Horizon Pharma plc (NASDAQ:HZNP) Q3 2019 Earnings Conference Call - Final Transcript
Nov 06, 2019 • 08:00 am ET
Good morning and thank you for standing by. Welcome to Horizon Therapeutics' PLC Third Quarter 2019 Earnings Conference Call. [Operator Instructions]. I would now like to introduce Ms. Tina Ventura, Senior Vice President of Investor Relations.
Thank you, Catherine. Good morning everyone and thank you for joining us. 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 and Chief Business Officer. Tim will provide a high level review of the third quarter and an update on our business. He will also discuss in greater detail our pre-launch preparations for Teprotumumab, our first-in-class biologic under FDA review for thyroid eye disease or TED. 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, we'll then take the questions.
As 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. 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 31st, 2018. Subsequent quarterly reports on Form 10-Q and our earnings press release which we issued this morning.
You are cautioned not to place undue reliance on these forward-looking statements and Horizon disclaims any obligation to update such statements. In addition, on today's conference call non-GAAP financial measures will be used. 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 www.horizontherapeutics.com.
I will now turn the call over to Tim.
Thank you, Tina and good morning everyone. We generated another strong quarter with our Orphan and Rheumatology segment up 14% driven by KRYSTEXXA growth of 42%, we increased the midpoint of our full-year adjusted EBITDA guidance range as well. Excluding our significant Teprotumumab launch investment year-over-year adjusted EBITDA growth would be double-digits at the midpoint. This underscores the significant margin expansion we are driving from our underlying business.
We reached several key milestones during the third quarter. We submitted our BLA for Teprotumumab and received Priority Review designation with the March 8, 2020 PDUFA date. We also present additional Phase III trial data at several medical meetings, we're making significant progress in our pre-launch activities. 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 and it could be transplant patients with uncontrolled gout.
We also expect to have data from our MIRROR open label pilot trial in early 2020. We reduced our gross debt and brought