Horizon Therapeutics plc Announces Short-Term TEPEZZA (teprotumumab-trbw) Supply Disruption Due to Government-Mandated (Operation Warp Speed) COVID-19 Vaccine Production - Seite 2

The Company does not anticipate the short-term supply disruption to impact its full-year 2020 financial guidance, including its previously announced full-year 2020 TEPEZZA guidance of more than $800 million in net sales. The Company expects to have more than $2 billion of cash and cash equivalents at Dec. 31, 2020. The Company also plans to delay the start of its planned TEPEZZA clinical trial in chronic TED and the TEPEZZA exploratory trial in diffuse cutaneous systemic sclerosis until the second quarter of 2021, assuming commercial drug product supplies have normalized by that time. Assuming the chronic TED trial is initiated in the second quarter of 2021, the Company would continue to anticipate data in the first quarter of 2022.

Consistent with past practice, the Company expects to issue 2021 guidance in connection with its fourth-quarter 2020 earnings call when the Company expects to have additional information regarding TEPEZZA supply.

Information for patients
Beginning today, Horizon is delaying new patients starting on TEPEZZA. The Company will be communicating with TEPEZZA patients currently on therapy and the physicians who treat them. The Company’s priority will be to resume therapy for those patients as quickly as possible. If patients have additional questions, please contact Horizon Patient Services at 1-833-469-8331.

Information for healthcare professionals
Physicians with questions should call 1-866-479-6742 [Option 1] or email [e-mail].

Call Information
At 8 a.m. EST/1 p.m. IST today, the Company will host a live webcast to discuss the TEPEZZA supply disruption. The live webcast and a replay may be accessed at http://ir.horizontherapeutics.com. Please connect to the Company's website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

About TEPEZZA

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION
Warnings and Precautions

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.