Horizon Therapeutics plc Announces Short-Term TEPEZZA (teprotumumab-trbw) Supply Disruption Due to Government-Mandated (Operation Warp Speed) COVID-19 Vaccine Production - Seite 3

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and dry skin.

For additional information on TEPEZZA, please see Full Prescribing Information at TEPEZZAhcp.com.

References

1. Barrio-Barrio J, et al. Graves' Ophthalmopathy: VISA versus EUGOGO Classification, Assessment and Management. Journal of Ophthalmopathy. 2015;2015:1-16.

Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to the anticipated impact of recent government orders on TEPEZZA supply, Horizon’s financial and operating results, and planned clinical trials; expectations regarding the length of TEPEZZA supply disruptions; Horizon’s full-year 2020 financial guidance and guidance with respect to 2020 TEPEZZA sales; Horizon’s expected cash position at December 31, 2020; expected financial performance and operating results in future periods; development and commercialization plans; expected timing of clinical trials and results 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 that further TEPEZZA manufacturing run cancellations, whether as a result of additional government orders or other issues at Horizon’s third party manufacturers, or failed manufacturing runs could exacerbate and prolong TEPEZZA supply disruptions; Horizon’s actual future financial and operating results may differ from its expectations or goals; Horizon’s ability to successfully commercialize and grow net sales from existing medicines, including TEPEZZA; uncertainty regarding the impact of the TEPEZZA supply disruption on TEPEZZA’s long-term commercial potential; whether the FDA grants accommodations to alleviate TEPEZZA supply constraints and increase production; impacts of the COVID-19 pandemic and actions taken to slow its spread; risks relating to Horizon’s ability to successfully implement its business strategies; risks inherent in developing novel medicine candidates and existing medicines for new indications; risks associated with regulatory approvals; competition, including potential generic competition; the ability to protect intellectual property and defend patents; 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 press release as a result of new information.