argenx SE

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. 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 Haramiren, Chief Executive Officer, Carl Gubitz, Chief Financial Officer, and Karen Massey, Chief Operating Officer. Luke Trojan, our Chief Medical Officer, will be available during Q&A. I'll now turn the call to Tim.

Thank you, Beth, and welcome, everyone. I'll begin on slide number three. At the start of the year, we set a bold growth agenda anchored in our long-term roadmap for value creation, Vision 2030. Today, FlipGuard is delivering meaningful impact in two blockbuster indications with MG and CIDP. Our pre-filled syringe is now approved in most major markets, fueling new patient and prescriber adoption. We've also made significant pipeline progress and will enter 2026 with three phase three assets. At the same time, we are investing in our next wave of growth with four new molecules in phase one development by year end and a vibrant immunology innovation program driving future opportunities. Slide four, today I'm joining you from AANEM in San Francisco where we are engaging with the neurology community and sharing new data that reinforce our commitment to continuous innovation in rare neuromuscular diseases. I would like to briefly highlight several key data sets presented this week that underscore our leadership in GMG. ThriftGuard has set a high bar in GMG, driving rapid, deep, and sustained responses. Our gold standard for patient impact is for patients to achieve minimum symptom expression, or MSC, New data from the ADAPT sub-Q study showed that up to 60% of patients reached MSC, with 83% maintaining it for at least eight weeks, highlighting the durability of RevGard responses. We also know that steroid reduction is recognized as a critical outcome for both patients and prescribers. Building on earlier data showing meaningful steroid reductions with RevGard at six months, We now see this sustained through 18 months, with over 55% of safeguard patients reducing steroids to below 5 mg per day. We also present the data from the ADAPT-serum study, which met its primary endpoint, showing significant improvement in MGADL at week 4 compared to placebo. Importantly, we observed increasingly pronounced and clinically meaningful improvements in both MJADL and QMG scores across subsequent treatment cycles, in the overall population, and across all patient subgroups. These positive results support our plan to file for a label expansion that includes all three seronegative subgroups, MUSC positive, LRP4 positive, and triple seronegative. This is a landmark moment in advancing our scientific understanding of MG as the results indicate that pathogenic IgG autoantibodies drive disease regardless of antibody status. Additionally, we continue to showcase the strength of our adhered data in CIDP while introducing new HEOR insights that highlight the severe disease burden, long diagnostic journey, and the urgent need for innovation for these patients. Slide five. We now have three first-in-class molecules in Phase III development, abgartigamot, mpacitrubart, and Nargenix 119, each representing a true pipeline in a product opportunity. We continue to maximize the FCRN opportunity by advancing abgartigamot in severe IgG-mediated autoimmune diseases. while building the future of this target with the next generation of molecules. As we grow our understanding of F-CNN biology, we're building up our capabilities to address patient needs in therapeutic areas beyond neurology. We're also reinforcing our leadership in neurology with M-PASI-PROBART, now in phase three development for MMN and CIDP. With its selective approach, blocking C2 at the intersection of the classical and lectin pathways, and POSIPROBART is uniquely positioned to address a broad range of autoimmune diseases. Lastly, ARGENIX 119, our musk agonist, has now advanced to Phase III in CMS. It is designed to restore neuromuscular junction function, opening the door to indications like ALS and SMA, and underscoring our commitment to pioneering new biology in high unmet need indications. Pipeline and the product molecules are designed with built-in optionality, giving us the flexibility to prioritize indications and allocate resources to programs where we can deliver the greatest patient impact. In line with this strategy, we've made three disciplined development decisions. First, we stopped development of mpaciprobar in dermatomyositis due to operational challenges with study enrollment. That said, DM remains an area of commitment for us. This is a population that has seen little innovation, an unmet need further validated by the strong pace of DM enrollment in our Alkevia study with Avgartigemot. Second, we decided not to advance Avgartigemot into a registration study in lupus nephritis based on the results of the Phase II data. Epgard-Digimod was well tolerated and safety in line with established profile. Third, we are rolling out our next Epgard-Digimod indication, which is Graves' disease. This expands our reach into thyroid-driven autoimmunity and allows us to move directly into Phase III in a disease where there is a high need for a new treatment option. We expect to initiate the registration studies early next year. These are well-informed decisions. to ensure we focus our time and capital on indications where we can deliver the most value. We're also thinking in terms of long-term growth horizons for our core assets, which means that even though we aren't moving forward in certain indications today, we are a data-based company and we'll be ready to revisit our decisions as new evidence emerges. Slide six, the progress we've made positions us for five registration readouts next year. Each reflects our disciplined approach to indication selection, a clear biology rationale, trial designs anchored in robust clinical endpoints, and strong commercial potential to address an unmet patient need. OcularMG will be the first of these in 2026. We've established a strong biologic rationale supported by encouraging ocular domain data from the ADAPT study and real-world case reports. The ocular study will assess the MGII, ocular score, and if successful, could expand our label to include MGFA Class I patients. Myositis and TED studies extend our reach into rheumatology and endocrinology. With myositis, the Phase II portion of the Registrational Alkevia Study demonstrated meaningful improvement in muscle strength and physical function using TIS, which we will evaluate over 52 weeks into phase three. In TED, we're stimulating TSHR autoantibodies drive disease. We leveraged peer data to advance directly into phase three. Across both indications, we see a clear opportunity for VivGuard to deliver differentiated efficacy and safety. MMN will be our first registration readout for mPASI-PROBART. With IVIG as the only available therapy today, there is a significant opportunity to disrupt this market with a novel treatment. In consultation with the regulatory agencies, we've changed the primary endpoint to grip strength, which should capture meaningful functional improvement for patients. Lastly, in ITP, which is already approved in Japan, we designed an efficient confirmatory trial to enable regulatory submission in the U.S. and EU. Translational data continue to show that Avgard Digimod reduces plated destruction and supports plated production and maturation. Slide seven. As part of Vision 2030 and in support of our ambitious goals, we're making investments across our business to ensure long-term sustainable growth. We're actively scaling our operations in the U.S., including an expanded collaboration with Fujifilm through a new manufacturing facility in North Carolina. This move strengthens our global supply chain and supports our manufactured in a region for the region strategy, ensuring we can meet growing demand for safeguard and future pipeline therapies. At the same time, we're investing our pipeline innovation engine doubling down on our pursuit of novel biology because this playbook is working. We remain on track to have four new pipeline assets in phase one by year end, with more expected to advance from our 20 active IIP programs, each representing a potential breakthrough in immunology. With that, I will now turn the call over to Karl.

Thank you, Tim. Slide eight. The third quarter 2025 financial results are detailed in this morning's press release. We are proud to report an outstanding quarter, reflecting exceptional execution and sustained momentum in our business. In the third quarter, we reported total product net sales of $1.13 billion, marking a historic milestone for Argenix as we surpassed for the first time $1 billion in safeguard sales in a single quarter. We achieved growth of 19% or $178 million in product net sales when comparing to the previous quarter of this year, and 96% of $554 million in growth when comparing free Q on a year-over-year basis. If you look at the breakdown by region, Product net sales were $964 million in the US, $60 million in Japan, $94 million across our rest of the world markets, including our partner markets, and $9 million for product supply to Xilab in China. The product net sales in the US specifically grew by 20% quarter over quarter, reflecting the impact of our investments in the PFS launch earlier this year. PFS is now firmly established as a growth driver in your markets, supporting our continued momentum in GMG and CIDP. The growth to net adjustments in Q3 and the net pricing in the US are in line with the prior quarter. Next slide. Total operating expenses in the third quarter are $805 million, representing a 5% increase compared to the second quarter. Our R&D expenses increased by 9%, or $28 million, and our SG&A expenses by 4%, or $11 million. Building on our solid revenue performance, we continue to invest in our growth opportunities. Therefore, expect our expenses to continue to grow in the single digits for the rest of the year. This will result in your combined R&D and SG&A expenses to land just north of $2.5 billion at between $2.6 billion and $2.7 billion. Cost of sales of a quarter is $109 million. Our year-to-date gross margin remains consistent at 11%. Our operating profit for the quarter is $346 million and the quarterly financial income is $43 million, which results in profit before tax of $386 million. The year-to-date effective tax rate is 13%. After tax, the profit for the quarter is $344 million and $759 million on a year-to-date basis. Our cash balance at the end of the quarter, represented by cash, cash equivalents, and current financial assets, is $4.3 billion, which represents a nearly $1 billion increase in cash since the beginning of the year. I will now turn the call over to Karen, who will provide details on the commercial front.