argenx SE

Good morning. My name is Adam, and I'll be your conference operator today. At this time, I would like to welcome everyone to today's call. 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 would like to ask a question during this time, simply press star followed by one on your telephone keypad. If you would like to withdraw your question, please press star followed by the number two. Thank you. I'd like to introduce Beth DelGiaco, Vice President of Corporate Communications and Investor Relations. You may now begin your conference.

Thank you, Operator. Two press releases were issued earlier today, one which summarizes the positive results from our phase three advanced trial and the other which outlines our first quarter 2022 financial results and business updates. These 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, Luke Troian, Chief Medical Officer, Carl Gubitz, Chief Financial Officer, and Keith Woods, Chief Operating Officer. I will now turn the call over to Tim.

Thank you, Beth. Good morning, everyone, and thank you for joining today's call. Slide three. I'm thrilled to discuss our strong first quarter results. In particular, we have shared two sets of exciting news this morning. First, we have exceeded expectations for the first quarter of our U.S. spacecraft launch, generating 21.2 million in net product revenues. KEEP is going to provide more context on our commercial progress later in the call, but at a high level, this demonstrates both the clear unmet need for new treatments in the GMG community and the tremendous execution of our team to translate that need into real demand from patients and physicians. Our carefully crafted strategies With regards to pay, physicians and patients are paying off today and I'm more confident than ever that we have the right team in place to bring safeguard to the GMG community. We're also on track to launch in Japan this month, so we are advancing well on our global launch strategy. Second, we announced positive results from the advanced trial the first of our two registration ITP trials. We met a very high bar in achieving this positive result with a difficult primary endpoint and a defect-free, very heavily pretreated patient group. We also have a robust set of data from the secondary endpoints that provide additional context on built-in connectivity throughout the study. These data points align closely with how physicians treat ITP patients and will be critical as we look to bring a new treatment option to the ITP community. ITP is now the second serious autoimmune disease in which we've shown a statistically significant treatment benefit. We're starting to see the reality of abdathilumab as a pipeline in a product. I want to spend most of the call on these topics, So I'm going to be brief in talking through the rest of our first course of progress. We reported positive results from the phase three death sub-Q trial and are on track to file by the end of the year. We will build on the positive momentum of our IV launch by bringing additional optionality to patients who may prefer a sub-Q delivery option. We're executing well across all programs and expect by the end of the year to be in a clinical development with 10 F-CAP Tegelman indications and two Avgenix 117 indications, and also to start a phase one trial with Avgenix 119. We saw in our test series that we are expanding enrollment in the ADDRESS trial for PAMFIGUS and therefore push back the timeline for top line results to the second half of 2023. We decided to take a conservative view on our exposure in Ukraine and Russia because we believe it sets us up for the best chance of success with the trial. Ultimately, we want to reach patients as quickly as we can. Of course, we will update you with any changes as we make progress on enrollment. Moving on to the advanced trial results in ITP, Luke will walk through the data in detail but I'd like to first spend a few minutes on why we selected ITP as our second indication and what these positive results could mean for ITP patients. ITP, like all our indications, clearly aligns with our multi-faceted indication selection strategy. First and foremost, the biology rationale is evident. Primary ITP is truly an ITG-mediated serious autoimmune disease in which pathogenic autoantibodies work through four modes of action, as depicted on slide four. We believe that Avgatigamot, with its novel mechanism of action, could be a differentiated approach by targeting all four modes of action simultaneously. This means that we can right-size the balance between enhanced plated production and reduced plated clearance by targeting the autoantibodies driving both modes of action. Second, we pursue rare disease and orphan medications because there is a significant unmet need for new treatment options, and ITP is no different. ITP affects more than 70,000 adults in the United States. This is a disease that affects not only the patient's later count, but is also associated with bruising, bleeding, fatigue, anxiety, and depression. all of which significantly impact the individual's quality of life. The challenge in treating ITP patients is that no defined treatment paradigm exists and physicians have adopted a trial and error approach in which they cycle patients on and off different therapies as one or the other loses effect. We asked our KLLs about the treatment goals for ITP patients and they shared consistent feedback around the need for more options. We're aiming to drive platelets to a safe and sustained platelet level, whether it's 20,000 or 30,000 platelets, while managing bleeding events, and to do this without adding known toxicity to the treatment approach. We kept these goals in mind with a selection of secondary endpoints that we evaluated in advance. We will need to wait for the outcome of the advanced sub-Q trial before we file our DLA, but believe we have a strong data set from the first trial across our primary and secondary endpoints. This puts us on track to deliver a new treatment option to people living with a serious disease. This is a commitment we made to the ITP community. With that, I will hand the call to Liz. to walk through the data in detail.