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Jan 22, 2016 - Shire Completes Acquisition of Dyax
Nov 2, 2015 - Shire to Acquire Dyax Corp, expanding and extending industry-leading Hereditary Angioedema (HAE) portfolio
The passage of time and/or the occurrence of subsequent events can render the materials on this website inaccurate or incomplete. Viewers of this website should consider the dates of issuance of all materials on this website and understand that Shire assumes no obligation to update or correct the materials on this website, whether as a result of new information, future events or otherwise.
FORWARD LOOKING STATEMENTS
Statements included herein that are not historical facts, including without limitation statements concerning our proposed acquisition of Dyax and the timing and financial and strategic benefits thereof, the anticipated timing of clinical trials and approval, as well as the commercial potential, for DX-2930 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, that:
- Shire’s and Dyax products may not be a commercial success;
- product sales from ADDERALL XR and INTUNIV are subject to generic competition;
- the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for Shire's products may affect 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;
- Shire and Dyax have portfolios of products in various stages of research and development. The successful development of these products, including DX-2930, 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 condition 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 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 and organizations. Shire is undergoing a corporate reorganization and was the subject of an unsuccessful acquisition proposal and the consequent uncertainty could adversely affect 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 NPS Pharmaceuticals Inc. and Dyax may adversely affect Shire’s financial condition and results of operations;
- Shire's strategy to acquire Baxalta may not be successful: Baxalta may refuse to cooperate with Shire; if the proposed combination is consummated, the businesses may not be integrated successfully, including that expected synergies and other benefits of the combination may not be realized and unforeseen costs may arise; and disruption caused by the proposed transaction may adversely affect Shire;
- 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’s proposed acquisition of Dyax may not be consummated due to the occurrence of an event, change or other circumstances that gives rise to the termination of the merger agreement;
- A governmental or regulatory approval required for the proposed acquisition of Dyax may not be obtained, or may be obtained subject to conditions that are not anticipated, or another condition to the closing of the proposed acquisition may not be satisfied;
- Dyax may be unable to retain and hire key personnel and/or maintain its relationships with customers, suppliers and other business partners pending the consummation of the proposed acquisition by Shire, or Dyax business may be disrupted by the proposed acquisition, including increased costs and diversion of management time and resources;
difficulties in integrating Dyax 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 and Dyax’s filings with the Securities and Exchange Commission (the “SEC”), including those risks outlined in “Item 1A: Risk Factors” in Shire’s Annual Report on Form 10-K for the year ended December 31, 2014.
No statement in this announcement is intended as a profit forecast or a profit estimate and no statement in this announcement should be interpreted to mean that earnings per Shire security for the current or future financial years would necessarily match or exceed the historical published earnings per Shire security.
In assessing the proposed transaction, Shire used projections regarding its accretive impact and growth profile, which were based on internal forecasts of its Non GAAP diluted earnings per share. These forecasts are Non GAAP financial measures derived by excluding certain amounts that would be included in financial measures as determined under US GAAP. Amounts which have been excluded are consistent with Shire's established Non GAAP policy, as included on pages 30 to 31 of Shire's Q3 earnings release. Shire is unable to present quantitative reconciliations because management cannot currently reasonably predict with sufficient reliability all of the necessary components of the comparable US GAAP financial measure.