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Annual Report 2016

Annual Report 2016

The global leader in rare diseases

Annual Report 2016

Chairman’s review

A year of transformation and growth

Chairman’s review

A year of transformation and growth

"The patient is at the center of everything we do at Shire. This drives how we discover, develop and deliver new medicines, and guides how we interact and support our patient communities."

Susan Kilsby
Chairman

Chief Executive Officer’s review

Sharp focus
High impact

Chief Executive Officer’s review

Sharp focus
High impact

"We’ve long believed we have a unique opportunity to champion underserved patient communities by placing them at the center of all we do. 2016 was a standout year as Shire became the global leader in rare diseases — a position we are determined to build on as we go forward."

Flemming Ornskov, MD, MPH
CEO

Our business model

Our way of leading
in rare diseases

Learn More

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

Specialty and rare disease therapies

1 Preclinical program.
2 Subject to regulatory approval.

Our strategy

Focusing on four
key strategic drivers

Learn More

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

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

Efficiency

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

Innovation

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

People

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

Directors’ remuneration report

Picture of Anne Minto

The Directors’ Remuneration Report has been set out to help shareholders understand our remuneration structure and how it supports Shire’s strategy and performance.

Anne Minto, OBE
Chairman of the Remuneration Committee

Our therapeutic areas

Genetic Diseases

Investing in manufacturing

We continue to invest in expanding our global biotechnology manufacturing capability. In Ireland for example, we are creating a new $400 million facility at Piercetown, County Meath. This state-of-the-art biologics manufacturing campus will play a key part in meeting the rising demand for our innovative treatments for Lysosmal Storage Diseases (“LSD”).

Our focus

on Lysosmal Storage Diseases (“LSD”)

For International Gaucher Day on October 1, 2016, we launched our “Spotlight on Gaucher” initiative on social media to raise awareness about Gaucher Disease. The initiative generated over 8,500 engagements and it was endorsed by the European Gaucher Association (“EGA”) and the National Gaucher Foundation (“NGF”) in the U.S.

As part of our ongoing Fabry Disease education for patients and their families, we launched a series of short films called “Fabry Family Tree”. The films help raise awareness of Fabry Disease as a genetic condition, its impact on other family members and the importance of early diagnosis.

on Hereditary Angioedema (“HAE”)

We have seen strong growth in our HAE products, driven by demand in the U.S., Europe and Latin America.

Key products

elaprase

REPLAGAL

VPRIV

CINRYZE

firazyr

Neuroscience

Donna
Living with ADHD

Donna is in her 40s. She was diagnosed with ADHD in 2011. She works long hours at a hospital. When not working, she loves spending time at the park with her two children — her six-year-old son and her 11-year-old daughter, who also has ADHD.

Our focus

We develop and sell leading treatments for three key areas of neuroscience: ADHD, BED and epilepsy.

Our products include VYVANSE, a treatment for ADHD and moderate to severe BED in adults. On October 17, 2016, we announced the approval of a supplemental NDA by the FDA. The VYVANSE label now includes the new longer-term maintenance of efficacy data in adults with moderate to severe BED. VYVANSE received approval from Health Canada for the treatment of BED in adults in September 2016 and was launched in Q1 2017.

Key products

Vyvanse

ONE DOSE DAILY - ADDERALL XR

intuniv

BUCCOLAM

EQUASYM - XL

Hematology

Jonus
Living with hemophilia

Jonus is now in elementary school. His mum Athena and the rest of his family are doing everything they can to make sure Jonus gets to be a kid. Whether that’s riding the blue bike he chose for his fourth birthday or learning the viola.

Our focus

We are one of the leading providers of treatments for hemophilia and von Willebrand disease (“VWD”).

ADYNOVATE was approved in Switzerland in September 2016 and launched in October.

BAXJECT III reconstitution system gained U.S. approval in July.

We launched myPKFiT the first and only registered medical device to enable personalization of ADVATE prophylaxis in France in September.

We sell RIXUBIS in 17 markets around the world and plan launches in over ten more countries over the next 18 months.

OBIZUR is approved in eight countries and we plan to launch it in an additional 11 countries in 2017.

FEIBA is the only bypass therapy with a differentiated label indicated for prophylaxis.

We launched VONVENDI in the U.S. in August. VONVENDI is the only recombinant treatment for adults living with VWD.

Key products

ADYNOVATE

FEIBA

ADVATE, my PK FiT

vonvendi

Internal Medicine

Kevin
Living with Short Bowel Syndrome

Kevin had a tough start to life because of his condition. He is now married with two daughters, including his youngest Nora. After careers in the restaurant industry and as an emergency worker, Kevin is now a dedicated caretaker for his children. He devotes his time to supporting his wife who works at the local hospital, looking after his daughters, and maintaining his health.

Our focus

GATTEX/REVESTIVE continued to perform well in 2016, with sales increasing 55 percent, primarily due to an increase in the numbers of patients on therapy. Strong uptake in the U.S. continues and the rollout across Europe and Canada has also seen strong uptake. We achieved pediatric label extension in Europe. Looking ahead, we are focusing on bringing access to more SBS patients around the world.

NATPARA also continued to perform well with sales increasing 250 percent, primarily due to an increase in the numbers of patients on therapy. We launched a new campaign in the U.S. We anticipate receiving EMA Marketing Authorization in 2017.

In September 2016, LIALDA was approved in Japan for the treatment of adults with ulcerative colitis (“UC”).

LIALDA/MEZAVANT sales rose 16 percent due to increased prescription demand.

Key products

ONCE - DAILY  Lialda, ONCE - DAILY mezavant

Gattex, Revestive

PENTASA

Natpar

Resolor

Immunology

Grace
Living with a primary immunodeficiency

Five-year old Grace loves all kinds of art, from painting to drawing. She also loves learning and when she grows up, she wants to be a veterinarian who rides a unicorn! Grace has lots of support from her three older siblings who also have a primary immunodeficiency.

Our focus

We are currently targeting four main areas of immunology: Primary Immunodeficiency (“PI”), Hypovolemia/Hypoalbuminemia, AAT Deficiency, and Severe Congenital Protein C Deficiency (“SCPCD”).

In 2016, CUVITRU was launched in the U.S. for the treatment of PI in adult and pediatric patients two years of age and older, and CUVITRU was approved in the EU.

We launched a new FDA approved self-infusion indication for AAT Deficiency — GLASSIA is the first and only AAT deficiency treatment with this indication.

Key products

HyQvia

Kiovig

Flexbumin

Glassia

Oncology

Advancing science

We are pursuing cutting-edge science to deliver innovative therapeutics to oncology patients. In 2017 we plan to reach more cancer patients than ever before, through both international and indication expansion.

Our focus

In Europe, ONCASPAR is a component of antineoplastic combination therapy in ALL in pediatric patients from birth to 18 years, and adult patients. It is the only FDA and EMA approved pegylated L-asparginase. We are continuing to increase the brand awareness and availability of ONCASPAR around the world. In 2016 for example, marketing authorizations were submitted for Brazil, Taiwan and New Zealand.

In 2016, the European Commission ("EC") granted Marketing Authorization of ONIVYDE, for the treatment of metastatic adenocarcinoma of the pancreas, in combination with 5-fluorouracil ("5-FU") and leucovorin ("LV"), in adult patients who have progressed following gemcitabine-based therapy. ONIVYDE is the first and only approved treatment option for this patient population based on pivotal Phase 3 data (NAPOLI-1) showing increased overall survival.

Key products

oncaspar

onivyde

Ophthalmology

Christine
Living with Dry Eye Disease

Christine is a registered nurse and writer. She loves going for long country walks with her family and their pet dog. She also loves a good book as well as traveling, concerts and yoga. In 2011 Christine was diagnosed with Sjogren’s syndrome, which is a risk factor for Dry Eye Disease.

Our focus

We are leading the way in an important area of ophthalmology: treating the signs and symptoms of Dry Eye Disease (“DED”).

XIIDRA, designed to treat both the signs and symptoms of DED, received FDA approval on July 11, 2016. We successfully launched the product in the U.S. on August 29, 2016, generating $54 million in product sales and 19 percent U.S. market share.

Key product

Xiidra

Download

Genetic Diseases

Neuroscience

Hematology

Internal Medicine

Immunology

Oncology

Ophthalmology

Responsibility

We are a responsible leader dedicated to delivering innovative medicines that improve the lives of patients with rare diseases.

View Our Annual Responsibility Review

Championing responsible leadership

Supporting our patients

Valuing our people and culture

Ensuring sustainable operations

Ethics and transparency

Financial highlights

Total revenue

$11.4bn

Product sales

$10.9bn

Non GAAP cash generation4

$3.5bn

Non GAAP EBITDA1, 5

$4.7bn

Non GAAP operating income3

$4.4bn

Non GAAP EBITDA margin5

39%

Non GAAP adjusted ROIC2

7%

1 This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net income (FY 2016: $327 million). 2 This is a Non GAAP financial measure. Refer to Directors’ Remuneration Report on pages 82 to 113. 3 This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Operating income from continuing operations (FY 2016: $963 million). 4 This is a Non GAAP financial measure. The most directly comparable measure under US GAAP is Net cash provided by operating activities (FY 2016: $2,659 million). 5 Non GAAP earnings before interest, tax, depreciation and amortization (“EBITDA”) as a percentage of product sales, excluding royalties and other revenues and cost of sales related to contract manufacturing revenue. The most directly comparable measure under US GAAP is Net income (FY 2016: 3 percent).

Results include legacy Baxalta since June 2016. For a reconciliation of Non GAAP financial measures to the most directly comparable measure under US GAAP, see pages 185 to 187.

Year in review

January

February

April

May

June

July

August

September

October

November

December

Global footprint

North America
employees

58%

Latin America
employees

2%

Europe
employees

35%

Asia employees

5%

U.S. Operational Headquarters
Lexington, MA

Group
Headquarters

Dublin, Ireland

International Operational Headquarters
Zug, Switzerland

Countries medicines available

100+

Employees

23,906

Where we operate

North America
Latin America
Europe
Asia

Sales by therapeutic areas

Sales by Therapeutic Areas - Genetic Diseases, Neuroscience, Hematology1, Internal Medicine, Immunology1, Oncology and Ophthalmology

Pipeline programs

View Details
Preclinical35+
Phase 16
Phase 210
Phase 317
Registration4
Preclinical 35
Phase 1 6
Phase 2 10
Phase 3 17
Registration 4
62Total

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