Horizon Therapeutics Plc - HZNP STOCK NEWS

Horizon Therapeutics plc (Nasdaq: HZNP) announced the retirement of CFO Paul Hoelscher effective May 16, 2022, with Aaron Cox succeeding him. Hoelscher has been with Horizon since 2014, playing a crucial role in the company's growth. Cox, who joined Horizon in 2016, has led various strategic initiatives, including the Viela Bio acquisition. His extensive experience in corporate development and finance is expected to support Horizon's long-term strategy. Forward-looking statements regarding executive transitions and business growth were included, highlighting possible risks and uncertainties.

Horizon Therapeutics reported record third-quarter 2021 results with net sales of $1.037 billion, a 63% increase year-over-year. GAAP net income reached $326.5 million, and adjusted EBITDA was $509 million. Third-quarter net sales for TEPEZZA were $616.4 million, and for KRYSTEXXA, $158.1 million. The company raised its full-year 2021 net sales guidance to between $3.16 billion and $3.21 billion, representing approximately 45% growth at the midpoint. Horizon also announced five new R&D programs and positive results from the KRYSTEXXA MIRROR trial.

Horizon Therapeutics announces survey results indicating a negative stigma surrounding gout treatment among rheumatologists. The study, conducted with 106 practicing specialists, reveals that gout patients are perceived to have lower treatment compliance and worse outcomes than those with rheumatoid arthritis. Additionally, new analyses presented at the American College of Rheumatology Convergence 2021 highlight the benefits of using KRYSTEXXA (pegloticase injection) in conjunction with immunomodulation, achieving a 90% target serum uric acid level in patients. This evidence aims to improve clinical outcomes for uncontrolled gout patients.

Horizon Therapeutics plc (NASDAQ: HZNP) announced significant results from the MIRROR trial, demonstrating a 30 percentage point increase in response rates for chronic gout patients treated with KRYSTEXXA combined with methotrexate. Specifically, 71% of patients using this combination achieved treatment success compared to 40% for those receiving KRYSTEXXA with placebo (p<0.001). Horizon plans to file a Supplemental Biologics License Application (sBLA) with the FDA in Q1 2022, aiming to enhance treatment options for uncontrolled gout patients.

Horizon Therapeutics announced long-term efficacy results of TEPEZZA for Thyroid Eye Disease (TED) from the OPTIC-X trial, published in Ophthalmology. The trial indicated a 90.6% response rate for proptosis at Week 48 among patients previously treated with placebo. Additionally, 90% of OPTIC patients who completed the follow-up required no additional therapy. No new safety concerns were reported, supporting TEPEZZA's role in managing this serious autoimmune disease. This data enhances understanding of treatment longevity for TED patients.

Horizon Therapeutics plc (NASDAQ: HZNP) announced significant findings from the Phase 2/3 N-MOmentum trial of UPLIZNA, presented at ECTRIMS 2021. The analysis indicates a strong correlation between deep B-cell depletion and improved outcomes in patients with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder (NMOSD). UPLIZNA achieved a 97% reduction in annualized attack rates and a 73% decrease in new lesions compared to placebo. These results underscore the role of B cells in NMOSD and support UPLIZNA's efficacy in managing the condition.

Horizon Therapeutics plc (NASDAQ: HZNP) announced significant data presentations for TEPEZZA at the American Academy of Ophthalmology Annual Meeting from Nov. 12-15, 2021, in New Orleans. TEPEZZA is the first FDA-approved medication for Thyroid Eye Disease (TED), which poses serious risks to vision. Key presentations will cover real-world adherence to TEPEZZA and efficacy in TED patients with low inflammation. Horizon will also host a product theater discussing real-world cases in TED.

Horizon Therapeutics plc (Nasdaq: HZNP) is set to release its third-quarter 2021 financial results on November 3, 2021, at 8 a.m. Eastern Time. Following this, a live webcast will be available for management to discuss the financial and operational outcomes. Investors can access the webcast via Horizon's investor relations website. Horizon focuses on developing treatments for rare, autoimmune, and severe inflammatory diseases, emphasizing the integration of science and compassion to profoundly impact patients' lives.