- 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 and 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 U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.
CONTACT: For further information please contact: Investor Relations: EricRojas, erojas@shire.com, +1-781-482-0999; Sarah Elton-Farr,seltonfarr@shire.com, +44-1256-894157; Media: Jessica Mann,jmann@shire.com, +44-1256-894-280; Gwen Fisher, gfisher@shire.com,+1-484-595-9836; Jessica Cotrone, jcotrone@shire.com, +1-781-482-9538
