#ANDY PASTERNAK HORIZON THERAPEUTICS TRIAL#

We also expect to have data from our MIRROR open label pilot trial in early 2020.

#ANDY PASTERNAK HORIZON THERAPEUTICS REGISTRATION#

With KRYSTEXXA, in addition to the quarter’s strong commercial performance, we continued enrolling our MIRROR placebo-controlled registration trial and launched PROTECT trial to evaluate the use of KRYSTEXXA in kidney transplant patients with uncontrolled gout. We also present additional Phase 3 trial data at several medical meetings while making significant progress in our pre-launch activities. We submitted our BLA for teprotumumab and received Priority Review designation with the MaPDUFA date. We reached several key milestones during the third quarter. This underscores the significant margin expansion we are driving from our underlying business. Excluding our significant teprotumumab launch investment year-over-year adjusted EBITDA growth would be double digits at the midpoint. We increased the midpoint of our full-year adjusted EBITDA guidance range as well.

We generated another strong quarter with our Orphan and Rheumatology segment up 14%, driven by KRYSTEXXA growth of 42%. Thank you, Tina, and good morning, everyone. These non-GAAP financial measures are reconciled with the comparable GAAP financial measures in our earnings press release and other filings from today that are available on our Investor website at I will now turn the call over to Tim. In addition, on today’s conference call, non-GAAP financial measures will be used.

#ANDY PASTERNAK HORIZON THERAPEUTICS UPDATE#

You are cautioned not to place undue reliance on these forward-looking statements, and Horizon disclaims any obligation to update such statements. These statements are subject to various risks that are described in our filings made with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2018, subsequent quarterly reports on Form 10-Quarter, and our earnings press release, which we issued this morning. We’ll then take your questions.Īs a reminder, during today’s call, we’ll be making certain forward-looking statements, including statements about financial projections, our business strategy and the expected timing and impact of future events. Shao-Lee will provide a review of our R&D programs, and Paul will discuss our financial performance and guidance, followed by closing remarks from Tim. He will also discuss in greater detail our prelaunch preparations for teprotumumab, our first-in-class biologic under FDA review for thyroid eye disease or TED. Tim will provide a high level review of the third quarter and an update on our business. On the call with me today are Tim Walbert, Chairman, President and Chief Executive Officer Shao-Lee Lin, Executive Vice President, Head of Research and Development and Chief Scientific Officer Paul Hoelscher, Executive Vice President, Chief Financial Officer Vikram Karnani, Executive Vice President, Chief Commercial Officer and Andy Pasternak, Executive Vice President, Chief Business Officer. Good morning, everyone, and thank you for joining us. Tina Ventura, Senior Vice President of Investor Relations. As a reminder, today’s conference is being recorded.

Welcome to Horizon Therapeutics’ PLC Third Quarter 2019 Earnings Conference Call. Good morning and thank you for standing by. Vikram Karnani - EVP and Chief Commercial OfficerĪndy Pasternak - EVP Chief Business Officer Shao-Lee Lin - EVP, Head, R&D and Chief Scientific Officer Tim Walbert - Chairman, President and CEO Horizon Therapeutics plc ( NASDAQ: HZNP) Q3 2019 Results Conference Call Novem8:00 AM ET

Andy pasternak horizon therapeutics