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Shire Global

Investor Relations

Our Strategy

OUR STRATEGY

Our strategy is to grow and create long-term value by being the leading global biotech company focused on developing and delivering high impact medicines for rare diseases. To this end, we work together to excel across four key strategic drivers: growth, innovation, efficiency and people.

Growth

Growth

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

Progress in 2016

  • Completed acquisitions of Dyax and Baxalta, adding rare disease assets to Shire’s Genetic Diseases franchise and establishing franchises in Hematology, Immunology, and Oncology
  • Enhanced size and value of our portfolio of commercial products to drive Shire revenue to $11.4 billion (+78 percent compared to 2015). Global sales footprint expanded to 109 countries, with commercial operations in 68 countries
  • Received approvals and launched XIIDRA (U.S.; Dry Eye Disease), CUVITRU (U.S., Europe; primary immunodeficiency), ONIVYDE (Europe; 2nd line metastatic pancreatic cancer), and VONVENDI (U.S., von Willebrand Disease)
  • New indications, geographies, and patient populations for ADYNOVATE/ADYNOVI, LIALDA, and VYVANSE
  • Expansion of Cambridge, MA operations as a rare disease innovation hub

Priorities for 2017

  • Expand therapeutic area leadership by enhancing commercial capabilities, increasing our global footprint and broadening our portfolio of best-in-class products
  • Focus on commercial execution and new product launches, including geographical expansions to continue the building of global brands across our seven franchises
  • Effectively execute our late stage clinical development pipeline to support future growth

Key Performance Indicators

  • Net product sales, Non GAAP cash generation
Innovation

Innovation

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

Progress in 2016

  • Expanded pipeline to roughly 40 programs in the clinic, the largest in Shire’s history, with about 20 in the later stages of development (in registration, in Phase 3 or ready to enter Phase 3)
  • Resubmitted SHP465 (U.S.; ADHD) to FDA, decision expected on or around June 2017
  • Achieved 2 Breakthrough Therapies designations (SHP621 for eosinophilic esophagitis; SHP625 for progressive familial intrahepatic cholestasis type 2), 1 Fast Track designation (SHP626; nonalcoholic steatohepatitis)
  • Strengthened gastrointestinal disease pipeline via in-licensing of SHP647, a Phase 3-ready asset for inflammatory bowel disease (“IBD”)

Priorities for 2017

  • Submit regulatory filings for VONVENDI (EU; von Willibrand disease), FIRAZYR (Japan; hereditary angioedema), VYVANSE (ADHD; Japan), and XIIDRA (EU; dry eye disease)
  • Drive execution excellence on our late stage clinical development portfolio to support future growth, including Phase 3 readouts for SHP643 (hereditary angioedema/HAE), SHP609 (Intrathecal delivery for Hunter’s Disease), and topline data supporting ONIVYDE submission in Japan
  • Supplement our early-stage pipeline to support sustained future growth

Key Performance Indicators

  • Number and potential value of products in clinical development pipeline
Efficiency

Efficiency

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

Progress in 2016

  • Exceeded goals and benchmarks related to speed and synergy capture in the Baxalta integration. Mid-year, increased initial estimates on total synergy capture to $700 million+ by Year 3
  • Aligned on combined approach for commercial operations, market access, and patient services, while beginning international commercial site consolidations and initiating a manufacturing network optimization program
  • Decisions taken to exit Biosimilars and streamline Oncology portfolio obtained in the Baxalta acquisition, to maintain focus on high value rare and specialty conditions

Priorities for 2017

  • Drive synergies and profitability through global scale and lean general and administrative (“G&A”) model
  • Build on progress of Baxalta integration to date
  • Continue optimization of portfolio
  • Reduce leverage

Key Performance Indicators

  • Non GAAP EBITDA margin, Non GAAP ROIC, Non GAAP net debt/Non GAAP EBITDA ratio
People

People

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

Progress in 2016

  • Grew organization to approximately 24,000 employees globally, following integrations of Dyax and Baxalta, while maintaining favorable metrics on employee retention and morale
  • Rolled out new organizational structure, incorporating top talent from Shire, Baxalta, and Dyax
  • Served our patients and communities through events such as Shire’s Global Day of Service, in which more than 6,500 Shire employees volunteered over 25,000 hours in 150 locations around the world
  • Announced a multi-year partnership with SeriousFun Children’s Network, supporting 16 camps around the world for children and their families living with serious illnesses. The partnership allows for a variety of engagement opportunities, strengthening our deep commitment to the patients and families who are affected by rare diseases. In 2016, Shire employees donated over 5,000 hours of volunteer time with SeriousFun camps, globally

Priorities for 2017

  • Continue to support and enhance an entrepreneurial, patient-focused culture
  • Retain the best talent and practices.

Key Performance Indicators

  • Number of employees

Business Model

Our way of leading in rare diseases

We maintain a sharp focus on rare diseases to deliver high impact for patients, sustained corporate growth and increased value for society.

We are focused on developing and delivering life-changing medicines for underserved patients with rare diseases

We are sharply focused on patient populations with extraordinarily high unmet needs — often, their conditions are not well understood, even within the healthcare community, and there may be few or no effective therapies. We bring unique expertise and innovative technologies to select therapeutic areas where we see tremendous opportunity to enhance patients’ lives and establish a durable leadership position in the industry. While rare conditions form the core area of highest emphasis, we often see additional opportunities to apply our expertise and therapeutic area leadership to certain highly specialized, non-rare indications where we see the opportunity to bring innovation to enable patients to live fuller lives.



We build a portfolio of products through a combination of focused internal research and development, collaborations with leading institutions, and strong business development capabilities

We begin by identifying gaps in current medical care where patients with serious illnesses are significantly impacted by either the lack of effective therapies or shortcomings in the available treatments. We listen carefully to patients, advocacy groups, and our network of leading clinicians to deeply understand patient needs. We seek to match these opportunities with promising scientific innovations which offer the potential to deliver a meaningful therapeutic advance. We are agnostic to the specific technologies involved and where they originate — we are exclusively focused on identifying the most promising ways to address patient needs. Frequently, this mindset leads us to collaborate and partner with leading research institutions and emerging “start-up” companies with novel therapeutic approaches. We employ a sophisticated business development capability that enables us to continually survey the landscape, identify promising approaches, and rapidly strike agreements to advance these potential next-generation therapies. We then apply our specialized, world-class development and commercialization resources to rapidly deliver these innovations to patients

As the leader in rare diseases, we invest in and develop the unique capabilities required for successful development and commercialization of high-impact products

We have built a broad constellation of unique, industry leading capabilities that allows us to maintain our leadership in rare diseases, and that positions us as the partner of choice in this area. For example, within our R&D organization we have specialized expertise that enables us to address the challenges of developing new medicines in rare disease indications, such as recruiting hard-to-find patients, navigating ill-defined current standards of treatment, and pioneering unprecedented regulatory pathways. Similarly, once new therapies are approved, we then apply sophisticated approaches to increase diagnosis rates, support patients as they initiate therapy, and productively engage with patients, leading treatment centers and advocacy organizations. Our nimble global supply network is also tailored to the unique challenges of reliably delivering potentially life-saving rare disease therapies to often diffuse global patient populations.

Our scale and focus specifically on rare diseases enables us to invest deeply in these capabilities, with high impact. We apply our expertise and skills to the task of bringing new, cutting-edge therapies for conditions where, in many cases, no therapy has existed. Combined with our sharp focus on execution, we ensure that the most underserved patients around the world have access to the critical therapies they need.



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