argenx SE

Thank you. A press release was issued earlier today with our third quarter 2024 financial results and 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 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 confirm these statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Haren, Chief Executive Officer, Harald Lubitz, Chief Financial Officer, and Karen Massey, Chief Operating Officer. I will now turn the call over to Tim.

Thank you, Beth, and welcome, everyone. I'll begin on slide number three. As we approach the end of 2024, it is incredible to reflect on all that we have accomplished, having achieved the goals set out in our 2025 vision ahead of plan. We moved to goalposts again in July, raising our ambition with vision 2030. Building on the momentum from R&D day, we are now executing across the business to advance this vision, beginning with our commercial expansion. This is our 11th consecutive quarter of growth, and I continue to be impressed with the team's efforts to reach more GMG patients and prescribers and build our wall of data in support of VivGuard as the leading branded biologic in MG. The CIDP launch has started strong as we leverage the powerful data from Adheave and our established relationships with payers and prescribers to support a quarter that surpassed our expectations. Overall, we are thrilled with our initial progress, bringing innovation to CIDP patients. CARA will provide metrics that highlight the positive reception of Descartes Hydrulo across key stakeholders, but overall, we're very happy with our strong start. We are navigating the unique market dynamics of CIDP well, and we're able to deliver our innovation to more than 300 CIDP patients last quarter, which correlates to revenue that is approaching what we saw in the first quarter of our MG launch. Slide four, we now have the benefit of seeing the adhered data drive real-world outcomes with some patients already experiencing regain of function early into their treatment journey. My personal favorite story comes from the first CIDP patient dosed with Vivcar Hytrulo. The patient's wife shared that prior to treatment, her husband struggled with mobility. He recently checked in and the patient is now more active. He and his wife have enjoyed traveling again and were able to attend a friend's wedding. He has now been able to take care of himself more independently and is eager to return to activities he loves like golfing and going to the gym. The wife of the patient expressed her gratitude for this renewed lease on life. This is the type of story that makes this industry so rewarding. Slide five. Earlier this month, we had a strong presence at ANEM where we were able to present new clinical trial and real-world data demonstrating our long-term commitment to the neurology community and driving transformational outcomes for patients. We continue to set a high bar with VidGuard, driving rapid, deep, and sustained responses. And now we have multi-year data demonstrating durable efficacy supporting maintenance use. Over 50% of GMG patients on DivGuard achieve MSC, which physicians agree is an important goal of treatment for their patients, and we hear the speed of onset is a clear advantage. We now have more than 8,000 patient years of safety data, which demonstrate consistent, favorable safety. No black box warning, no impact on albumin levels, no REMS program, no monitoring requirements, and no need to vaccinate. Consistent with our goal to bring DIPCARD into earlier lung treatment settings, we also presented new real-world data that patients can meaningfully reduce steroids use within six months of treatment. This effect was maintained and improved through 12 months, with one out of four patients taping to zero milligram of steroids, and 42% of patients tapering to 5 milligram or less. ANEM was notably the first congress where we showcased preclinical programs from our pipeline, including MPALCIPROBARC and ARGENIX 119. Through these programs, we continue to solidify our leadership in neuromuscular medicine, advancing clinical development across multiple indications, including MG, CIDP, MMN, CMS, and ALS. and generating early excitement as we address unmet needs with our precision medicines. Slide six. Before turning the call over to Carl, I would like to highlight some of the opportunities ahead to advance innovation as we approach the end. Remember, we like novel targets with pipeline in a product potential and seek out indications where we believe we can drive the most impact for patients. Indications continue to mature across our three pipeline programs in the clinic. Gartigimot, Emposipropart, and Algenics 119. Next up is our myositis go-no-go decision before year end. As you may recall, we thoughtfully designed Alkevia as our first basket study that would allow us to simultaneously evaluate a Gartigimot in three subsets of myositis, necrotizing, antisynthetase, and dermatomyositis. The primary endpoint of the study is the same across all subsets and is based on the total improvement score. With the CMS Phase 2-3 design, we started enrolling in the Phase 3 as soon as we completed enrollment in the Phase 2, which means that the decision we will make in the coming weeks is whether we will continue recruitment in one or more subsets based on the signal we see in the first 90 patients from the Phase 2. Lastly, as you saw in today's release, we made a decision to discontinue the development of abgartigamot in MN. As a part of our strategic alliance with Xylab, we are leveraging Xy's clinical development in MN and Allen to kidney indications prevalent in China. We did not see a sufficient efficacy signal from the interim data to warrant further investment in MN. Importantly, no safety signals were detected And now we look forward to the Phase 2 data in LN. It is part of our mission to prioritize programs that have the potential to drive transformational outcomes in patients. And we do not see this opportunity without Gatig & Mod in MN. To close, we are well positioned to continue investing in our innovation, advancing high-value novel treatments that can improve outcomes for patients and maximize value for shareholders. I will now turn the call over to Karen.

Thank you, Tim. Slide 7. The third quarter 2024 financial results are detailed in the press release of this morning. Total operating income in the third quarter totals $589 million. This reflects $573 million in product net sales and $16 million in other operating income. The product net sales of $573 million represent 20% quarter-over-quarter growth and 74% growth compared with a corresponding prior year quarter. The product revenue breaks down by region to $492 million in the U.S., $24 million in Japan, $46 million in the rest of the world, and $11 million for product supply to Xilab in China. The net sales in the U.S. is inclusive of both CIDP and MG revenue. Karen will provide additional color in her section on the initial launch performance. Slide eight. Total operating expense in Q3 are $575 million, an increase of $40 million compared with Q2 2024. The increase is due to a $22 million increase in SG&A reflecting incremental expenses on the CIDP launch in the U.S., an $11 million increase in R&D, and an increase of $7 million in cost of sales. Cost of sales is $59 million in Q3. This reflects a gross margin of 90%, which is in line with previous quarters. In Q3, SG&A expenses are $278 million, and R&D expenses are $236 million. This results in operating profit for Q3 of $14 million. On a year-to-date basis, operating loss is $125 million. For quarterly, net financial income is $41 million, and it also benefits from unrealized exchange gains of $34 million on our Euro-denominated cash balances. After-tax, the profit for the quarter is $91 million, and the year-to-date profit after-tax is $59 million. Our cash balance, represented by cash, cash equivalents, and current financial assets, is $3.4 billion at quarter end. The balance increased by $272 million in the quarter, and our cash guidance for 2024 no longer applies. The financial guidance on the combined SG&A and R&D spend of $2 billion remains unchanged. I will now turn the call over to Karen, who will provide details on the commercial front.