X4 Pharmaceuticals, Inc. (NASDAQ:XFOR) Q3 2023 Earnings Conference Call November 9, 2023 8:30 AM ET
Company Participants
Dan Ferry – LifeSci Advisors
Paula Ragan – Chief Executive Officer
Mark Baldry – Chief Commercial Officer
Christophe Arbet-Engels – Chief Medical Officer
Adam Mostafa – Chief Financial Officer
Conference Call Participants
Eva Privitera – TD Cowen
Stephen Willey – Stifel
Edward Tenthoff – Piper Sandler
Andy Fleszar – B. Riley Securities
Kristen Kluska – Cantor Fitzgerald
Swayampakula Ramakanth – H.C. Wainwright
David Bautz – Zacks Small Cap Research
Operator
Greetings and welcome to X4 Pharmaceuticals’ Third Quarter Financial and Operating Results Conference Call. At this time all participants are in a listen-only mode. [Operator Instructions] As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host, Dan Ferry from LifeSci Advisors. Thank you, Mr. Ferry. You may begin.
Dan Ferry
Thank you, operator, and good morning, everyone. Presenting on today’s call will be X4’s Chief Executive Officer, Dr. Paula Ragan; Chief Commercial Officer, Mark Baldry; and Chief Medical Officer, Dr. Christophe Arbet-Engels.
Following the prepared remarks by each, we will open up the call to your questions and will be joined by Chief Financial Officer, Adam Mostafa; Chief Scientific Officer, Art Taveras; and Chief Operating Officer, Mary DiBiase.
As a reminder, on today’s call, the company will be making forward-looking statements regarding regulatory and product development plans as well as research activities. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. Description of these risks can be found in X4’s most recent filings with the SEC, including this quarter’s Form 10-Q, which is expected to be filed after market close today.
I’d now like to turn the call over X4’s President and CEO, Dr. Paula Ragan. Paula?
Paula Ragan
Thanks, Dan. Good morning everyone, and thank you for joining us on the call today. To start, I’ll be reviewing our third quarter events and recent highlights, the first two of which will be the primary focus of our discussion today. As you can see here, it’s again been a very busy and productive period at X4, which culminated in the great news last week that our NDA seeking approval of our lead drug candidate mavorixafor, for the treatment of WHIM syndrome, was accepted by the FDA for Priority Review.
The FDA has set a PDUFA, or action date, of April 30, 2024, which sets us up for a potential second quarter 2024 launch in the U.S. if approved. In anticipation of this, we have continued to build out our fit-for-purpose commercial organization. Mark Baldry, our Chief Commercial Officer, will run through some of the details of our launch readiness and pre-launch activities to date, all of which aim to further the understanding of WHIM syndrome and educate both patients and physicians on the importance and benefits of early diagnosis.