Horizon Therapeutics plc Announces Purchase of Manufacturing Facility to Support Growth of On-Market Rare Disease and Pipeline Biologics

- 44,000 square foot facility includes fill-finish and analytical laboratory capabilities with potential for site expansion -

Horizon Therapeutics plc (Nasdaq: HZNP) today announced that it has reached an agreement to purchase a drug product manufacturing facility from EirGen Pharma, an OPKO Health Company (Nasdaq: OPK) in Waterford, Ireland. The facility, which is located in an IDA Ireland business park, includes a filling line and lyophiliser, or freeze dryer, that can be used for both Horizon’s commercial medicines, including its rare disease biologics TEPEZZA (teprotumumab-trbw), KRYSTEXXA (pegloticase injection) and UPLIZNA (inebilizumab-cdon), and its development compounds.

Horizon will work with Ireland’s Health Products Regulatory Agency (HPRA) and U.S. Food and Drug Administration (FDA) to obtain HPRA and FDA licensure for sterile fill-finish manufacturing and anticipates the first medicine approved for release in approximately two years. As part of the transaction, approximately 40 EirGen employees will transfer to Horizon following the close of the transaction. Horizon intends to recruit 50 additional staff for the site in 2021 and 2022.

“With the successful TEPEZZA launch, ongoing KRYSTEXXA growth and the growth of our marketed medicine portfolio and pipeline, it is the right time to add in-house manufacturing capabilities,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “Adding to our strong network of contract manufacturing organizations, this facility will also play an important role in our global expansion. We look forward to leveraging our existing technical operations expertise in Ireland, along with the expertise of the EirGen employees, to build a robust and effective manufacturing operation that will enable us to meet the unmet needs of people impacted by rare diseases around the world.”

“This is very welcome news,” said Leo Varadkar TD, Tanaiste (Deputy Prime Minister) and Minister for Enterprise, Trade and Employment in Ireland. “The employment will be of significant benefit to Waterford and the broader South East Region. It’s great to see a company with an established presence expanding its Irish operations in a regional location. It demonstrates Horizon’s commitment to Ireland and will allow the company to avail of the rich talent pool in this sector in the region.”

“Horizon is one of the next generation of high-growth biotech companies and this substantial investment is another positive development in Ireland’s growing biopharma industry,” said IDA Ireland CEO Martin Shanahan.

Under the terms of the agreement, Horizon will acquire the facility for a $65 million upfront cash payment. In addition, there is adjacent IDA land available for further manufacturing and development expansion. The transaction, which is subject to customary closing conditions, is expected to close in the third quarter.

Horizon’s global headquarters have been in Dublin, Ireland since 2014 and the company is currently fitting out a new, 62,000 square foot headquarters facility at 70 St. Stephen's Green.

About Horizon

Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Forward Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the expected closing of Horizon’s purchase of the drug product manufacturing facility, Horizon’s expected use of the facility, including expected investments in and regulatory approvals related to the facility, and expectations regarding the retention and hiring of employees at the facility. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the satisfaction of closing conditions related to the transaction, whether Horizon can obtain required regulatory approvals to use the facility for its intended purposes, risks associated with retaining and hiring qualified personnel at the facility, whether additional land will be available for future expansion of the facility and risks associated with the COVID-19 global pandemic. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in those filings. Forward-looking statements speak only as of the date of this press release and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.

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