argenx SE

Good morning. My name is Rob and I will be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you'd like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press star one. Thank you. I'd like to introduce Beth DelGiaco, Vice President of Corporate Communications and Investor Relations. You may begin your conference.

Thank you, operator. A press release was issued earlier today with our first quarter 2023 financial results and a recent business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on slide two that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. Argenix is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Haramaren, Chief Executive Officer, Carl Gubitz, Chief Financial Officer, and Karen Massey, Chief Operating Officer. I'll now turn the call over to Tim.

Thank you, Beth, and welcome, everyone. Flight three. I'm pleased to be here today to share another quarter of strong execution with our global safeguard launch. We continue to deliver results, both in our ability to reach patients and drive revenue, but also with the progress we are making on the regulatory side. We recently announced regulatory approvals in Israel and the U.K., marking our fourth and fifth approvals globally, and we expect more to follow later this year. This is a remarkable achievement from our global submission teams. We are preparing for additional regulatory milestones with the potential approval of SubQ FGATIGAMOP in the United States. Our PDUFA date of June 20 is fast approaching, after which we hope to have the broadest GMG offering for patients, both with an IV infusion and a simple subcutaneous injection. We know that gaining traction in early-line patients will be important for the continued trajectory of our launch, and the approval of a sub-Q product may help us achieve this. I was able to attend the AAN meeting last week where we had a significant presence, demonstrating our long-standing commitment to the neurology community. We had six aspects accepted for presentation, including new data from the ADAPT over-label extension studies, highlighting the consistent efficacy and safety profile of both IV and sub-QL More importantly, we were able to connect with leading neurologists, many who are using DivGuard in their practices.