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Shire Global

Investor Relations

Our Strategy

We are committed to becoming the leading global biotech company focused on rare diseases. To this end, we work together to excel across four strategic drivers: growth, innovation, efficiency and people.

Growth

Growth

We drive performance from our currently marketed products to optimize revenue growth and cash generation.

Progress in 2015

  • Successful US launch of VYVANSE for adults with moderate to severe BED, outperformed the US adult market. Vyvanse grew 19% over the prior year.
  • NATPARA and GATTAX/REVESTIVE launches have shown early promise.
  • LIALDA continued to gain market share and now represents 36% of the US 5-ASA market (2014: 33%).
  • Internationally, we achieved 25 in-market launches.
  • Continued to drive growth through international expansion, with Shire medicines now available in 72 countries and operational presence in 50 countries (2014: 68 and 34 countries respectively).
  • Our HAE portfolio, CINRYZE and FIRAZYR, grew 23% and 22%, respectively (2014: n/a and 55% respectively).

Priorities for 2016

  • Continue to prioritize investment in our future growth drivers.
  • Prepare for approval and launch of lifitegrast (SHP606), which has potential to be the only product approved in the US in the past decade indicated for treatment of signs and symptoms of DED.
  • Continue to expand access to our therapies around the world.

Key Performance Indicators

  • Net product sales $6.1bn (2014: $5.8bn)
  • Non GAAP cash generation1 $2.4bn (2014: $2.4bn)

1 This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Cash provided by operating activities (FY 2015: $2,337m, FY 2014: $4,228m).
For a reconciliation of Non GAAP financial measures to the most directly comparable measure under US GAAP, see pages 159 to 163 of our 2015 Annual Report.

Innovation

Innovation

We build our future assets through both R&D and business development to deliver innovation and value for the future.

Progress in 2015

  • Established the strongest pipeline in Shire’s 30-year history, with 29 clinical development programs, including 14 under regulatory review, in Phase 3 or planned to enter Phase 3 in 2016.
  • Selected Phase 3 programs include SHP620 (MARIBAVIR) for CMV infection in transplant patients; SHP621 for Eosinophilic Esophagitis and SHP609 for Hunter syndrome-intrathecal delivery (phase 2/3), all in areas of high unmet medical needs and high concern to patients.
  • Received Fast Track designation from the FDA for SHP607 for the prevention of ROP and SHP609 for Neurocognitive Decline associated with Hunter syndrome.
  • Partnered with Cincinnati Children’s Hospital and Foundation Fighting Blindness to collaborate on research into rare diseases.

Priorities for 2016

  • Continue to build and advance our pipeline of innovative therapies.
  • Continue to forge research collaborations and partnerships to explore new treatments for rare diseases.

Key Performance Indicators

  • Number of products in pipeline 29 (excluding preclinical assets) (2014: 27)
Efficiency

Efficiency

We operate a lean and agile organization and reinvest for growth.

Progress in 2015

  • Focused on consolidating and building our US operational headquarters in Massachusetts.
  • Took important steps in strengthen our manufacturing capacity to boost the production of CINRYZE.
  • Initiated plans to evolve our technical operations operating model to ensure dedicated focus on biologics and on small molecules.
  • Maintained responsible environmental practices in the supply chain, and overall environmental efficiency resulting in being named #2 “Greenest” company in the world by Newsweek magazine.
  • Completed integrations of NPS Pharma and ViroPharma Incorporated (“ViroPharma”).

Priorities for 2016

  • Continue to operate a lean and agile organization.
  • Look critically at how we work and where we can improve our core processes and systems to do things better and faster.

Key Performance Indicators

  • Non GAAP EBITDA margin1,2 43% (2014: 44%)
  • Non GAAP adjusted ROIC2 10.3% (2014: 14.7%)

1 This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Income margin (FY 2015: 20%, FY 2014: 57%).

2 For a reconciliation of Non GAAP financial measures to the most directly comparable measure under US GAAP, see pages 159 to 163 of our 2015 Annual Report.

People

People

We foster a high-performance, patient-focused culture where we attract, retain and promote the best talent.

Progress in 2015

  • Filled more than 2,000 roles comprised of net new employees as well as replacement roles resulting from final stages of One Shire transition and consolidation of US operational HQ in Lexington, MA.
  • Held our first ever Global Day of Service, with more than 1,700 colleagues donating 8,000 volunteer hours in 20 countries.
  • Integrated our new colleagues from ViroPharma and NPS Pharma.
  • Continued to strengthen our high-performance, patient-focused culture.
  • Flemming Ornskov, CEO, named one of the 100 best-performing CEOs in the world by the Harvard Business Review.

Priorities for 2016

  • Improve employee wellbeing and expand employee engagement in community programs.
  • Continue to build and strengthen our culture.
  • Integrate colleagues from Dyax with the close of the acquisition.

Key Performance Indicators

  • Sales per employee $1.1m (2014: $1.2m)
  • Number of employees 5,548 (2014: 5,016)

Business Model

We have a unified global business model designed to enable us to excel clinically and commercially to create value.

Organized for success

In pursuing our purpose of enabling people with life-altering conditions to lead better lives, we are transforming ourselves into a leading global biotech developing and delivering best-in-class therapies for patients with rare and specialty conditions.

Our culture plays a key part in our success. We have a strong patient-focused, performance-based culture:

  • We have the courage to lead the way – to anticipate and act on what’s next.
  • We are agile and adaptable, shaping a better future for patients.
  • We keep our promises.
  • We fearlessly innovate to address unmet patient needs.
  • We do the right thing in the right way.

Our business model is also fundamental – supporting our focus on our four strategic drivers: growth, innovation, efficiency and people.

Inputs

  • Our talented, passionate and committed people.
  • Our unique high performance, patient-focused culture.
  • Our experienced, dynamic leadership.
  • Our nimble and efficient manufacturing and sales networks.
  • Our ongoing reinvestment.
  • Our strong governance.

Investment in Non GAAP R&D1 in 2015

$884m

Our in-house R&D focuses on advancing our pipeline of innovative treatments for unmet needs with a strong emphasis on rare diseases.

1 This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is R&D (FY 2015: $1,564m, FY 2014: $1,068m).

Our business model

  • Acquire and in-license products that address high unmet needs.
  • Reinvest in targeted in-house R&D.
  • Partner with leading research hospitals, academic and non-profit organizations.
  • Use innovative, state-of-the-art manufacturing and partner with manufacturing organizations.
  • Apply a tailored go-to-market model.
  • Provide dedicated support to physicians and caregivers.

Acquisitions in 2015

3 complete acquisitions

2 proposed acquisitions

We fuel our growth and value creation through the targeted acquisition of new companies, licensing agreements and partnerships.

Value created

  • Reinvestment in R&D.
  • Rewarding careers for employees.
  • Significant returns to shareholders.
  • Greater awareness and understanding of rare diseases.
  • Life-changing therapies for patients, their families and treating physicians.
  • Wider benefits to society.

Non GAAP EBITDA1

$2.9bn

Our business unit teams focus on commercial excellence across Rare Diseases, Neuroscience, Gastrointestinal & Internal Medicine and Ophthalmics.

1 This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net Income (FY 2015: $1,303m, FY 2014: $3,046m).
For a reconciliation of Non GAAP financial measures to the most directly comparable measure under USGAAP, see pages 159 to 163 of our 2015 Annual Report.


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