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. Thank you. I'd now like to introduce Beth DelGiaco, Vice President of Corporate Affairs. You may now begin your conference.

Thank you. Two press releases were issued earlier today, one sharing the positive results from our phase three ADAPT Oculus study, and the other which outlines our fourth quarter and full year 2025 financial results and business update. These can be found on our website along with the presentation for today's webcast. Before we begin on slide two, I'd like to remind you 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 Karen Massey, Chief Operating Officer, Carl Gubitz, Chief Financial Officer, Luke Trojan, Chief Medical Officer, Sandrine Piret-Girard, Chief Commercialization Officer, and Tim Van Harenmeren, Chief Executive Officer. I'll now turn the call over to Karen.

Thank you, Beth, and welcome, everyone. I'll begin on slide three. 2025 was an incredible year of execution for iGenX. We reached 19,000 patients globally, driven in part by the successful launch of our pre-filled syringe for self-injection. We also continue to advance our deep and differentiated immunology pipeline, including four new molecules from our IIP, positioning us for sustained long-term growth. This progress is grounded in our commitment to patients to innovate in ways that don't just improve care, but meaningfully change what patients can expect from their treatment. I'm speaking to you today from our US national team meeting, where hearing directly from patients is a powerful reminder of why our work matters. One moment in particular stayed with me. We recently received a handwritten note from a patient, thanking the team for the impact Vivgard has had on her life. We later learned that before starting treatment, she had been living with very severe MG symptoms that significantly limited her day-to-day activities. Today at the meeting, we saw a video of the patient about a year into treatment with VivGuard Hiketrulo, sharing an update from a hike she was on. She is thriving. It's one individual story, but it reinforces the real-world difference VivGuard can make. Slide four. At the start of the year, we outlined our strategic priorities for 2026 that will guide our next chapter of growth towards Vision 2030. We want to impact more patients globally with VivGuard through broader patient adoption and label expansion. We're shaping the future of FCRN medicines with next-generation molecules, delivery modalities, and combination approaches, and delivering the next wave of immunology innovation supported by a strong late-stage portfolio and a goal of at least one new pipeline candidate per year. Slide five. VivGuard is leading the growth of biologics in both MG and CIDP, and we're confident that we have the right strategies and milestones ahead to sustain this momentum. Today marks an exciting moment for ocular MG patients with the positive ADAPT Oculus results, which Luke will discuss shortly. Together with our progress in seronegative MG, we see a meaningful opportunity to broaden VivGuard's reach to patients who have historically had limited or no targeted treatment options. What's guided us here is a longstanding commitment to the MG community and to advancing our understanding of the underlying biology of the diseases we treat. Across MG populations, our data confirm that disease is driven by pathogenic IgGs, regardless of antibody status. In seronegative MG, we demonstrated a clinically meaningful improvement in MG ADL in the overall population, with responses becoming more pronounced with subsequent treatment cycles across all subtypes. In ocular MG, we're seeing that same biology extend to another patient population, with VivGuard meeting its primary endpoint and driving clear improvements in ptosis and diplopia. Our seronegative PDUFA day is May 10th, and based on today's results, we see a clear path to expanding our label into ocular MG as well, positioning VivGuard to have the broadest MG label and to reach our target addressable population of approximately 60,000 patients in the U.S. In CIDP, we're also having a meaningful impact on patients with clinical data showing functional improvement and these benefits increasingly reflected in real-world experience. VivGuard is driving a paradigm shift in CIDP. While there remains significant opportunity within the initial 12,000 addressable patient population, we're also beginning to see expansion beyond that population, a core focus as we build leadership in CIDP. Sandrine will speak more to this later in the call. Slide six. Over the next 12 to 18 months, we have multiple avenues for expansion beyond MG and CIDP, including autoimmune myositis and Sjogren's disease, which broadens ISGAR's footprint into rheumatology. In particular, our work in IMNM highlights a significant unmet need with an estimated 20,000 patients and no approved treatment options today. Meanwhile, our upcoming Q4 readout for impasse-approved body in MMN marks an important milestone, positioning us to advance a second medicine to patients and extending our neurology footprint with a first-in-class C2 inhibitor. We have an opportunity to address a clear unmet need in MMN with IVIG as the only approved treatment and symptom progression in 60% of patients. Slide seven. Lastly, we continue to strengthen the pipeline that will shape our long-term future. VivGuard is just the beginning of FCRN leadership that we aim to establish for decades to come. As part of this, we're advancing two next-generation assets, Argenix 213 and Argenix 124. We're investing in FGAR-Tigamod-anchored combination approaches and new delivery modalities like the auto-injector and oral peptide capabilities. At the same time, we're seeing real momentum across our broader innovation platform, progressing first-in-class molecules like Argenix 121, targeting IgA, and Argenix 118, targeting Galactin 10. We are deliberately source agnostic in how we identify new biology during for both leading academic research and opportunities emerging within biopharma. In 2026, we expect to progress three phase one programs, including a program from our Tensegrity collaboration, reinforcing our ability to bring forward high quality science wherever it originates. We have an exciting year ahead of us with a strong foundation in place and exciting progress across the pipeline. Let's turn to the data that's shaping our next steps. Luke?