SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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Item 8.01. Other Events.
On March 30, 2021, Horizon Therapeutics plc (“Horizon” or the “Company”) announced that the U.S. Food and Drug Administration (FDA) has approved a prior approval supplement (PAS) to the previously approved Biologics Licensing Application (BLA) giving Horizon authorization to manufacture more TEPEZZA drug product resulting in an increased number of vials with each manufacturing slot. The Company plans to resupply the market beginning in April, which will end the TEPEZZA supply disruption that began in December 2020 following U.S. government orders prioritizing the manufacturing of a COVID-19 vaccine.
Forward Looking Statements
This report contains forward-looking statements, including, but not limited to, statements related to the anticipated end of the TEPEZZA supply disruption; the timing of availability of TEPEZZA to patients; and business and other statements that are not historical facts. 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, the risk of future supply disruptions, whether as a result of additional government orders or other issues at Horizon’s third party manufacturers; impacts of the COVID-19 pandemic and actions taken to slow its spread; regulatory obligations and oversight, including any changes in the legal and regulatory environment in which Horizon operates and those risks detailed from time-to-time under the caption “Risk Factors” and elsewhere in Horizon’s filings and reports with the SEC. Horizon undertakes no duty or obligation to update any forward-looking statements contained in this report as a result of new information.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Date: March 30, 2021||HORIZON THERAPEUTICS PUBLIC LIMITED COMPANY|
|Paul W. Hoelscher|
|Executive Vice President, Chief Financial Officer|