out
|H2 2016||Brilinta/Brilique - peripheral arterial disease: Data read-out
saxagliptin/dapaglifozin - type-2 diabetes (EU): Regulatory decision durvalumab - head & neck cancer: Data read-out
Lynparza - ovarian cancer: Data read-out
CAZ AVI - serious infections: Regulatory decision (EU)
1. All growth rates and guidance are shown at constant exchange rates (CER) unless specified otherwise.
2. Total Revenue defined as Product Sales and Externalisation Revenue. For further details on the presentation of Total Revenue, see the announcement published by the Company in March 2015.
3. See the Operating and Financial Review for a definition of Core financial measures and a reconciliation of Core to Reported financial measures.
4. The performance shown in this announcement covers the nine and three month periods to 30 September 2015 (the year to date and the quarter respectively) compared to the nine and three month periods to 30 September 2014 (the prior year to date and the prior quarter respectively).
A conference call for investors and analysts, hosted by management, will begin at midday GMT today. Details can be accessed via www.astrazeneca.com/investors.
The Company intends to publish its full-year financial results on 4 February 2016.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Contacts at AstraZeneca
|Esra Erkal-Paler||UK/Global||+44 20 7604 8030|
|Vanessa Rhodes||UK/Global||+44 20 7604 8037|
|Ayesha Bharmal||UK/Global||+44 20 7604 8034|
|Jacob Lund||Sweden||+46 8 553 260 20|
|Michele Meixell||US||+1 302 885 2677|
|Thomas Kudsk Larsen||Oncology||+44 7818 524185|
|Eugenia Litz||RIA||+44 7884 735627|
|Nick Stone||CVMD||+44 7717 618834|
|Craig Marks||Finance||+44 7881 615764|
|Christer Gruvris||Consensus Forecasts||+44 7827 836825|
|Lindsey Trickett||Oncology, ING||+1 240 543 7970|
|Mitchell Chan||Oncology||+1 240 477 3771|
|Toll-Free||+1 866 381 7277|
Key: RIA - Respiratory, Inflammation & Autoimmunity, CVMD - Cardiovascular & Metabolic Disease,
ING - Infection, Neuroscience & Gastrointestinal
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