Financial results for Q1 2015 support reiterated 2015 guidance.
- Total Revenue (defined as Product Sales and Externalisation Revenue1) grew by 1% at constant exchange rates2 to $6,057m (Q1 2014: $6,460m)
- Core earnings per share (EPS) declined by 3% to $1.08 as we maintain our investment in scientific leadership
- Reported Operating Profit grew by 15% to $933m (Q1 2014: $836m)
Achieving scientific leadership: Delivery of a focused, accelerated and science-based pipeline continues with strong news flow; on track to deliver 7-8 potential NME submissions in 2015-16.
- 13 NMEs in Phase III or registration.
- US submission acceptance for lesinurad in gout and saxagliptin/dapagliflozin in diabetes.
- Positive Phase III data for PT003 in chronic obstructive pulmonary disease.
- Positive Phase IIb data for anifrolumab in lupus and Phase III investment decision.
- Positive Phase III data for Brilinta in patients with a history of heart attack and regulatory submissions in the US and EU.
- Latest data for AZD9291, in non-small cell lung cancer, showed strong patient benefit of 13.5 months progression-free survival.
- Orphan-Drug Designation granted by US FDA for tremelimumab in mesothelioma and selumetinib in uveal melanoma.
- Fast-Track designation granted by US FDA for MEDI4736 in non-small cell lung cancer and MEDI8897 for treatment of respiratory tract infection caused by the RSV virus in young children.
Return to growth: Growth platforms grew by 13% in the quarter, representing 56% of Total Revenue.
- Brilinta/Brilique: 45% growth in the quarter, supported by publication of encouraging PEGASUS data at the ACC conference in March.
- Diabetes: grew by 47%, supported by particularly good growth for Farxiga/Forxiga.
- Respiratory: the respiratory franchise grew by 7%, with stable Symbicort sales and strong Pulmicort performance.
- Emerging Markets: grew by 18% in the quarter, supported by 28% growth in China, where respiratory sales were up by 39%.
- Japan: sales were down 2% in the quarter, due to the final effects of the biennial price cuts.
Externalisation focus is accelerating in line with our business model, creating additional value for patients and shareholders from the strong science in our pipeline.
- Co-commercialisation agreement with Daiichi Sankyo in the US for Movantik, which launched in March for opioid induced constipation; deal entailed $200 million in upfront externalisation revenue included in Q1 2015 Total Revenue.
- Strategic collaboration with Celgene to develop our immuno-oncology (IO) portfolio in blood cancers.
Pascal Soriot, Chief Executive Officer, commenting on the results said:
"Our encouraging performance in the quarter supports our full year guidance. Total Revenue grew by 1%, with the growth platforms representing 56%, after particularly strong results in Emerging Markets and with Brilinta/Brilique. Our co-commercialisation agreement for Movantik in the US was a good illustration of how we will bring important medicines to patients and externalisation value to our shareholders.
"Our pipeline progressed well in each of our therapy areas. Highlights included the positive top-line results from the Phase III PINNACLE programme for our respiratory medicine PT003 and data from the PEGASUS study for Brilinta/Brilique in cardiovascular disease. We received two submission acceptances for new medicines, two FDA Orphan-Drug and two Fast-Track designations. We look forward to presenting data through the year.
"We also continued to reinforce our Oncology franchise and now have 72 trials underway, including 31 in immuno-oncology. The latest AZD9291 data, which showed strong clinical benefit of 13.5 months progression-free survival, and the Fast-Track designation by the FDA for MEDI4736, both for patients with lung cancer, illustrate the rapid progress we are making in this area. Our strategic alliance with Celgene, a leader in haematology, will maximise the potential of our immuno-oncology assets in the very important haematology indications and our collaboration with Innate Pharma will further strengthen our immuno-oncology franchise."
We anticipate continued strong news flow in our science-led pipeline through the year, including:
- Forthcoming regulatory submissions for AZD9291 in non-small lung cancer, cediranib in ovarian cancer and brodalumab in psoriasis.
- Forthcoming regulatory decisions for Iressa in non-small cell lung cancer, Brilinta/Brilique in patients with a history of heart attack, lesinurad in gout and saxagliptin/dapagliflozin in Type II diabetes.
2015 Guidance:
The Company reiterates the guidance provided on 6 March 2015:
- Full Year 2015 Total Revenue is expected to decline by mid single-digit percent
- Core EPS is expected to increase by low single-digit percent
1For further details on the presentation of Total Revenue, see the announcement published by the Company on 6 March 2015.
2 All growth rates are shown at constant exchange rates.
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