Shire Acquires sanaplasma AG Boosting Plasma Collection Network for Immunology Franchise

Shire Acquires sanaplasma AG Boosting Plasma Collection Network for Immunology Franchise

• The acquisition of sanaplasma AG will extend long-term plasma supply in support of Shire’s growing Immunology business
• sanaplasma AG adds 14 new centres in the Czech Republic and Hungary to Shire’s European-based plasma collection network

Dublin, Ireland – 6 September 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) announces the acquisition of sanaplasma AG, a source plasma collection company headquartered in Switzerland. The acquisition of sanaplasma AG is expected to increase Shire’s access to plasma in the longer term and add to its European plasma collection network, complementing existing core capabilities in plasma supply and manufacturing.

Plasma is essential to the manufacture of immunoglobulin therapies that help treat patients living with certain rare immunological diseases. Immunology is Shire’s largest franchise, with 18% growth on a pro-forma basis in 2017 to $4.4 billion in product sales, primarily driven by increased global demand for subcutaneous and intravenous immunoglobulin brands. This acquisition is expected to support the growth of the Immunology business and help meet the needs of patients around the world.

Sue Brown, VP Global Operations for Shire BioLife Plasma Services, said:
"The acquisition of sanaplasma AG demonstrates Shire’s commitment to its rapidly growing and leading Immunology business. The combination of sanaplasma AG’s 14 plasma centres in the Czech Republic and Hungary with our more than 100 BioLife centres in the US and Austria will help us to meet the continuously growing demand for plasma-derived medicines.”
                          
Dr. Martin Lukas, co-owner of sanaplasma AG said:
"I look forward to working with the team at Shire during the transition to help ensure continuity of supply, know-how transfer, and a smooth handover to position the business for future success as it continues to meet patient needs.”

sanaplasma AG is a privately-owned company focused on source plasma collection through its operation of 14 European plasmapheresis centres; 11 in the Czech Republic and three in Hungary.

About the Immunology Franchise

Shire’s immunology franchise has a strong legacy in developing therapies for people living with hereditary angioedema, primary and secondary immunodeficiency, and rare autoimmune and neurological conditions. We are committed to serial innovation, and our broad portfolio includes a number of therapy options that can be tailored to meet personal patient needs. Beyond our focus on developing novel treatments, we provide specialized services and support offerings that help meet the needs of our patients. Learn more at shire.com.

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NOTES TO EDITORS

About Shire

Shire is the global biotechnology leader serving patients with rare diseases and specialized conditions. We seek to push boundaries through discovering and delivering new possibilities for patient communities who often have few or no other champions. Relentlessly on the edge of what’s next, we are serial innovators with a diverse pipeline offering fresh thinking and new hope. Serving patients and partnering with healthcare communities in over 100 countries, we strive to be part of the entire patient journey to enable earlier diagnosis, raise standards of care, accelerate access to treatment, and support patients. Our diverse portfolio of therapeutic areas includes Immunology, Hematology, Genetic Diseases, Neuroscience, Internal Medicine, and Ophthalmics.
 
Championing patients is our call to action - it brings the opportunity - and responsibility - to change people’s lives.

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, projected revenues, 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 depends on third parties to supply certain inputs and services critical to its operations including certain inputs, services and ingredients critical to its manufacturing processes. 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, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
• the nature of producing plasma-based therapies 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;
• failure to comply with laws and regulations governing the sales and marketing of its products could materially impact Shire’s revenues and profitability;
• Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
• Shire’s patented products are subject to significant 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 Shire’s revenues, financial condition or results of operations;
• Shire may fail to obtain, maintain, enforce or defend the intellectual property rights required to conduct its business;
• Shire faces intense competition for highly qualified personnel from other companies and organizations;
• failure to successfully execute or attain strategic objectives from Shire’s acquisitions and growth strategy 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, could have negative consequences for Shire’s business and increase the risk of non-payment by Shire’s customers;
• changes in foreign currency exchange rates and interest rates could have a material adverse effect on Shire’s operating results and liquidity;
• Shire is subject to evolving and complex tax laws, which may result in additional liabilities that may adversely affect Shire’s financial condition or results of operations;
• if a marketed product fails to work effectively or causes adverse side effects, this could result in damage to Shire’s reputation, the withdrawal of the product and legal action against 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 faces risks relating to the expected exit of the United Kingdom from the European Union;
• Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs and may decrease its business flexibility;
• the potential uncertainty among our employees, customers, suppliers, and other business partners resulting from the announcement by Takeda Pharmaceutical Company Limited on May 8, 2018 of a recommended offer for Shire under the UK Takeover Code; and

a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in "ITEM1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.

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.