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 to be on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would 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 the star one. Thank you. I'd like to introduce Beth DelGiacco, Vice President, Global Head of Corporate Communications and Investor Relations. You may begin your conference.

Thank you. A press release was issued earlier today with our first quarter 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 developments, 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 Harmeren, Chief Executive Officer, Carl Zubitz, Chief Financial Officer, and Karen Massey, Chief Operating Officer. I'll now turn the call over to Tim.

Thank you, Beth, and welcome everyone. At the beginning of the year, we shared an ambitious plan to maximize patient impacts over time through our three innovation horizons. First, bringing Zipcar to more patients. by employing a multi-dimensional launch strategy. Second, advancing our clinical pipeline, including M-PASI-PROBART and ARGENIX-119, which have potential across multiple indications with high unmet needs. And third, leveraging our IIP to bring forward the next wave of novel targets to the clinic. Today, I am pleased to share that our execution over the quarter puts us perfectly on track with this plan. Slide four. Let's dive into some of our recent accomplishments, beginning with the team's success in delivering another quarter of solid revenue growth. We now have 7,500 patients on DevGuard and DevGuard Secure globally, which does not include China, where over 2,700 patients started on therapy in the first quarter alone. This means we surpassed the 10,000 patient mark, and we continue to reach new patients and prescribers each quarter, gaining market share among all MG treatments. We had two key drivers of revenue growth in the first quarter. First, we saw a 34% increase in patients on ZGuard SubQ in the US. The majority of these patients were naive to ZGuard, so the subcutaneous product is expanding the market in the way we planned. Second, we saw 46% growth in patients on treatment in Europe, driven by strong demand in Germany and new launches in Italy and Spain. And while it's still early days in the ITP launch in Japan, we are pleased to see patients already start therapy in our second indication. Looking ahead to next month and the expected FDA decision for CIDP, we are making the right choices today with our GMG growth strategy that should serve as well for a CRDP launch in the scenario of an approval. We shared at the beginning of this year that advancing our pre-filled syringe in both GMG and CRDP is a top priority for us, and we have a positive update for you today. We have successfully collected all necessary data points from our bioequivalent and human factor studies and our own track to file with the FDA by the end of June. Our goal is to have the broadest product offering available to patients, recognizing that different patients and prescribers have different treatment preferences. With the pre-filled syringe, we continue to innovate on the patient experience and will seek self-administration in the label, which we expect will help us reach patients earlier in the treatment paradigm. On the clinical front, we made important progress in advancing our next set of indications to Phase III, and now have studies underway in thyroid eye disease and the anti-acetylcholine receptor antibody-negative GMG population. The seronegative study is designed to enable a label expansion into 15 percent of the broader GMG population beyond those patients we can serve today. We are also advancing phase II plans for abgatigumab in Sjogren's and impaciprobar in MMN, based on phase II results in both indications. And we still have additional data readouts ahead this year in PCPOTS and three subtypes of myositis, which you all could jumpstart registration studies, depending on the outcome. The development of our earlier pipeline programs all remain on track, including patient studies of ARGENIX119 and our upcoming INDs across four molecules as we rapidly work to advance the next wave of novel targets.