argenx SE

to prevent any background noise. After the speaker's remarks, there will be a question. Issued earlier today with our half-year 2025 financial results and second quarter business update. This can be found on our website along with the presentation for today's webcast. Before we begin on slide 2, 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. Our GenX 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, Karl Gubitz, Chief Financial Officer, and Karen Massey, Chief Operating Officer. Luke Trojan, Chief Medical Officer, will be available during the Q&A. I'll now turn the call over to Tim.

Thank you, Beth, and welcome, everyone. I'll begin on slide number three. Vision 2030 is our roadmap for long-term value creation, and I'm proud to say that we are exactly where we set out to be. Over the past 12 months, Prisgard has achieved exceptional year-over-year growth of 97% across all of its approved indications. We've also initiated multiple registration trials in large market opportunities like Sjogren's, myositis, and TED, and advanced four new molecules into our pipeline. This sets us up to create significant growth with 10 labeled indications and a robust late-stage pipeline by 2030. While we are building for the long term, we're also delivering today. 15,000 patients globally are now being treated with VIVGARPS, including 2,500 CRDP patients just one year into the launch. We are seeing growth across all indications, formulations, and regions, And as expected, our pre-filled syringe is already driving new patient starts and new prescriber demands. This momentum is a direct result of our team's extraordinary execution, and I want to thank them for advancing innovation that truly matters to patients. Karen will share more later in the call on our commercial performance and the path to reach 50,000 patients by 2030. What I want to focus today is on the opportunity we have to expand WIVGAR's broad potential and advance our pipeline of first-in-class assets. Slide 4. We have the opportunity to create significant value in the near term with our three Phase III pipeline assets. We're building momentum with Edgar Piguemot in therapeutic areas beyond neurology. we presented our Phase II proof-of-concept results in myositis and Sjogren's for the first time at DULAR, and the reception from the rheumatology community reminds me of the early enthusiasm we saw from neurologists when we first unveiled our NG data. Rheumatologists are beginning to see what a targeted approach like Evgatigamot could mean for their patients, raising the treatment bar beyond symptom management to a sustained functional improvement. In the myositis study, I've got significant improvement in muscle strength as measured by the test, which clinically merit what we saw preclinically in our mouse passive transfer models. In the Sjogren's study, we observed meaningful improvement in systemic disease activity. EMPASI-PROBART is also advancing in two registrational head-to-head studies versus IVIG in MMN and CIDP. Our decision to run head-to-head studies illustrates our conviction that EMPASI-PROBART has the potential to disrupt these markets. The Phase II ARDA results in MMN support us and recently gained significant attention from treating neurologists at PNS in May. The data point that resonated most comes from the patient global impression of change scale, where over 94% of treated patients felt better on EMPA than their best on IVIG, indicating EMPA could provide a transformative benefit. For CIDP, we are seeing the significant demand from the community from VivGuard HyTRU law, indicating that there is still a need for more innovation. We're committed to making the broadest impact by advancing two distinct mechanisms of action with VidGaR and EMPASI-PRUBART. Argenix 119 is our third and most recent molecule to enter a registrational study following positive proof of biology data in CMS. The discovery and development of Argenix 119 exemplifies our innovation model well. We collaborated with the world's leading experts to design an antibody that activates musk in a way that stabilizes and potentially enhances the neuromuscular junction. In our 16-patient phase 1 CMS study, we observed consistent functional improvements across multiple endpoints. And this is just the beginning for IGENX119. We have identified several opportunities across neurology for this agonistic antibody. Flight 5, our immunology innovation platform continues to be a powerful engine for long-term growth. We are rapidly advancing four new molecules, including our IL-6 inhibitors, a second FcRn blocker, and an IgA-targeting antibody, all of which are now in Phase I studies. These programs are part of our broader portfolio of over 20 active IIP programs each targeting areas of high unmet need. Our approach starts with identifying novel, first-in-class immunology targets and building molecules that address them. As part of our investment in our IIP, we are also expanding our toolbox to optimize our molecules to be best-in-class. We recently announced a collaboration with a natural product to gain access to that AI-driven microcycle discovery platform, enabling the development of potent, selective, and orally available peptides against targets that we select. This collaboration both expands our capabilities beyond antibodies and reinforces our commitment to continue to innovate on the patient experience. I will now turn the call over to Karl to discuss our strong financial position which remains a key lever for us in achieving our long-term growth vision to scale efficiently and prioritize our investment in innovation.

Thank you, Tim. Slide six. The second quarter 2025 financial results are detailed in this morning's press release. Total operating income in the second quarter was $967 million. This reflects $949 million in product net sales and $19 million in other operating income. We are very proud of a 97% growth we have been able to deliver since this time last year, representing the significant unmet need that exists in MG and CIDP and the transformative outcomes VivCard can offer to patients. On a quarter-over-quarter basis, we delivered 19% or $158 million in product net sales growth in second quarter compared to first quarter of this year. If you look at the breakdown by region, product net sales were $802 million in the US, $52 million in Japan, 83 million across our rest of world markets, including Europe, Canada, and our partner markets, and 12 million dollars for product supply to Xilab in China. We are happy to share, but all global markets grew in the second quarter, with the exception of our supply to China. which you'll remember is not reflective of demand and depends on when we ship within the quarter. We continue to expand our patient reach in our non-US markets, and the overall contribution of these regions now represents more than 15% of our global product net sales. In the US specifically, we delivered 18% quarter-over-quarter growth which reflects strong growth in both GMG and CIDP across all three presentations, birth cart IV, sub-Q vial, and the sub-Q pre-fold syringe. We made the investment to move quickly with PFS because we know it will be a long-term growth enabler for all current and future indications. We are already seeing this play out in the near term and PFS has increased patient demand for VivCard one quarter into its launch. With the introduction of PFS and the changing dynamics associated with Medicare Part D redesign, there was an increase in gross to net, which we anticipated. Gross to net went from 12% at the end of 2024 to approximately 20% at the end of the second quarter. Importantly, the net revenue contribution for a GMG patient and a CIDP patient continues to be consistent with our previous guidance. This means that going forward, even with the increased gross to net adjustments, Growth will be driven by our ability to broaden our patient reach within the MG and CIDP markets and into new patient populations. PFS will help us to achieve this growth. Next slide. Total operating expenses in the second quarter are $766 million, an increase of $98 million compared with Q1. This includes a $49 million increase in SG&A and a $19 million increase in R&D, all of which reflects our commitment to deliver on our innovation mission in a disciplined way. Cost of sales for the quarter is $111 million, which brings our year-to-date gross margin to 11%. We continue to make important investments into our global supply chain. Our expansion strategy includes our commitment to manufacture in a region for that region and specifically to grow our capacity in the US. R&D and SG&A expenses for Q2 were $328 million and $325 million, respectively. leading to an operating profit $201 million for the period. The quarterly financial income is $38 million, and we recorded $49 million of exchange gains, mainly resulting from your non-U.S. dollar denominated cash balances. The year-to-date effective tax rate is 15%. After tax, the profit for the quarter is $245 million, and for the year to date is $415 million. Now cash balance at the end of a quarter represented by cash, cash equivalents, and current financial assets is $3.9 billion. This is up from $3.4 billion as of the beginning of the year, mainly driven by net cash flow from operating activities of $0.4 billion for the first half of the year. I will now turn the call over to Karen, who will provide details on the commercial front.