Released : Sep 05, 2016 07:00



U.S. Securities and Exchange Commission filings

Dublin, Ireland -  September 2, 2016 - Shire plc (LSE: SHP, NASDAQ: SHPG)
informs its shareholders that on September 2, 2016 it filed with the U.S.
Securities and Exchange Commission ('SEC'):

  * a Current Report on Form 8-K reporting updated annual and interim financial
    statements for Shire plc for the year ended December 31, 2015 and the three
    months ended March 31, 2016 and June 30, 2016, including additional
    information pursuant to financial reporting requirements for Baxalta
    Incorporated and Shire Acquisitions Investments Ireland DAC, each
    subsidiaries of Shire plc;

  * a Current Report on Form 8-K reporting certain historical disclosure from
    previous public filings of Baxalta Incorporated and updated unaudited pro
    forma condensed combined statements of income for the year ended December
    31, 2015 and the six months ended June 30, 2016; and

  * a Registration Statement on Form S-3 in respect of debt securities that may
    be offered from time to time by Shire Acquisitions Investments Ireland DAC,
    and guaranteed by Shire plc,

(together, the 'Documents').

The Documents can be found on the SEC website at http://www.sec.gov.

A copy of the Documents will be submitted to the National Storage Mechanism on
September 5, 2016 and will shortly thereafter be available for inspection at
http://www.morningstar.co.uk/uk/NSM.

For further information please contact:

Investor Relations

Sarah Elton-Farr                seltonfarr@shire.com       +44 1256 894157

Ian Karp                        ikarp@shire.com            +1 781 482 9018

Robert Coates                   rcoates@shire.com          +44 1256 894874

Media

Gwen Fisher                     gfisher@shire.com          +1 484 595 9836

Debbi Ford                      debbi.ford@shire.com       +1 617 949 9083

NOTES TO EDITORS

About Shire

Shire is the leading global biotechnology company focused on serving people
with rare diseases and other highly specialized conditions. We have
best-in-class products available in more than 100 countries across core
therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal
Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and
Hereditary Angioedema; a growing franchise in Oncology; and an emerging,
innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and
deliver breakthrough therapies for the hundreds of millions of people in the
world affected by rare diseases and other high-need conditions, and who lack
effective therapies to live their lives to the fullest.

www.shire.com

Forward-Looking Statements

Statements included herein that are not historical facts, including without
limitation statements concerning future strategy, plans, objectives,
expectations and intentions, the anticipated timing of clinical trials and
approvals for, and the commercial potential of, inline or pipeline products are
forward-looking statements. Such 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, the following:

  * Shire's products may not be a commercial success;
  * increased pricing pressures and limits on patient access as a result of
    governmental regulations and market developments may affect Shire's future
    revenues, financial condition and results of operations;
  * Shire conducts its own manufacturing operations for certain of its products
    and is reliant on third party contract manufacturers 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 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 manufacture of Shire's products is subject to extensive oversight by
    various regulatory agencies.  Regulatory approvals or interventions
    associated with changes to manufacturing sites, ingredients or
    manufacturing processes could lead to significant delays, an increase in
    operating costs, lost product sales, an interruption of research activities
    or the delay of new product launches;
  * certain of Shire's therapies involve lengthy and complex processes, which
    may prevent Shire from timely responding to market forces and effectively
    managing its production capacity;
  * Shire has a portfolio of products in various stages of research and
    development. The successful development of these products is highly
    uncertain and requires significant expenditures and time, and there is no
    guarantee that these products will receive regulatory approval;
  * 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 affect Shire's revenues, financial
    conditions or results of operations;
  * Shire's products and product candidates face substantial competition in the
    product markets in which it operates, including competition from generics;
  * adverse outcomes in legal matters, tax audits 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 the combined company's revenues, financial condition or results
    of operations;
  * inability to successfully compete for highly qualified personnel from other
    companies and organizations;
  * failure to achieve the strategic objectives with respect to Shire's
    acquisition of NPS Pharmaceuticals, Inc., Dyax Corp. ('Dyax') or Baxalta
    Inc. ('Baxalta')may adversely affect Shire's financial condition and
    results of operations;
  * Shire's growth strategy depends in part upon its ability to expand its
    product portfolio through external collaborations, which, if unsuccessful,
    may adversely affect the development and sale of its products;
  * a slowdown of global economic growth, or economic instability of countries
    in which Shire does business, as well as changes in foreign currency
    exchange rates and interest rates, that adversely impact the availability
    and cost of credit and customer purchasing and payment patterns, including
    the collectability of customer accounts receivable;
  * failure of a marketed product to work effectively or if such a product is
    the cause of adverse side effects could result in damage to the Shire's
    reputation, the withdrawal of the product and legal action against Shire;
  * 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 significant legal costs and the
    payment of substantial compensation or fines;
  * Shire is dependent on information technology and its systems and
    infrastructure face certain risks, including from service disruptions, the
    loss of sensitive or confidential information, cyber-attacks and other
    security breaches or data leakages that could have a material adverse
    effect on Shire's revenues, financial condition or results of operations;
  * Shire incurred substantial additional indebtedness to finance the Baxalta
    acquisition, which may decrease its business flexibility and increase
    borrowing costs;
  * difficulties in integrating Dyax or Baxalta into Shire may lead to the
    combined company not being able to realize the expected operating
    efficiencies, cost savings, revenue enhancements, synergies or other
    benefits at the time anticipated or at all; and

other risks and uncertainties detailed from time to time in Shire's filings
with the Securities and Exchange Commission, including those risks outlined in
'ITEM 1A: Risk Factors' in Shire's Quarterly Report on Form 10-Q for the
quarter ended June 30, 2016.

All forward-looking statements attributable to us or any person acting on our
behalf are expressly qualified in their entirety by this cautionary statement.
Readers are cautioned not to place undue reliance on these forward-looking
statements that speak only as of the date hereof. Except to the extent
otherwise required by applicable law, we do not undertake any obligation to
update or revise forward-looking statements, whether as a result of new
information, future events or otherwise.

Shire plc published this content on 05 September 2016 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 05 September 2016 06:05:10 UTC.

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