Form 8-K

Date: July 30, 2019

HORIZON THERAPEUTICS PUBLIC LIMITED COMPANY

/s/ Paul W. Hoelscher

Paul W. Hoelscher

Executive Vice President and Chief Financial Officer

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): July 30, 2019

Horizon Therapeutics Public Limited Company

(Exact name of registrant as specified in its charter)

Ireland

001-35238

Not Applicable

(State or other jurisdiction

of incorporation)

(Commission

File No.)

(IRS Employer

Identification No.)

Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

(Address of principal executive offices)

Registrant’s telephone number, including area code: 011-353-1-772-2100

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Ordinary shares, nominal value $0.0001 per share	HZNP	The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01.

Other Events.

On July 30, 2019, the Federal Circuit Court of Appeals denied Horizon Therapeutics plc’s (the “Company”) request for a rehearing of the Court’s invalidity ruling against the 6,926,907 and 8,557,285 patents for VIMOVO (naproxen and esomeprazole magnesium) coordinated-release tablets. As a result, the Company expects the District Court to enter judgment against the Company, which could subsequently result in Dr. Reddy’s initiating an at-risk launch of a generic version of VIMOVO. If Dr. Reddy’s launches a generic version of VIMOVO, the Company does not expect it would have any material impact to its 2019 guidance. Ongoing patent litigation between the two companies continues, including a separate court case involving Orange Book-listed patents expiring in May 2022.

Forward Looking Statements

This report contains forward-looking statements, including, but not limited to, statements related to the decision of the Federal Circuit Court of Appeals and potential outcomes resulting therefrom, including the possibility of Dr. Reddy’s launching a generic version of VIMOVO and any impact such launch may have on the Company’s 2019 guidance. These forward-looking statements are based on the Company’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 possibility that the launch of a generic version of VIMOVO has unexpected impacts on the Company’s financial results. Additional risks and uncertainties relating to the Company and its business can be found under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, and its subsequent filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date of this report, and the Company undertakes no duty or obligation to update any forward-looking statements contained in this report as a result of new information, future events or changes in its expectations.

SIGNATURES

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.