Financial Express (Holdings) Limited (“we”, “our”, “us” and derivatives) are committed to protecting and respecting your privacy. This Privacy Policy, together with our Terms of Use, sets out the basis on which any personal data that we collect from you, or that you provide to us, will be processed by us relating to your use of any of the below websites (“sites”).

  • FEAnalytics.com
  • FEInvest.net
  • FETransmission.com
  • Investegate.co.uk
  • Trustnet.hk
  • Trustnetoffshore.com
  • Trustnetmiddleeast.com

For the purposes of the Data Protection Act 1998, the data controller is Trustnet Limited of 2nd Floor, Golden House, 30 Great Pulteney Street, London, W1F 9NN. Our nominated representative for the purpose of this Act is Kirsty Witter.

WHAT INFORMATION DO WE COLLECT ABOUT YOU?

We collect information about you when you register with us or use any of our websites / services. Part of the registration process may include entering personal details & details of your investments.

We may collect information about your computer, including where available your operating system, browser version, domain name and IP address and details of the website that you came from, in order to improve this site.

You confirm that all information you supply is accurate.

COOKIES

In order to provide personalised services to and analyse site traffic, we may use a cookie file which is stored on your browser or the hard drive of your computer. Some of the cookies we use are essential for the sites to operate and may be used to deliver you different content, depending on the type of investor you are.

You can block cookies by activating the setting on your browser which allows you to refuse the setting of all or some cookies. However, if you use your browser settings to block all cookies (including essential cookies) you may not be able to access all or part of our sites. Unless you have adjusted your browser setting so that it will refuse cookies, our system will issue cookies as soon as you visit our sites.

HOW WE USE INFORMATION

We store and use information you provide as follows:

  • to present content effectively;
  • to provide you with information, products or services that you request from us or which may interest you, tailored to your specific interests, where you have consented to be contacted for such purposes;
  • to carry out our obligations arising from any contracts between you and us;
  • to enable you to participate in interactive features of our service, when you choose to do so;
  • to notify you about changes to our service;
  • to improve our content by tracking group information that describes the habits, usage, patterns and demographics of our customers.

We may also send you emails to provide information and keep you up to date with developments on our sites. It is our policy to have instructions on how to unsubscribe so that you will not receive any future e-mails. You can change your e-mail address at any time.

In order to provide support on the usage of our tools, our support team need access to all information provided in relation to the tool.

We will not disclose your name, email address or postal address or any data that could identify you to any third party without first receiving your permission.

However, you agree that we may disclose to any regulatory authority to which we are subject and to any investment exchange on which we may deal or to its related clearing house (or to investigators, inspectors or agents appointed by them), or to any person empowered to require such information by or under any legal enactment, any information they may request or require relating to you, or if relevant, any of your clients.

You agree that we may pass on information obtained under Money Laundering legislation as we consider necessary to comply with reporting requirements under such legislation.

ACCESS TO YOUR INFORMATION AND CORRECTION

We want to ensure that the personal information we hold about you is accurate and up to date. You may ask us to correct or remove information that is inaccurate.

You have the right under data protection legislation to access information held about you. If you wish to receive a copy of any personal information we hold, please write to us at 3rd Floor, Hollywood House, Church Street East, Woking, GU21 6HJ. Any access request may be subject to a fee of £10 to meet our costs in providing you with details of the information we hold about you.

WHERE WE STORE YOUR PERSONAL DATA

The data that we collect from you may be transferred to, and stored at, a destination outside the European Economic Area (“EEA”). It may be processed by staff operating outside the EEA who work for us or for one of our suppliers. Such staff may be engaged in, amongst other things, the provision of support services. By submitting your personal data, you agree to this transfer, storing and processing. We will take all steps reasonably necessary, including the use of encryption, to ensure that your data is treated securely and in accordance with this privacy policy.

Unfortunately, the transmission of information via the internet is not completely secure. Although we will do our best to protect your personal data, we cannot guarantee the security of your data transmitted to our sites; any transmission is at your own risk. You will not hold us responsible for any breach of security unless we have been negligent or in wilful default.

CHANGES TO OUR PRIVACY POLICY

Any changes we make to our privacy policy in the future will be posted on this page and, where appropriate, notified to you by e-mail.

OTHER WEBSITES

Our sites contain links to other websites. If you follow a link to any of these websites, please note that these websites have their own privacy policies and that we do not accept any responsibility or liability for these policies. Please check these policies before you submit any personal data to these websites.

CONTACT

If you want more information or have any questions or comments relating to our privacy policy please email publishing@financialexpress.net in the first instance.

 Information  X 
Enter a valid email address

Shire plc (SHP)

  Print      Mail a friend       Annual reports

Monday 23 June, 2014

Shire plc

The Path to US$10 Billion in Product Sales by 2020


NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION (IN WHOLE OR IN PART) IN, INTO OR 
   FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE    
                      RELEVANT LAWS OF SUCH JURISDICTION.                      

For immediate release 23 June 2014

                                   Shire plc                                   

              The Path to US$10 Billion in Product Sales by 2020               

Presentation for analysts and investors to be held at 13:00 British Summer Time
                                     today                                     

The management of Shire plc ("Shire" or the "Company") (LSE: SHP, NASDAQ: SHPG)
has transformed the Company over the last year, creating the platform to
deliver substantially more value to shareholders and benefits for patients, and
to enhance its leadership position in Rare Diseases.

The `One Shire' efforts have led to:

  * Accelerated top-line growth with product sales increasing 19% in Q12014
    (from Q12013);
   
  * Enhanced profitability reflected in 45% Non GAAP EBITDA margins achieved in
    Q12014(1);
   
  * Material improvements in the pipeline via organic progression and focused M
    &A; and
   
  * Total shareholder return, including reinvestment of dividends, of 99% from
    2 May 2013 to 19 June 2014 (the day before the announcement by AbbVie Inc.
    regarding its possible cash and share offer for the Company).
   
With the benefit of a focused strategy, a high-performing management team, and
a lean operating model, Shire expects to deliver double-digit compound annual
product sales growth from its current portfolio and to more than double its
2013 annual product sales to US$10 billion by 2020.

Shire is delivering a presentation today setting out the continued progress in
executing its strategy, which centers on delivering innovative therapies for
significant unmet need in Rare Diseases and other high-value specialty
indications.

The Board believes that Shire's focused growth strategy and efficient cost base
will continue to deliver significant shareholder value and patient benefits.

Flemming Ornskov, Chief Executive Officer of Shire, said: "We have a long range
plan that envisages more than doubling product sales from just under US$5
billion in 2013 to US$10 billion by 2020 from the current portfolio, even
without the impact of any additional M&A, licensing and the pipeline
development from certain recent transactions.

We have put in place the team and the strategy which have already led to a
marked acceleration in product sales over the last 12 months. Furthermore, we
have stepped up the efficiency of the business, increasing Non GAAP EBITDA
margins by eight percentage points year on year from Q12013 to Q12014(1).

As a consequence, our record of creating total shareholder returns for Shire
shareholders has substantially outperformed that of our peer group and relevant
market indices in both the UK and US from 1 January 2009 until 19 June 2014.

We have created leading franchises in Rare Diseases, Neuroscience and
Gastrointestinal (GI) and are moving into promising new therapeutic areas such
as ophthalmology, as well as boosting our innovative pipeline. We are confident
that our ambitious team has the capabilities and the platform to drive strong
future sales growth and to enhance Shire's leadership position in Rare
Diseases."

The Company is providing new, long-term, financial targets which highlight the
significant potential for shareholder value creation. From 2013 to 2020 Shire
is targeting sustainable product sales growth leading to annual product sales
(excluding the impact of any additional M&A, licensing and certain recent
acquisitions) of US$10 billion by 2020, comprising US$7 billion from in-line
product sales and US$3 billion in sales from existing pipeline products. In the
medium term Shire is also targeting annual product sales of US$6.5 billion by
2016.

Today's presentation also includes the following additional information:

  * From 2 May 2013 to 19 June 2014, Shire's total shareholder return,
    including reinvestments of dividends, has been 99%, which compares to a
    median of 44% for biotechnology peers(3), 10% for the FTSE 100 and 26% for
    the S&P 500;
   
  * From 1 January 2009 to 19 June 2014, Shire's total shareholder return,
    including reinvestments of dividends, has been 281%, which compares to a
    median of 212% for biotechnology peers(3), 88% for the FTSE 100 and 144%
    for the S&P 500; and
   
  * The Company has made significant progress subsequent to and including the
    strong Q1 2014 results. Examples include:
   
  * 
      + The announcement of the planned resubmission of SHP465 on 1 May 2014;
       
      + The acquisition of Lumena Pharmaceuticals announced on 12 May 2014;
       
      + In early June, Shire agreed with the FDA that it will conduct pediatric
        clinical studies to investigate the potential use of VYVANSE® for the
        treatment of ADHD in children aged 4 to 5; based on the results of
        these pediatric studies and the FDA's review of the data, Shire could
        receive a six-month extension of the exclusivity period for VYVANSE®
        patents which expire in 2023; and
       
      + The announcement of the 2015 planned filing of Lifitegrast for the
        treatment of Dry Eye Disease on 16 May 2014.
       
The presentation and the contents of this announcement are based on the key
sources, bases and assumptions set out at the end of this announcement.

New management has created a platform to deliver sustainable sales growth and
superior patient outcomes

Shire has generated strong momentum and has created a platform to deliver
double-digit compound annual product sales growth from its existing product
portfolio and pipeline through 2020 with the following components:

  * Continued operational efficiency, commercial excellence, and a scalable
    operating model;
   
  * Growing its leading franchises in Rare Diseases, Neuroscience, GI, and
    building into other emerging areas through an innovative pipeline; and
   
  * A simple organisational structure and a high-performing management team.
   
In addition the management intends to pursue business development to reinforce
its core and expand and grow its adjacent therapeutic areas, which could
further enhance Shire's double-digit compound annual product sales growth.

Marked acceleration in sales growth since arrival of new management

  * Increase in Q12014 product sales of 19% compared to Q12013;
   
  * Focus on improving Rare Diseases competitive performance;
   
  * Sharpened Neuroscience customer focus;
   
  * Improved market position in 5-ASA GI market;
   
  * Addition of ViroPharma to Rare Diseases business unit; and
   
  * Divestment of DERMAGRAFT®.
   
New management has improved the efficiency of the business, increasing group
Non GAAP EBITDA margins from 37% in Q12013 to 45% in Q12014(1)

  * Transition to `One Shire' organisation structure;
   
  * Integrated R&D under a single leadership team;
   
  * Creation of a single, consolidated international structure;
   
  * Streamlined other corporate functions; and
   
  * Termination of programs that did not fit strategy or commercial criteria.
   
Shire is growing its leading franchises in Rare Diseases, Neuroscience, GI, and
is building into other emerging areas through an innovative pipeline

  * Leading positions in commercially attractive therapeutic areas - Rare
    Diseases (2013 product sales US$2.0 billion(4)); Neuroscience (2013 product
    sales US$1.6 billion) and GI (2013 product sales $0.8 billion);
   
  * 
      + By 2020, Shire expects to achieve product sales of over US$3 billion in
        Rare Diseases, over US$3 billion in Neuroscience and over US$1.3
        billion in GI;
       
  * Adding to existing platforms in enzyme / protein replacement via internal
    research and collaborations (including Renal, Fibrosis, Intrathecal and
    mRNA assets);
   
  * Ongoing assessment of additional acquisition targets where Shire has
    expertise and can increase value;
   
  * Extending its Rare Diseases model to new indications, for example, Lumena
    for rare GI disorders and Fibrotech(5) for rare Renal disorders;
   
  * Organic progress with pipeline
   
  * 
      + Resubmission of SHP465 for high-growth ADHD adult segment with expected
        launch in H1 2015
       
      + Positive Phase III results for LDX in Binge Eating Disorder, with a
        plan to file an NDA in Q3 2014 and expected launch in Q1 2015; and
       
      + Ongoing progression of SHP609 and SHP610 to treat the CNS
        manifestations of Hunter and Sanfilippo A syndromes
       
  * Focused on expanding scale in commercially attractive adjacent therapeutic
    areas, for example Ophthalmology and Hematology / Oncology.
   
New management's focused business development strategy has added products with
significant sales potential

  * Acquisitions position Shire in new therapeutic areas (e.g. Lifitegrast is a
    potential blockbuster in ophthalmology with expected NDA filing in Q12015);
    and
   
  * Acquisitions strengthen Rare Diseases pipeline e.g. CINRYZE® new potential
    uses (from ViroPharma), acquisitions of Lumena (in GI), Premacure (in
    ophthalmology) and Fibrotech(5) (in diabetic nephropathy).
   
New financial targets and additional information

Shire is aiming to become a leading high-growth global biotechnology group and
to build upon its leadership position in Rare Diseases by executing additional
phases of its efficiency program, commercialising and progressing its existing
pipeline and adding new growth through business development and internal
research.

Today's presentation includes the following additional information in relation
to Shire's risk adjusted financial targets and non-risk adjusted sales
forecasts for selected key pipeline products:

  * Product sales targets of US$6.5 billion by 2016 and US$10 billion by 2020;
   
  * Double-digit compound annual product sales growth from the current
    portfolio through 2020 (excluding the impact of M&A, in-licensing and
    pipeline development from certain recent transactions);
   
  * Rare Diseases business unit sales of over US$3 billion by 2020;
   
  * Neuroscience business unit sales of over US$3 billion by 2020;
   
  * GI business unit sales of over US$1.3 billion by 2020;
   
  * Lifitegrast product sales in 2020 of in excess of US$1 billion (unrisked
    (6));
   
  * SHP465 product sales in 2020 of approximately US$500 million (unrisked(6));
   
  * SHP607 (PREMIPLEX®) product sales in 2020 of in excess of US$500 million
    (unrisked(6));
   
  * LDX product sales (as a treatment of Binge Eating Disorder) in 2020 of
    approximately US$300 million (unrisked(6));
   
  * Pipeline intrathecal programs product sales in 2020 of approximately US$400
    million (unrisked(6));
   
  * Peak sales potential (unrisked) for LUM001 and LUM002 of in excess of US$3
    billion in total; and
   
  * Peak sales potential (unrisked) for the innovative pipeline of over US$7
    billion(7).
   
Shire's existing product portfolio and pipeline is expected to achieve US$6.5
billion product sales by 2016 and US$10 billion product sales by 2020. The
impact of future M&A, in-licensing opportunities and pipeline development from
recent transactions (Fibrotech and Lumena) represent further potential upside
to these product sales targets.

Presentation for analysts and investors

A presentation for analysts and investors will be held at 13:00 BST and can be
joined live, via teleconference and webcast. Details can be found on the Shire
Investor Relations website http://www.shire.com/shireplc/en/investors

Notes

 1. This is a Non GAAP financial measure. The most directly comparable measure
    under US GAAP is net income (Q12014: US$230 million, or 18% of product
    sales; Q12013: US$65 million, or 6% of product sales).
   
 2. This is a Non GAAP financial measure. Non GAAP EBITDA CAGR for the period
    2008-2013 was 14%. The most directly comparable measure under U.S. GAAP is
    net income (2013: US$665 million, or 14% of product sales; 2008: US$156
    million, or 6% of product sales), with a CAGR for the 2008-2013 period of
    34%.
   
 3. Selected biotechnology peers include Alexion, Amgen, Biogen Idec, Celgene
    and Gilead.
   
 4. Product sales of US$2 billion for the 2013 financial year on a pro forma
    basis including CINRYZE® product sales (which was acquired in January
    2014).
   
 5. The acquisition of Fibrotech has yet to close.
   
 6. This represents Shire management's estimate of the potential annual net
    sales for the product in 2020. This estimate is not risk-adjusted and is
    made using customary pharmaceutical industry forecasting methods.
   
 7. Over US$7 billion peak sales potential includes products that have
    completed Phase 1, but excludes lifecycle management programs.
   
Key Sources, Bases and Assumptions

The Shire forecasts and targets included in this announcement and the
presentation are derived from Shire's Long Range Plan for 2014 to 2020 (the
"LRP"), business papers produced to support the LRP and Shire papers
subsequently produced as part of the business planning process.  Shire produces
a long range plan annually.  The LRP was updated in September 2013 and was
reviewed by the Board of Shire in October 2013. A revised LRP was developed to
reflect the acquisition of ViroPharma, the disposal of DERMAGRAFT®, the
termination of the VYVANSE® Major Depressive Disorder program, 2013 full year
reported financial results and other events in 2014. This revised LRP was
reviewed by the Board of Shire most recently in June 2014.

The forecast product sales targets for 2016 and 2020 in this announcement and
the presentation are consistent with the LRP for the period from 2014 to 2020,
which is at constant exchange rates, and reflects net sales for each product
and key line extensions currently identified as in Phase III, Phase II and
those in (or soon to enter) Phase I included in the LRP as launching before the
end of 2020.

The forecast product sales included in the LRP are risk-adjusted to reflect
Shire's assessment of the individual probability of launch of products in
development, and the probability of success in further life cycle management
trials.  Estimates for these probabilities are based on industry wide data for
relevant clinical trials in the pharmaceutical industry at a similar stage of
development. 

For each pharmaceutical product, there is a range of possible outcomes from
clinical development, driven by a number of variables - including safety,
efficacy and product labelling. In addition, if a product is approved, the
effect of commercial factors including the patient population, the competitive
environment, pricing and reimbursement is also uncertain.  As a result, the
actual net sales achieved by a product over its commercial life will be
different, perhaps materially so, from the risk adjusted net sales figures in
this announcement and the presentation and should be considered in this light.

Peak year sales referred to in this announcement and the presentation are Shire
management's estimates of the highest annual net sales for the relevant
product. These peak year sales estimates are not risk-adjusted, and are made
using customary pharmaceutical industry forecasting methods.  Some of these
peak year sales occur in years later than 2020, but these estimates are
consistent with the plans and projections of the LRP period. 

Peak year sales may occur in different years for each product, depending on
trial outcomes, launch dates, pricing assumptions and exclusivity periods,
amongst other things.  The aggregation of peak sales is the sum of peak year
sales for each asset and not for one particular year.  Peak year sales are net
product sales at nominal values and are undiscounted.

2020 sales for individual products referred to in this announcement and the
presentation are Shire management's estimates of the potential annual net sales
for the relevant product. These estimates are not risk-adjusted, and are made
using customary pharmaceutical industry forecasting methods.

Attention is drawn to the notice set out under the heading Forward-Looking
Statements below.

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better lives.

We provide treatments in Rare Diseases, Neuroscience, Gastrointestinal and
Internal Medicine and we are developing treatments for symptomatic conditions
treated by specialist physicians in other targeted therapeutic areas such as
Ophthalmology..

Shire's product sales from continuing operations have increased from US$2,754
million in the financial year to 31 December 2008 to US$4,757 million in the
financial year to 31 December 2013, representing a five-year compound annual
growth rate of 11.6%. Shire's Non GAAP diluted earnings per ADS have increased
from US$3.86 in the financial year to 31 December 2008 to US$7.66 in the
financial year to 31 December 2013, representing a five-year compound annual
growth rate of 14.7%. Shire's US GAAP diluted earnings per ADS have increased
from US$0.86 in the financial year to 31 December 2008 to US$3.53 in the
financial year to 31 December 2013, representing a five-year compound annual
growth rate of 32.7%.

www.shire.com

CONTACTS

Shire                                                                          
                                                                               
Jessica Mann                                                 +44 1256 894 280  
                                                                               
Stephanie Fagan                                              +1 201 572 9581   
                                                                               
FTI Consulting (Media Adviser to the                                           
Company)                                                                       
                                                                               
Andrew Lorenz (London)                                       +44 77 7564 1807  
                                                                               
Ben Atwell (London)                                          +44 20 3727 1000  
                                                                               
David B. Roady (New York)                                    +1 212 850 5600   
                                                                               
Robert Stanislaro (New York)                                 +1 212 850 5600   
                                                                               
Citi (Financial Adviser to the Company)                                        
                                                                               
Christopher Hite                                             +1 212 816 1818   
                                                                               
Jan Skarbek                                                  +44 20 7986 4000  
                                                                               
Deutsche Bank (Financial Adviser to the                                        
Company)                                                                       
                                                                               
Nick Bowers                                                  +44 20 7545 8000  
                                                                               
Ben Lawrence                                                                   
                                                                               
Evercore (Financial Adviser to the Company)                                    
                                                                               
Francois Maisonrouge                                         +44 20 7653 6000  
                                                                               
Edward Banks                                                                   
                                                                               
Goldman Sachs (Financial Adviser to the                                        
Company)                                                                       
                                                                               
Anthony Gutman                                               +44 20 7774 1000  
                                                                               
Raj Shah                                                                       
                                                                               
Morgan Stanley (Financial Adviser to the                                       
Company)                                                                       
                                                                               
Michele Colocci                                              +44 20 7425 8000  
                                                                               
Colm Donlon                                                                    
                                                                               
Peter Moorhouse (Corporate Broking)                                            

A copy of this announcement will be available at www.shire.com. The content of
the website referred to in this announcement is not incorporated into and does
not form part of this announcement.

FURTHER INFORMATION

Evercore Partners International LLP ("Evercore"), which is authorised and
regulated in the United Kingdom by the Financial Conduct Authority, is acting
as financial adviser exclusively for Shire and no one else in connection with
the matters referred to in this announcement and will not regard any other
person as its client in relation to the matters referred to in this
announcement and will not be responsible to anyone other than Shire for
providing the protections afforded to clients of Evercore, nor for providing
advice in relation to the matters referred to in this announcement.

Morgan Stanley & Co. International plc, which is authorised by the Prudential
Regulation Authority and regulated by the Financial Conduct Authority and the
Prudential Regulation Authority in the United Kingdom, is acting as financial
adviser to Shire and no one else in connection with the matters referred to in
this announcement. In connection with such matters, Morgan Stanley & Co.
International plc, its affiliates and its and their respective directors,
officers, employees and agents will not regard any other person as their
client, nor will they be responsible to any other person other than Shire for
providing the protections afforded to their clients or for providing advice in
connection with the contents of this announcement or any other matter referred
to herein.

Citigroup Global Markets Limited, which is authorised by the Prudential
Regulation Authority and regulated by the Financial Conduct Authority and the
Prudential Regulation Authority, each in the United Kingdom, is acting as
financial adviser to Shire and for no one else in connection with the matters
set out in this announcement. In connection with such matters, Citigroup Global
Markets Limited, its affiliates and its and their respective directors,
officers, employees and agents will not regard any other person as their
client, nor will they be responsible to anyone other than Shire for providing
the protections afforded to its clients or for providing advice in connection
with the contents of this announcement or any matter referred to herein.

Goldman Sachs International, which is authorised by the Prudential Regulation
Authority and regulated by the Financial Conduct Authority and the Prudential
Regulation Authority in the United Kingdom, is acting as financial adviser to
Shire and no one else in connection with the matters referred to in this
announcement. In connection with such matters Goldman Sachs International, its
affiliates and its and their respective directors, officers, employees and
agents will not regard any other person as their client, nor will they be
responsible to anyone other than Shire for providing the protections afforded
to clients of Goldman Sachs International, or for giving advice in connection
with the contents of this announcement or any other matter referred to herein.

Deutsche Bank AG is authorised under German Banking Law (competent authority:
BaFIN - Federal Financial Supervisory Authority). Deutsche Bank AG, London
Branch is further authorised by the Prudential Regulation Authority and is
subject to limited regulation by the Financial Conduct Authority and Prudential
Regulation Authority. Deutsche Bank is acting as financial adviser to Shire and
no one else in connection with the contents of this Announcement and will not
be responsible to anyone other than Shire for providing the protections
afforded to its clients or for providing advice in connection with the contents
of this Announcement or any matter referred to herein.

FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATE
SECURITIES LITIGATION REFORM ACT OF 1995

Statements included in this announcement that are not historical facts are
forward-looking statements. Forward-looking statements involve a number of
risks and uncertainties and are subject to change at any time. In the event
such risks or uncertainties materialize, Shire's results could be materially
adversely affected. The risks and uncertainties include, but are not limited
to, that:

  * Shire's products may not be a commercial success;
   
  * revenues from ADDERALL XR® are subject to generic erosion and revenues from
    INTUNIV® will become subject to generic competition starting in December
    2014;
   
  * the failure to obtain and maintain reimbursement, or an adequate level of
    reimbursement, by third-party payors in a timely manner for Shire's
    products may impact future revenues, financial condition and results of
    operations;
   
  * Shire conducts its own manufacturing operations for certain of its Rare
    Diseases products and is reliant on third party contractors to manufacture
    other products and to provide goods and services. Some of Shire's products
    or ingredients are only available from a single approved source for
    manufacture. Any disruption to the supply chain for any of Shire's products
    may result in the Shire being unable to continue marketing or developing a
    product or may result in Shire being unable to do so on a commercially
    viable basis for some period of time;
   
  * the development, approval and manufacturing of Shire's products is subject
    to extensive oversight by various regulatory agencies. Submission of an
    application for regulatory approval of any of Shire's product candidates,
    such as Shire's planned submission of a New Drug Application to the FDA for
    lifitegrast as a treatment for the signs and symptoms of dry eye disease in
    adults, may be delayed for any number of reasons and, once submitted, may
    be subjected to lengthy review and ultimately rejected. Moreover,
    regulatory approvals or interventions associated with changes to
    manufacturing sites, ingredients or manufacturing processes could lead to
    significant delays, increase in operating costs, lost product sales, an
    interruption of research activities or the delay of new product launches;
   
  * the actions of certain customers could affect Shire's ability to sell or
    market products profitably. Fluctuations in buying or distribution patterns
    by such customers can adversely impact Shire's revenues, financial
    conditions or results of operations;
   
  * investigations or enforcement action by regulatory authorities or law
    enforcement agencies relating to Shire's activities in the highly regulated
    markets in which it operates may result in the distraction of senior
    management, significant legal costs and the payment of substantial
    compensation or fines;
   
  * adverse outcomes in legal matters and other disputes, including Shire's
    ability to enforce and defend patents and other intellectual property
    rights required for its business, could have a material adverse effect on
    Shire's revenues, financial condition or results of operations;
   
  * Shire faces intense competition for highly qualified personnel from other
    companies, academic institutions, government entities and other
    organizations. Shire is undergoing a corporate reorganization and the
    consequent uncertainty could adversely impact Shire's ability to attract
    and/or retain the highly skilled personnel needed for Shire to meet its
    strategic objectives;
   
  * failure to achieve Shire's strategic objectives with respect to the
    acquisition of ViroPharma Incorporated may adversely affect Shire's
    financial condition and results of operations;
   
and other risks and uncertainties detailed from time to time in Shire's filings
with the US Securities and Exchange Commission, including its most recent
Annual Report on Form 10-K.

NON GAAP MEASURES

  * The announcement contains financial measures not prepared in accordance
    with US GAAP.
   
  * These Non GAAP financial measures are used by Shire's management to make
    operating decisions because they facilitate internal comparisons of the
    Company's performance to historical results and to competitors' results.
    They should not be considered in isolation from, as substitutes for, or
    superior to financial measures prepared in accordance with US GAAP.
   
  * The following items are excluded from these Non GAAP financial measures:
   
  * 
      + Amortization and asset impairments:
       
      + 
          o Intangible asset amortization and impairment charges; and
           
          o Other than temporary impairment of investments.
           
      + Acquisitions and integration activities:
       
      + 
          o Upfront payments and milestones in respect of in-licensed and
            acquired products;
           
          o Costs associated with acquisitions, including transaction costs,
            and fair value adjustments on contingent consideration and acquired
            inventory;
           
          o Costs associated with the integration of companies; and
           
          o Non-controlling interest in consolidated variable interest
            entities.
           
      + Divestments, re-organizations and discontinued operations:
       
      + 
          o Gains and losses on the sale of non-core assets;
           
          o Costs associated with restructuring and re-organization activities;
           
          o Termination costs; and
           
          o Income / (losses) from discontinued operations.
           
      + Legal and litigation costs:
       
      + 
          o Net legal costs related to the settlement of litigation, government
            investigations and other disputes (excluding internal legal team
            costs).
           
  * A reconciliation of these Non GAAP financial measures to the most directly
    comparable measure under US GAAP can be found within the Investor's section
    on Shire's website at www.shire.com.
   
                                                                            
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX

Press Release                                     
                                                  
www.shire.com