Year in review

Our growth strategy is to focus on developing and marketing innovative specialty medicines.

January

  • Rare Diseases pipeline enhanced with the acquisition of Lotus Tissue Repair, which is developing a protein replacement therapy for the treatment of Dystrophic Epidermolysis Bullosa
Lotus Tissure Repair

February

  • ELVANSE receives UK marketing authorization, providing a new option for the treatment of ADHD in children and adolescents in the UK
  • VPRIV wins first ever 'novel treatment award' from Lysosomal Disease Network at the 9th World Symposium
John Neeley, Head of Global Market Access
Dominic Blakemore,
announced as Non-Executive Director

March

  • Late-stage pipeline enhanced with the acquisition of Premacure, which is developing a Phase 2 protein replacement therapy for the prevention of ROP
  • SARcode acquisition brings Shire a new Phase 3 compound being investigated for Dry Eye disease

April

  • Phase 2 studies commence evaluating VASCUGEL in patients with end-stage renal disease undergoing Arteriovenous Access Creation for Hemodialysis
  • Flemming Ornskov appointed Chief Executive Officer

May

  • VYVANSE capsules approved in the US for maintenance treatment in children and adolescents with ADHD
  • Flemming Ornskov, MD, CEO sets out his strategy for Shire’s future and outlines a re-alignment of its business structure to drive future growth and innovation
  • Bill Ciambrone appointed Head of Technical Operations
John Neeley, Head of Global Market Access
Flemming Ornskov,
Chief Executive Officer

June

  • Mark Enyedy appointed as leader of Internal Medicine Business Unit

July

  • Kim Stratton appointed as Head of International Commercial

August

  • Marianne Jackson appointed as Head of Global Commercial Operations

September

  • Perry Sternberg appointed as Head of the Neuroscience Business Unit
  • John Neeley appointed as Head of Global Market Access
SARcode bioscience

October

  • Fourth annual scholarship program for individuals with ADHD launched
  • Dominic Blakemore appointed as non-executive director
  • Phil Vickers appointed as Shire’s Head of Research and Development

November

  • Positive top-line results shown for VYVANSE capsules in adults with Binge Eating Disorder
  • ViroPharma acquisition announced to strengthen Rare Diseases portfolio

December

  • OPUS-2 top-line results, a Phase 3 study investigating the use of Lifitegrast (SHP 606) (5.0% ophthalmic solution) in adults with Dry Eye disease

Welcome to Shire

At Shire we put patients with specialized conditions at the heart of our business. We are dedicated to transforming their lives around the world by developing and marketing innovative treatments that meet their needs.

We live up to this commitment through our unified business – One Shire. Working together as one, we strive for success characterized by innovation, focus, excellence, growth and change for the better.

  • 2013 Annual Report

    Download the full Shire 2013 Annual Report pdf.

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  • Year in Review

    View the highlights of our year.

    View the full Year in Review

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  • Vision
  • Strategy
  • In-linePipelineInline Pipeline

    Excellence
    Innovation
    Support
    Governance
    Culture

Strategy and business model

We are focused on growing Shire by developing and marketing innovative specialty medicines that address significant unmet patient needs.

Our vision

Our vision is to transform the lives of people around the world whose health is impacted by rare and other specialized conditions, through providing innovative treatments.

We bring this vision to life through our strategy and business model.

Our strategy

Our strategy describes how we will achieve our vision.

Our strategy is to grow our business and deliver value to our stakeholders by focusing on significant unmet patient need in specialist areas and providing more innovative treatments to more patients.

To deliver this, we:
  • Serve patients with high unmet needs in select, commercially attractive specialty therapeutic areas.
  • Drive optimum performance of our In-line, marketed products – to serve patients today.
  • Build our Pipeline of innovative treatments through both Research and Development ("R&D") and Business Development activities - to enable us to serve patients in the future.
  • Concentrate our R&D capabilities on the development of innovative specialist medicines.
Our business model

We implement our strategy through our business model. It is our structure for success and drives our growth.

During 2013 we unified our business - our One Shire model has created a simple structure and focused efficient organization that is scalable for growth.

  • In-line

    Our currently marketed products to meet the needs of patients today and maximize revenue growth.

  • Pipeline

    The innovative products we are developing to meet patients’ significant unmet needs.

  • Commercial excellence

    We have four business units that focus exclusively on the commercial execution of our In-line products in our specialist therapeutic areas: Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine. This ensures we provide innovative treatments, and service the needs of our customers and patients, as efficiently as possible.
  • Innovation

    We have moved to a single R&D organization that focuses on developing our pipeline of innovative treatments to address unmet patient needs. This ensures we prioritise the treatments we focus on to ensure they have the highest chance of clinical success and are aligned with our priority therapeutic areas and potential new areas such as ophthalmology and hematology/oncology. Our early stage research is primarily focused on rare diseases.

    Our growth is also fueled by the acquisition of new compounds and marketed products. Shire's global Business Development team searches the industry for value-added therapeutics that fit our strategic focus and address patients’ unmet needs. The team is engaged in conversations with scientists and entrepreneurs all around the world, while collaborating daily with commercial and R&D experts throughout Shire.

  • Support

    Our support functions, including Technical Operations, are unified across the business to ensure we support our In-line and Pipeline activities as efficiently and effectively as possible.

  • One way of working

    We lead our business through our Executive Committee which, supported by our In-line and Pipeline Committees, ensures we allocate resources and make decisions across the enterprise in the best interests of One Shire, our patients, shareholders and other stakeholders.

    Our unified way of working means we can quickly adapt to focus our resources where the greatest opportunities exist.

  • One culture

    We have a clear and strong patientfocused culture where we all strive to be BRAVE:

    Bold: We have the courage to lead the way

    Resilient: We are agile and adaptable to meet the changing needs of our stakeholders

    Accountable: We deliver on our promises to all of our stakeholders

    Visionary: We fearlessly innovate to address unmet patient need

    Ethical: We do the right thing, in the right way Our culture comes to life through our employees who together form One Shire. We value and invest in our employees to ensure they have the capabilities and support to implement our strategy, achieve our vision and deliver value to our patients, payors and shareholders.

  • 2013 Achievements

    May

    VYVANSE capsules approved in the US for maintenance treatment in children and adolescents with ADHD.

    View the full Year in Review

    View the full Year in Review

At a glance: In-line

Shire delivered double digit product sales growth.

  • Rare Diseases
  • Neuroscience
  • Gastrointestinal
  • Internal Medicine
  • ADHD
    $1,228m 2012: $1,030m

    VYVANSE product sales grew strongly (+19%) in 2013 primarily as a result of price increases as well as higher prescription demand, due to growth in the US ADHD market (+6%) and VYVANSE’s share of that market.

  • Hunter syndrome
    $546m 2012: $498m

    Reported ELAPRASE sales growth (+10%) was driven by an increase in the number of patients on therapy. The increase in ELAPRASE sales between Q3 and Q4 of 2013 was partly driven by the timing of certain large orders from markets which order less frequently.

  • Ulcerative colitis
    $529m 2012: $400m

    The growth in product sales for LIALDA/MEZAVANT (+32%) in 2013 was primarily driven by higher market share in the US, the effects of which were partially offset by higher sales deductions in 2013 as compared to 2012.

  • Fabry disease
    $468m 2012: $497m

    REPLAGAL sales were down 6% compared to 2012 (down 4% on a CER basis) as sales in 2013 were impacted by foreign exchange, pricing pressure (primarily in Europe) and slightly lower volumes due to the return of competition to the Fabry market.

  • ADHD
    $375m 2012: $429m

    ADDERALL XR product sales decreased 12% in 2013 as a result of higher sales deductions, partially offset by the effect of higher stocking in 2013 compared to 2012.

  • Gaucher disease
    $343m 2012: $307m

    Reported VPRIV sales growth of 12% was driven by an increase in the number of patients on therapy.

  • ADHD
    $335m 2012: $288m

    INTUNIV product sales were up 16% compared to 2012, driven by growth in US prescription demand (up 9% compared to 2012), together with price increases. These positive factors were partially offset by higher sales deductions in 2013 compared to 2012.

  • Ulcerative colitis
    $281m 2012: $266m

    PENTASA product sales were up 6% as the benefit of price increases was partially offset by higher sales deductions in 2013 as compared to 2012.

  • Hereditary Angiodema
    $235m 2012: $116m

    FIRAZYR sales growth (+102% compared to 2012) was primarily driven by the US market, where we continue to see both good growth in new patients and increased levels of repeat usage by existing patients.

Our growth strategy is to focus on developing and marketing innovative specialty medicines
  • 2013 Achievements

    March

    SARcode acquisition brings Shire a new Phase 3 compound being investigated for Dry Eye disease.

    View the full Year in Review

    View the full Year in Review

At a glance: Pipeline

Building our future assets through both R&D and business development to deliver innovation and value.

Strong innovative pipeline

Our current pipeline has a very promising range of late stage assets and we will seek to add to these through business development.

  • 2013Discovery
    & preclinical
    • Discovery and preclinical assets focussed on rare diseases
  • Phase
    One
    • SHP611SHP611 is currently in a Phase 1/2 clinical trialMLD
    • CINRYZE IV(low vol)
      HAE Prophylaxis
    • CINRYZE SCSubcutaneous formulationHAE Prophylaxis
    • VP20629Friedreich’s Ataxia
  • Phase
    Two
    • LDXLisdexamfetamine dimesylate, active ingredient in VYVANSE/ELVANSE(Japan) ADHD
    • SHP602(FerroKin)
      Iron overload
    • SHP613Acute Vascular Repair
    • SHP607(PREMIPLEX®)
      Prevention of ROP
    • SHP609Hunter CNS
    • SHP610SHP610 has completed its Phase 1/2 clinical trial and preparation is underway for a Phase 2b trialSanfilippo A
    • MARIBAVIRCMV in transplant patients
  • Phase
    Three
    • SHP606(Lifitegrast) Dry eye disease
    • LDXLisdexamfetamine dimesylate, active ingredient in VYVANSE/ELVANSEBED
    • FIRAZYRACE inhibitor-induced AE
    • INTUNIV®(EU) ADHD
    • SHP555 (US)Discussions are planned with the FDA to determine potential clinical development pathwaysChronic Constipation
    • INTUNIV®(Japan) ADHD
  • Registration
    & Phase Four
    • XAGRID®(Japan)
      Essential Thrombocythaemia
    • VPRIV(Japan) Gaucher

Multiple pipeline milestones expected

  • 2014
    • INTUNIV(EU) MAA submission
    • VYVANSEHead to Head versus Concerta Phase 4 data
    • SHP602Phase 2b iron overload headline data study 203
  • 2015
    • MARIBAVIRPhase 2 headline data
    • SHP607 ROPPhase 2 headline data
    • SHP613 AVFPhase 2 headline data
  • Innovation

    Innovation is fundamental to our business, including development of new treatments for unmet patient needs...

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    Read some of our strories
  • Excellence

    From the way we work together to the distinctive qualities of our treatments, we strive for excellence throughout our business...

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    Read some of our strories
  • Focus

    Our strategic focus is on providing innovative treatments for patients with rare and other specialized conditions...

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    Read some of our strories
  • Growth

    We aim to deliver significantly above average industry growth levels...

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    Read some of our strories
  • Change

    We know that we have to always embrace change to stay ahead and deliver our growth ambitions...

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    Read some of our strories