• Forskningsportföljen i sen fas ligger långt före tidsplanen tack vare ökad produktivitet inom R&D, accelererade program och en målinriktad affärsutveckling; 14 potentiella nya läkemedel finns i fas III eller är under registrering; vi har potential för 14–16 ansökningar och 8–10 godkännanden under 2015–2016.
• En branschledande immuno-onkologiportfölj med 13 pågående kombinationsprövningar och 16 under planering; förvärvet av Definiens kommer att bidra till att fler kliniska program påskyndas genom mycket exakt prediktiv och prognostisk biomarkörtestning.
• Ansökan i USA avseende AZD9291 förväntas komma under andra kvartalet 2015 som andrahandsbehandling av patienter med vissa former av icke-småcellig lungcancer.
• Våra fem tillväxtplattformar - Brilinta, diabetes, sjukdomar i andningsvägarna, tillväxtmarknaderna och Japan - står nu för mer än hälften av de globala intäkterna.
• Onkologi kommer bli vår sjätte tillväxtplattform; vi har flera potentiella ansökningar under 2015–2016; terapiområdet förväntas bidra med den största andelen ”pipeline-driven” intäktstillväxt och har potential att nå en fjärdedel av försäljningen 2023.
• Verksamheten håller på att utvecklas till att bli mer hållbar och lönsam; biologiska läkemedel står för 50 procent av portföljen, sannolikheten att nå framgångar och förbättra hållbarheten ökar med växande fokus på devices; en portföljbalans mellan primär- och specialistvård kommer att öka lönsamheten.
• Ett ramverk för disciplinerad kapitalallokering balanserar investeringarna inom forskning och utveckling med en progressiv utdelningspolicy, en värdeskapande affärsutveckling och en effektiv kapitalstruktur. Affärsmodellen omfattar värdeskapande genom partnersamarbeten och licensiering inom neurovetenskap och infektion.
• Vår spännande portfölj förväntas leda till en stark och jämn intäktstillväxt med årsintäkter på över 45 miljarder USD 2023
AstraZeneca ger idag en uppdatering för institutionella investerare och finansanalytiker över utvecklingen gentemot bolagets strategiska prioriteringar att uppnå ledarskap inom forskning och att återvända till tillväxt. Presentationen i London kommer att demonstrera AstraZenecas utsikter för tillväxt, snabb utveckling av pipeline och företagets vision om att leverera långsiktigt, hållbart värde för aktieägarna och patienter.
Pascal Soriot, koncernchef, AstraZeneca, säger: "Jag är mycket nöjd med de framsteg vi gör gentemot vår strategi. Vi har snabbt stärkt och accelererat vår forskningsportfölj, etablerat starkt momentum bakom våra tillväxtplattformar och skapar betydande värde för patienter och aktieägare.
"Vi har mer än fördubblat antalet potentiella läkemedel i våra sena utvecklingsportfölj sedan 2012 och vi är på god väg att återvända till tillväxt 2017. Driven av en mycket spännande portfölj av nya produkter, är onkologi på väg att bli AstraZenecas sjätte tillväxtplattform och spela en stor roll när det gäller att ta fram läkemedel som förändrar patienters liv, samtidigt som vi levererar långsiktig tillväxt.
"Vi bygger ett stabilt, tåligare och mer lönsamt företag. De konkreta resultat som levereras stärker vår övertygelse om att vi kommer att nå vårt mål om att leverera intäkter på över 45 miljarder USD 2023. "
Achieving scientific leadership
The progressive changes AstraZeneca has introduced in 2013 continue to fuel the transformation of its pipeline through scientific discoveries and accelerated clinical programmes. The investor presentation will highlight the strong progress towards achieving scientific leadership in the three core therapeutic areas - respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; and oncology.
AstraZeneca’s late-stage pipeline has transformed faster than anticipated, with 14 new molecular entities (NMEs) in Phase III or registration as compared to the original target of eight. Alongside this late-stage acceleration, the early-stage pipeline has also grown rapidly through a sharp focus on novel biology and technologies, providing a sustainable discovery engine behind all core therapeutic areas.
In 2015-2016, AstraZeneca is anticipating 12-16 Phase II starts, 14-16 NME and major line extension regulatory submissions and 8-10 NME and major line extension approvals. Near term delivery and longer term sustainability of the pipeline will be reinforced by shifting the focus from rebuilding the late-stage pipeline to supporting regulatory submissions and approvals, while continuing to transition high quality programmes to late-stage as rapidly as possible.
Respiratory, Inflammation and Automimmunity (RIA)
Significant progress is being made across the RIA pipeline, which includes six programmes in Phase III or registration. In particular, we are leveraging biologics in severe asthma and COPD and developing several promising assets in inflammatory and autoimmune disease areas such as dermatology, gout, systemic lupus and rheumatoid arthritis.
• AMAGINE-3 Phase III trial investigating brodalumab in patients with moderate-to-severe plaque psoriasis has met all primary and key secondary endpoints. Brodalumab, being developed in partnership with Amgen, showed superiority to Stelara (ustekinumab) in achieving total skin clearance (PASI 100) and met co-primary end-points against placebo. We anticipate regulatory submission for brodalumab for psoriasis in 2015.
• More than 15 abstracts were accepted at this week’s American College of Rheumatology annual meeting, demonstrating the continued progress in this area. Positive data presented across a range of investigational therapies include top-line results from CLEAR1 and CLEAR2, the pivotal Phase III clinical trials investigating the potential of lesinurad for the treatment of gout. EU and US submission is planned by the end of this year for use as combination therapy with the xanthine oxidase (XO) inhibitor, allopurinol. Late-breaking Phase IIb data on sifalimumab is also being presented, the first Phase II study to demonstrate efficacy in moderate to severe systemic lupus patients across multiple endpoints with an anti-interferon molecule, as well as data from a Phase IIb study for mavrilimumab as a first-in-class anti-GMCSFR antibody for the treatment of rheumatoid arthritis.
Cardiovascular and Metabolic Disease
AstraZeneca’s strategy in cardiovascular and metabolic disease focuses on ways to reduce morbidity, mortality and organ damage by addressing multiple risk factors across cardiovascular disease, diabetes and chronic kidney disease indications. This patient-centric approach is reinforced by science-led life cycle management programmes and technologies, including early research into regenerative methods.
• The diabetes strategy focuses on shifting the treatment paradigm towards early use of combination therapies, to help accelerate the achievement of goals for patients and potentially delay the progression of their disease.
• Forxiga is in Phase III development in type 1 diabetes.
• Regulatory submissions for saxagliptin and dapagliflozin fixed-dose combination are anticipated in the US and EU in early 2015.
• Roxadustat is currently in Phase III development and has the potential to become the first oral treatment for anaemia in patients with chronic kidney disease. First filing is expected in 2016. (China).
• The PARTHENON clinical development programme is assessing Brilinta’s potential for the long term treatment of patients with a prior myocardial infarction (MI), for the treatment of patients with peripheral arterial disease, ischaemic stroke and transient ischaemic attack, and for the prevention of cardiovascular events in patients with diabetes and coronary atherosclerosis.
• Top line results for the PEGASUS-TIMI 54 study, investigating Brilinta for the long-term prevention of atherothrombotic events in patients who suffered a heart attack one to three years prior to study enrolment, are expected in the first quarter of 2015.
• Investigational antibody MEDI2452 is in pre-clinical development as a potential reversal agent for Brilinta for use in rare emergency situations such as urgent surgery, or in the event of major bleeding, where doctors need the option to swiftly reverse the effects of oral antiplatelet agents.
• The European label for Brilique has been updated to highlight that its mechanism of action is different from the thienopyridine class of oral antiplatelets.
• The recently updated American Heart Association and American College of Cardiology guidelines for the management of non-ST-elevation acute coronary syndrome (NSTE-ACS) patients now recommend Brilinta as the preferred P2Y12 inhibitor for the management of NSTE-ACS patients who undergo an early invasive or ischaemia-guided strategy, or those who receive a coronary stent. This is the first time the guidelines have recommended one oral antiplatelet over another.
Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm. By 2020, we are aiming to bring six new cancer medicines to patients.
Our broad pipeline of next-generation medicines is focused on four main disease areas - breast, ovarian, lung and haematological cancers. These are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates (ADCs).
AstraZeneca has one of the most exciting and comprehensive immuno-oncology portfolios in the industry, with the potential to transform the way cancer patients are treated. In particular, the company is uniquely positioned to explore synergistic combinations of immunotherapies, both with each other and with our own highly targeted small molecules, supported by external collaborations.
Our firm commitment is to give patients the best chance of receiving the medicines suited for their particular needs and we have reinforced our personalised healthcare approach through recent partnerships with Illumina, Qiagen and Roche. The recent acquisition of Definiens will also help to accelerate further clinical programmes through precise predictive and prognostic biomarker testing.
• Positive CHMP opinion received for Lynparza (olaparib) in the EU and we anticipate US and EU approvals in the first quarter of 2015 (US PDUFA goal date is 3 January 2015), with further studies ongoing in breast, gastric, pancreatic cancers and promising early-stage activity in prostate cancer.
• US submission for AZD9291 as second line therapy for non-small cell lung cancer (NSCLC) is expected in the second quarter of 2015, just over two years since first patient dosing. AstraZeneca also plans to start a Phase III clinical trial for AZD9291 in the first line setting for NSCLC in the fourth quarter of 2014. AZD9291 has been granted Breakthrough Therapy designation, Orphan Drug and Fast Track status by the US FDA.
• Iressa received a label update in the EU allowing the use of circulating tumour DNA obtained from a blood sample for the assessment of EGFR mutation status where a suitable tumour sample is not available – the first in its class to achieve this. The technology will also be used for AZD9291.
• Rapid progress with anti-PD-L1, anti-CTLA-4 and novel approaches such as the OX40 biologics, combined with each other and small molecule assets, are opening up new opportunities to target multiple immune pathways ‘hijacked’ by tumour cells.
• 29 immuno-oncology combination trials are currently underway or planned. Of these, MEDI4736 is being studied in 12 combination trials, including ongoing Phase I development for a ‘triplet’ combination alongside BRAF and MEK inhibitors in melanoma, with results expected in first half of 2015. Combination studies of MEDI4736 with small molecule immuno-oncology assets (STAT3 and CXCR2) are expected to start in early 2015. Early stage studies are also planned for MEDI4736 in combination with ibrutinib, an oral Bruton’s tyrosine kinase inhibitor, for patients with haematological cancers.
• MEDI4736 is currently being investigated in Phase II as a monotherapy in head and neck cancer, and in Phase III as a monotherapy in NSCLC, including in adjuvant setting for NSCLC through a global study launched last week by the NCIC Clinical Trials Group. Phase III trials of MEDI4736 in combination with tremelimumab in both of these cancer types are scheduled to start in early 2015.
• The fast developing mid-stage small molecule oncology pipeline has a strong focus on tumour drivers and resistance, as well as DNA damage response.
Return to growth
As we set out in March 2013, AstraZeneca’s strategy of returning to growth focuses on building key growth platforms, accelerating growth through business development and transforming the business shape through specialty care and biologics. Since then, we have made strong progress against these priorities by maximising the potential of the assets in our hands today, leveraging our global scale, and investing in core therapeutic growth areas as well as key geographies.
Our current business is focused in the three core therapeutic areas where we have our development and commercial expertise. Our marketed brands in respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; and oncology are collectively delivering 69 percent of total revenues. These are maximised through AstraZeneca’s global scale, including a strong presence in the Emerging Markets.
The five current growth platforms – Brilinta, diabetes, respiratory, Emerging Markets and Japan – are sustaining near-term growth as we progress towards the long-term revenue targets we previously set out. As highlighted in our third quarter and nine months financial results presentation on 6 November 2014, these platforms now account for more than half of AstraZeneca’s global revenues, helping to navigate a period during which some of our established products are scheduled to lose exclusivity. We anticipate that oncology will become the sixth growth platform in the mid-term.
AstraZeneca is making use of targeted business development to reinforce our therapeutic areas while supporting our long-term pipeline aspirations. In the past eighteen months, there has been a more intense focus on early stage academic and biotech alliances by our small molecule and biologics biotech units. In addition, we continued to strengthen the pipeline, focusing predominately on the three core therapy areas, while we will seek partnerships and bolt-on acquisitions to support the late-stage and on-market portfolio to accelerate revenues.
Strategic transactions including the acquisition of Bristol Myers Squibb’s share of the diabetes alliance and the rights to Almirall’s respiratory portfolio are helping to reinforce our core therapeutic areas.
Our business model includes value creation through partnerships and licensing from the strong science in our neuroscience and infection pipeline. This is exemplified by the alliance with Eli Lilly to co-develop and commercialise our BACE inhibitor, AZD3293, and the funding support for breakthrough infection medicine MEDI4983 from the Innovative Medicines Initiative. The recently announced divestment of Myalept to Aegerion is another example of additional value creation through partnerships, licensing or divestments.
In parallel with the pipeline transformation, and the company’s global scale and commercial excellence, AstraZeneca’s business shape is changing to become more sustainable, durable and profitable. Biologics now account for 50 percent of our pipeline, increasing the probability of success and enhancing the longevity of our assets. A greater focus on innovative delivery devices offers choice to patients while ensuring durability of our products. Overall, the growing balance in our portfolio of primary and specialty care products will boost profitability.
Making AstraZeneca a great place to work
AstraZeneca continues to drive its cultural transformation and operational simplification to support our strategic goals of achieving scientific leadership and returning to growth. Our efforts to nurture a strong culture of innovation and enterprise are having a positive impact across the organisation. Results from a recent employee survey reflect the progress we have made in engaging our employees and gaining support for our science-led strategy. The simplification of management structure has helped ensure a sharper focus, removed unnecessary barriers and further accelerated decision making, increasing our productivity.
The changes we have made to our research and development footprint around three strategic centres have increased our proximity to bioscience clusters in the US and Europe. These enhancements are making it easier for our researchers to collaborate with external partners and with each other to leverage our small and large molecule capabilities, contributing to the pace of pipeline development and targeted collaborations.
Robust financials and disciplined capital allocation are delivering shareholder value
AstraZeneca recently reported a third consecutive quarter of revenue growth and increased revenue and Core EPS guidance for full year 2014.
The company has continued to invest in research and development, maximising the impact of new product launches and undertaking strategic business development. As previously stated, we expect 2017 revenues to be broadly in line with those of 2013 (at constant exchange rates) as our key growth platforms continue to deliver and the late-stage NMEs move to approval and launch.
Looking beyond 2017, our disciplined value creating framework, alongside one of the most exciting pipelines in the industry, is expected to drive strong and consistent revenue growth, leading to annual revenues in excess of $45 billion by 2023. Furthermore, operating leverage is expected to result in core earnings growth in excess of revenue growth during this period.
As a result of this growth, AstraZeneca is poised to generate significant operating cash flow over the coming decade and the company is committed to allocating capital in a balanced way through its disciplined framework. We will continue to invest in R&D, focused on three core therapeutic areas, in order to realise the full potential of our attractive pipeline. In line with our business model, we will create value from the assets in our pipeline through partnerships and licensing, in particular in neuroscience and infection.
AstraZeneca’s renewed R&D productivity and development of the late-stage pipeline has already generated significant value for AstraZeneca shareholders. We anticipate that the pace of value creation will increase as the pipeline continues to evolve, while our exciting early stage research provides a sustainable discovery engine. The company will retain the flexibility to invest selectively in value-enhancing and strategic business development as opportunities arise.
AstraZeneca remains committed to its progressive dividend policy, returning $3.5 billion to shareholders in 2013. We anticipate this dividend policy, alongside our commitment to an efficient capital structure, will underpin an attractive total shareholder return proposition as the Company returns to growth.
NOTES TO EDITORS
AstraZeneca Investor Day
AstraZeneca’s Investor Day briefing for institutional investors and financial analysts will take place from 12:30 GMT / 07:30 EST to 18:30 GMT / 13:30 EST. Details of the webcast and how to access the presentations are available on www.astrazeneca.com/Investors and info.astrazenecaevents.com.
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. For more information please visit: www.astrazeneca.com
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