argenx SE

Good morning. My name is Ryan 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 like to introduce Beth DelGiaco, Vice President of Corporate Affairs. You may now begin your call.

Thank you. A press release was issued earlier today with our third quarter 2026 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. ArgenX 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 Executive Officer, Karl Gubitz, Chief Financial Officer, and Sandrine Perret-Girard, Chief Commercialization Officer. Luc Truyen, Chief Medical Officer, will be available during the Q&A. I'll now turn the call to Karen.

Thank you, Beth, and welcome everyone. This has been another outstanding quarter for Argenix. Nearly five years into launch, we're still early in realizing VivGuard's potential across MG and CIDP. And on the heels of positive phase three Alkivia results, we're seeking to bring VivGuard into rheumatology for the first time, with the goal of reaching an entirely new group of patients and prescribers. Beyond VivGuard, we're building what comes next for Argenix. We're advancing in Passapruva towards its first Phase 3 readout in MMN. And we had positive Phase 2 results for FB102 in celiac disease, just months after the Forte acquisition, giving us another Phase 3 ready program. Across our broader pipeline, we expect to have 10 molecules in clinical development by the end of this year. This progress reflects something fundamental about how we innovated our genics. We pursue novel foundational biology that has the potential to make a meaningful difference across multiple diseases of high unmet need. This boldness often has us leading the way, shaping new markets like we have in MG and CIDP, and exploring the boundaries of where a target can have the greatest impact for patients. That's how we're building the next chapter of Argenix, expanding the opportunity for VivGuard while creating new pillars of growth alongside it. It's what gives us confidence in our ability to deliver on Vision 2030 and sustain growth beyond that. As we look ahead, 2027 will be an important year in the evolution of Argenix, with five potential launches across our portfolio. Together, they would mark significant progress towards Vision 2030. In MG, our ambition is for VivGuard to become the treatment of choice across the spectrum of disease. We have a PDUFA date early next year for pediatric MG, and our recent filing in ocular MG could extend Vivgard beyond generalized MG for the first time. In the second half of 2027, we also expect to introduce the Vivgard Hytrulo autoinjector, continuing to elevate the treatment experience across approved indications. Autoimmune myositis is positioned to be the next major area of growth for Vivgard. Alkivia further validated the role of autoantibodies in myositis, demonstrating consistent and clinically meaningful results in both IMNM and DM patients. IMNM is where we have the immediate opportunity and has the greatest unmet need. Patients lose their independence within months, and there are no approved treatments today. We will file an SBLA in IMNM by year-end, for which we have breakthrough therapy designation. We remain committed to securing a label for people living with DM, and based on the strength of the Alkivia data, we are moving with urgency to start an additional registrational study. Now, let me turn to impulsoprubat and MMN, where we are approaching the expected readout of the impassioned study in December. MMN is a serious autoimmune disease that affects 12,000 patients across our key markets. Today, patients depend on IVIG, often spending hours in the infusion chair, and many still experience worsening symptoms over time. We believe impasse-prubat has the potential to offer a differentiated treatment option, both in the outcomes it could deliver for patients and in reducing treatment burden. We have good reasons for this conviction. We believe C2 is the right point in the complement pathway to intervene, above where the damage in MMN starts, and and Pastor Proubart was engineered as a sweeping antibody to efficiently remove C2 and achieve sustained C2 suppression. The Phase II ARDA data gave us meaningful clinical evidence to support this C2 targeting approach. We saw improvements in grip strength and function, together with a substantial reduction in the need for IVIG retreatment. With longer-term treatment, these improvements in grip strength were sustained through 64 weeks. We took those learnings into Impassion, our phase three head-to-head study against IVIG. It's a bold choice to go directly against the current standard of care, but it's one that is grounded in what we know of the biology, the molecule, and the ARDA data. The study asks a very practical question. Can impasse-approved art deliver efficacy comparable to IVIG while reducing the treatment burden? If the answer is yes, that will be meaningful for patients. MMN is only the beginning for impasse-prubat. We believe C2 inhibition has the potential to address a broad range of complement-driven diseases, creating another opportunity to build a pipeline in a product. Beyond our FCRN portfolio and impasse-prubat, our pipeline continues to advance, and FB102 is the latest example of that progress. The positive Phase II results in celiac reinforced our belief in CD122 as a target, and gives us another asset ready to advance into phase three. FB102 has many of the characteristics we look for in a medicine. Novel biology, the opportunity to be first in class in a disease that has seen little innovation and the potential to address multiple autoimmune diseases. Filiac is the most advanced opportunity and the consistency of the phase two results across efficacy measures including symptoms together with this favorable safety profile reinforce the potential we see in the molecule. In 2027, we plan to share more about how we will further unlock the broader pipeline in a product potential of FB102. More broadly, our pipeline is becoming both deeper and more mature. Adam Manabat is advancing to phase three in CMS. Argenix 121 is in phase two in IgA nephropathy. and additional first-in-class molecules are advancing across new mechanisms and disease areas. This breadth is important to our strategy, giving us multiple opportunities to deliver on Vision 2030 while building the foundation for sustainable growth beyond it. With that, I'll turn the call over to Karl.