HORIZON THERAPEUTICS PUBLIC LTD CO : Other Events, Financial Statements and Exhibits (form 8-K)

Item 8.01 Other Events.

On January 21, 2020, Horizon Therapeutics plc announced that the U.S. Food and Drug Administration (FDA) approved TEPEZZATM (teprotumumab-trbw) for the treatment of Thyroid Eye Disease (TED). TEPEZZA is the first and only FDA-approved medicine for the treatment of TED, a serious, progressive and vision-threatening rare autoimmune disease that is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain, inflammation and facial disfigurement. TEPEZZA is a fully human monoclonal antibody (mAb) and a targeted inhibitor of the insulin-like growth factor-1 receptor (IGF-1R) that is administered to patients once every three weeks for a total of eight infusions.

Horizon expects TEPEZZA to be available in the United States in the coming weeks.

On January 21, 2020, Horizon issued a press release announcing the FDA approval of TEPEZZA for the treatment of TED. A copy of this press release is attached hereto as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 Exhibit No.         Description

    99.1               Press release of Horizon Therapeutics plc, dated January 21, 2020.


    104              Cover Page Interactive Data File (embedded within the Inline XBRL
                     document).

Forward-Looking Statements

This report contains forward-looking statements, including statements regarding the timing of TEPEZZA's availability in the United States and the potential benefits of TEPEZZA as a treatment of TED. These forward-looking statements are based on management expectations and assumptions as of the date of this report, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include Horizon's ability to launch TEPEZZA in the United States, whether TEPEZZA is successfully commercialized and adopted by physicians and patients, the extent to which reimbursement is available for TEPEZZA, as well as those 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 report and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law.

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