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A press release issued earlier today with our fourth quarter and a full year 2024 financial results and business update. This 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 development, regulatory timeline, 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 these statements in relation to actual results. Unless required by law. I'm joined on the call today by Timba Haramiran, Chief Executive Officer Karl Zubitz, Chief Financial Officer and Karen Massey, Chief Operating Officer. I'll now turn the call over to Tim.

Thank you, Beth, and welcome, everyone. I'll begin on Slide number three. 2024 was a phenomenal year for REGENX, We expanded our reach to over 10,000 patients globally.

Across three approved indications, and delivered significant impact to the CIDP community early into launch. We also achieved several key clinical milestones and Basivrovar joined the ranks of abbarktigimab as a Phase III asset [indiscernible] and we successfully advanced at gartigimod into larger registrational studies following GO decisions in children's disease and three subsets of myositis.

Lastly, we continue to drive innovation identifying additional level targets and nominating four pipeline molecules. These accomplishments have laid a robust foundation for our continued momentum into 2025. As we execute across the priorities highlighted on this slide, [indiscernible] we remain committed to maximizing the growth opportunities ahead of us in a data driven way always prioritizing transformational impacts [indiscernible] Slide number four, Let's begin with the commercial opportunity. ZipGarc has meaningfully shaped the GMG Treatment Landscape By Setting These Standards For Rapid Deep And Sustained Efficacy With Favorable Safety And Without Trade Offs On Convenience. We Look Forward To Continuing The Growth Momentum With Multiple Regulatory Milestones And Continued Data Generation, Supporting Earlier Use Across The Treatment Paradigm. The PCSEL Syringe Which Opens The Door For Self Administration In The U. S. Is expected to be a key driver of this growth in 2025 for both MG and CIDP. It is incredible to see the strong early adoption of Vidyard at in thirty three patients. Underpinning the real unmet need that still exists, in bringing the first major innovation in treatment to CLDT patients in over thirty years, we not only had a significant opportunity before us, to set a new treatment standard, but also an important responsibility with the long term commitment we made to the CIDP community, We will work to continue delivering transformative impact with Zscars by executing on our launch strategies while generating new evidence to support physician treatment decisions and advance our understanding of the underlying biology of this complex disease This commitment informed our decision to run the IVIG switch study soon after launch to help inform treatment decisions.

Especially with the recognition that over eighty percent of patients have IVIG experience It was also the impetus to advance our first in class C2 inhibitors into a registrational study in CIDP. We are confident that we have a unique opportunity to drive meaningful impact across two molecules, Slide five, Our disciplined approach to scaling will be critical to navigating the full opportunity across our pipeline This year, we look forward to advancing 10 Phase three studies and 10 proof of concept studies [indiscernible] and argenx hundred and nineteen. We are leading a new field of medicine in FCRN pushing the boundaries of its potential with the broadest development plan our registrational studies in My Xylus [indiscernible] shareholders and IPP are built on established proof of concepts with additional proof of concept studies in systemic sclerosis AMR, and lupus nephritis running in parallel Each of these is grounded in solid biology with the potential to drive meaningful impact in high unmet need areas. Our first in class C2 inhibitors and pass it remarks is following the same innovation playbook as at Evgotigimod The Phase two adult data in MMM were impressive with ninety four percent of patients reporting improvements compared to IVIG, we see an opportunity to disrupt a blockbuster market bringing transformative benefits to patients with MMM and now CIDP as well which is why we argenx exploring both indications in registrational head to head studies versus IVIG, And this is just scratching the surface.

Of the broad potential opportunity ahead for EMPHAS to bring a safe treatment option forward in diseases with the lectin, and classical pathways Lastly, we look forward to the first proof of concept data from our third molecule 19 argenx, in CMS. By co creating with the world experts in Musk, biology. We have built a molecule that has the potential to alleviate diseases powered by impaired neuromuscular synaptic function. The CNS data in the second half of the year is the first opportunity to assess whether argenx-one hundred and nineteen is doing what it is supposed to do clinically, which will further help us assess the opportunity ahead in SMA and ALS. Slide six we had a robust year of activity in our IIP nominating four new molecules that we are now advancing into Phase one development. These molecules including a second FcRn inhibitor argenx-two thirteen, is sweeping IgA antibody and an anti IL-six all have significant therapeutic potential across new autoimmune indications. Our IRT is an incredible product innovation engine and we have nearly 20 active programs in the discovery stages, across many relevant disease areas, that will continue to feed our future pipeline. 2025 will be our first year as a profitable company.

Which is an important achievement and a reflection of our commercial success our relentless execution and our commitment to scale innovation in a disciplined way. We have a long term growth vision that is directly influenced by our ability to continue to innovate to stay ahead of competition and to leverage our financial strength by investing in mobile targets and pipeline programs that will be the most impactful to patients. This is the future we are building with Vision 02/1930 and well beyond. I will now turn the call over to Carlo to discuss our financial position in greater detail. Thank you, Tim. Slide seven. The fourth quarter and full year 2024 financial results are detailed in the press release of this morning. Product net sales are consistent with our preannouncement in January at $737,000,000 for Q4 and $2,200,000,000 for the full year. This brings total operating income in the fourth quarter to $761,000,002,300,000,000.0 for the full year. The product net sales represents 29% quarter over quarter growth and 98% growth compared with same quarter from the prior year. The product revenue breaks down by region to $649,000,000 in The U. S, dollars 27,000,000 in Japan 49,000,000 in the rest of the world and 12,000,000 in product supply to Zai Lab in China.

Gross to net in The U. S. Continues to be around 12% In 2025, we expect the dynamics will change due to self administration resulting in an increase in gross to net which will be offset by increased patient numbers. Next slide. Cost of sales of $73,000,000 in Q4 and $227,000,000 for the full year, representing a gross margin of 90%. This is consistent with prior quarters because supply chain efficiencies are offset by growth from the card by Trullo which has a higher cost due to Halozyme royalties. The combined R and D and SG and A expenses totals $2,000,000,000 for the full year. This is aligned with our financial guidance for 2024. Total operating expenses in Q4 of $658,000,000 an increase of $83,000,000 compared to Q3 twenty twenty four. The increase is primarily due to a $61,000,000 increase in R and D reflecting our capital allocation strategy of investing in innovation. This results in an operating profit for Q4 of $103,000,000 and operating loss over full year of $22,000,000 The quarterly financial income is $39,000,000 and in the quarter we incurred exchange losses of $55,000,000 mainly related to unrealized on our non U. S. Denominated cash balances. Income tax is a benefit of $688,000,000 in Q4 and a benefit of $748,000,000 for the full year.

This is due to the recognition of a deferred tax benefit of $8.00 $2,000,000 for the full year ended December 31, 2024, of which $725,000,000 relates to a one time non recurring recognition of previously unrecognized deferred tax assets existing as of December 31, 2023. We made the decision to recognize the deferred tax as because of our assessment, but it's probable, but future taxable profits will be available. This results in profit in Q4 of $774,000,000 and profit for the full year of $833,000,000 Our cash balance represented by cash cash equivalents and current financial assets is $3,400,000,000 at year end. The balance increased by $200,000,000 in 2024 Our OpEx guidance for 2025 is approximately $2,500,000,000 of combined R and D and SG and A expenses This is a 25% increase year over year and reflects our commitment to invest in our R and D engine and pipeline growth. Zooming out we are well positioned to prioritize innovation that will support our sustainable future with our strong balance sheet and transition to profitability in 2025. I will now turn the call over to Karen who will provide details on the commercial front. Thank you, Carl. Slide nine.

I want to start by building on what both Tim and Carl have shared. Which is the importance of innovation to argenx. It's the driving force behind everything we do and we all agree that innovation only matters if it reaches patients and provides meaningful benefit. In looking back at the fourth quarter and of all of last year, I'm pleased with the continued momentum we saw from the team in bringing meaningful innovation to patients.

Our growth was fueled by both MG and CIDP. And it's encouraging to see how Vivgot continues to transform outcomes as we broaden and deepen our reach in the MG community. And it's just two quarters into the CIDP launch, we're already raising the bar on what patients can demand from their treatment. On today's call, I'll take a deeper dive into our performance highlighting the drivers that will support our continued growth in patient impact. Next slide. We continue to deliver growth in the MG in the fourth quarter.

Driven by consistent patient adds and new prescribers. They've got high Truvada played a key role reaching patients early during the treatment paradigm and predominantly in patients brand new to VIVGUT rather than switches from IV.

Some additional growth was supported by a halo effect where we saw neurologists whose first read scripts in CADP now also prescribing in MG. To maintain our leadership as the number one prescribed branded biologic in MG, we are prioritizing the anticipated launch of the pre filled syringe and continuing to invest in generating new evidence including true label extension studies. We have a long term strategy to enable continued adoption of ZivGut in earlier treatment lines and this remains our key focus.

VIVCAF's consistently strong safety and FXT profile support this goal. Particularly as physicians gain more experience with the treatment. And we'll further build this confidence by investing in evidence generation. Real world data efforts are underway to evaluate reduction in steroid use safety in new patient populations, and dosing through our DEPT next study. Which we plan to share at upcoming medical conferences. Innovation on RUV's administration will also support our shift earlier in the treatment paradigm. And the prefilled syringe is a key step towards expanding our patient reach. The opportunity to self inject at home is a significant innovation for patients and provides an added level of freedom in their treatment regime. We were thrilled to receive our first global approval of VivGut prefilled syringe this month in The EU for gMG patients and we're now looking ahead to the FDA PDUFA date In April, for both MG and CIDP.

Lastly, we see additional opportunity to address the need in the MG community by expanding our label into CR negative and ocular MG. Adapt Seron is the first of our Phase three studies to read out this year. And we have ample real world and clinical data sets supporting our ability to drive responses in this population. Ocular MG presents another exciting opportunity. And with eighty percent of patients progressing to generalized MG, we have the potential to introduce innovation, earlier in the treatment paradigm. Next slide. We're very encouraged by the continued momentum of the VIVGA HYTRULO launch in CADP. It's abundantly clear that our data are resonating across patients and physicians. With the initial demand highlighting the unmet need for safe and effective treatment alternatives. One patient shared that she had tried nearly all available CIDP treatments. And they all failed. So she was left with a heavy treatment burden of plasmapheresis every seven to fourteen days. Her physician was dedicated to improving this burden and suggested a switch to VIVGAL HYTURULO. She was initially very hesitant but after seeing the improvements, she realized she had massively underestimated the disease burden she had still been facing. Even as functional as she was, it wasn't until Vivgar Hyattrulow that she felt the enormous boulder lifted off her back.

While this patient's improvement was dramatic, this is just one of the many inspiring stories from patients and their caregivers who are empowered to demand more from their treatment. I'm incredibly proud of the team for building a solid foundation get us up to this strong start to ultimately reach our target addressable population of 12,000 patients.

Our market access team has done a phenomenal job securing broad access to support patients getting on treatment quickly. The sales force expansion further enabled us to successfully reach new prescribers deeper in the community setting.

And it paid off, twenty five percent of prescribers over the last quarter were first time Vidyard users.

As of year end, we had approximately a thousand patients on treatment, with the majority of these falling within our initial addressable population. Those who are not sufficiently controlled or who experience side effects on IVIG or steroids. Most urologists will treat patients for twelve weeks to assess this response to VIVJAT we look forward to gaining more insight on response rates and utilization in the coming quarters. We're just at the beginning. Our priority this year will be to reach more patients and more prescribers.

And repeat the MD playbook to consistently generate data to build physician support of HYTRULO while also empowering patients to ask for more from their CIDP treatment. Next slide. We also look forward to additional expansion opportunities outside The U. S. This year particularly as we plan to launch the prefilled syringe and CIDP in multiple regions. In MG, have launched in most of the major markets ex U. S. And expect consistent steady growth over time as market access dynamics fall into place. We're now reimbursed in 13 countries in Europe, including four out of the five major markets. And we're pleased with the recent MG approval in South Korea, and one that is personally very close to my heart, [indiscernible] Earlier, highlighted the positive CHMP opinion on PFS enabling sales in the EU. And this is just the first of four regulatory decisions on approval this year. We are just at the beginning of our global CIDP launch with additional decisions on approval expected in China, Europe, and Canada.

Feedback from Japan the first approval following The U. S, has been positive across patients and physicians in the CIDP community. Next slide.

Our expansive pipeline supports our next wave of growth.

And we're committed to addressing the unique challenges and gaps in treatment for autoimmune patients across multiple indications where there is often a lack of innovation and high barriers to access. We've built a robust network of which will leverage as we advance into our next launch wave. With sero negative and ocular MG. The impressive data from the ARDA study in MMN for Impassa Pruvart have already drawn attention from our prescriber base. Where there is a lot of overlap with CIDP and MG. I shared Tim's excitement about Imparta Brubart and about MMN and our opportunity to transform the treatment paradigm. We see MMN as a nascent market ripe for innovation. Similar to the initial dynamics we saw with MG, patients continue to be discouraged with the symptom burden the lack of treatment options. So the Phase three data are in 2026, will be a big moment for us to potentially introduce the first precision treatment to this community. Looking ahead, we see an opportunity with VivGuard in Myositis to serve as a bridge from urology into rheumatology. With subtypes across both therapeutic areas. We aim to leverage our urology playbook as we expand into rheumatology. Building on the traction we've already gained in the community following our decision to advance Sjogren's into a registrational study.

All in all, this is an exciting time for argenx across our entire business as we progress towards our Vision 02/1930, Tim, Thank you, Karen. Slide 14. I want to extend my sincere appreciation to the argenx team including our Board, for that outstanding work last year and their unwavering dedication to improving the lives of patients We've deliberately set a very high bar and as we move forward, it's critical with our continued innovation in the autoimmune space maintains this best in class standards, 2025 will be a year of significant growth for us expanding our commercial reach, introducing new products entering new markets and advancing our late stage pipeline. Importantly, we never lose sight of our mission. Harnessing innovation to develop transformative medicines for the patients we serve. Thank you for your time today. I would now like to open the call your questions.

Thank you. We will now begin the question and answer session. Your first question comes from the line of Tazeen Ahmad from Bank of America. Line is open. [indiscernible] Hi, good morning. Thanks for taking my questions. Mine is going to be on the PFS upcoming PDUFA. So maybe for Karen, can you talk about how you're seeing what pent up demand there could be for PFS? Are there patients that have, not gone on to therapy knowing that their potentially could be this more convenient option And if you're looking for switches to occur with that be gradual or would that be a bolus effect that we should see upon approval? And then I have a follow-up. Thanks for the question, Tazeen and for the interest. We're really excited. For the upcoming PFS PDUFA date in April and potential approval. So here's what I would say. I don't think we're seeing pent up demand In fact, I'm quite pleased with the momentum we've seen on MG and CIDP. In terms of new patient starts. It's pretty consistent. And but what we do expect is that prefilled syringe for self injection will open up both the prescriber base and the patients that will consider VIVGOT as an option for either MG or CRDP.

So we think what it will enable us to do is maintain that consistent momentum and that consistent growth which is pretty incredible as we get 13 quarters out from launch. And I think that's what the innovation allows us to do. It's not specifically a switch strategy that we're pursuing to the second part of the rather we want to focus on expanding outreach to prescribers and to patients. Thanks for the question. I think you had a follow-up.

Yeah. Either for you or Tim, how should we be thinking about just generally pricing for PFS? Would it be similar to the current options available? Or should we expect any kind of different [indiscernible] And consistent with prior launches, we will provide more color on the price at the time of our launch. But let's provide some framework on how we think about it. We'll be bringing important innovation to patients and our primary goal is to provide broad access and optionality to patients and physicians to choose on what's best for them. And of course, we will aim to price in a responsible and sustainable way for organics. Thank you for your question.

Your next question comes from the line of Alex Thompson from Stifel. Your line is open. Hey, great. Thanks for taking my questions. Congrats on the quarter. I guess as a follow-up to that question for Carl, you've talked about sort of net price impact with the PFS. I guess, can you talk a little bit more about potential magnitude there and also the rate of some kind of an impact like that, what you would expect to see upon the launch this year? Thanks.

Thank you for the question, Alex. Yes, the dynamics for self administration and this is based on the FDA approval subject of FDA approval of self will be different. And gross to net will increase Currently, it's around twelve percent with a majority of patients currently in Medicare medical benefit Part B for Bravo. With growth in with self administration, the patients will transition to pharmacy benefit or Medicare Part D for Delta. You will then get the typical rebates for a pharmacy benefit which will be higher than what we see today, and of course we will be subject to IRA redesign where the manufacturer has get 20% of a cost post catastrophic on Medicare Part D patient. All of that will result in a higher gross to net. We of course expect that increased patient volumes will offset the increase in gross to net and over time you will also see likely but the that the BBAs will be phasing out. Thank you for your question.

Your next question comes from the line of Derek Archila from Wells Fargo. Hey, good morning and thanks for taking the questions. Just one from us. How should we think about the quarter over quarter growth cadence in MG in 2025?

Relative to what we saw in 2024 And then ultimately in 1Q, should we expect some seasonal impacts? Thanks. Yes. Thanks for the question, Derek.

This is Karen. I'm happy to take it. So what I how I think about it is what I was mentioning before. Continued momentum and continued strong uptake in line with the strategy that we have of moving [indiscernible] in the treatment paradigm and broadening the prescriber base. I would expect that those underlying dynamics will continue. Specific to your question on Q1, look Q1 seasonality is an effect that is seen across the industry, And don't forget last year we had our Q1 growth rate of 6%. So are doing seeing the benefit reverification that is an industry wide phenomenon. So take that into consideration perhaps for Q1. But overall, what we're seeing is continued momentum and our underlying dynamics are good.

Thank you.

Your next question comes from the line of Yaron Werber from line is open.

Great. Maybe a couple of questions. One for For Karl, when the VPAs expire because of Part D, how does that work? I assume access stays the same or do you need to renegotiate And then for Karen, for the first twelve weeks on CIDP, are physicians actually doing in cans and are actually looking at at actually assessing formally whether patients are improving or I imagine just keeping them on therapy and if they're really not benefiting, they'll take them off?

Yiren, thank you for your question. On the VBAs, with PFS, of course, we will have to go back and the payer agreements will have to be established. We've done that now a couple of times and we need to do it again. As it is a pharmacy benefit, our expectation is that EBAs will not be part of those contracts. And so therefore, it will phase out over time. Thank you for your question.

Thanks, Karl. And yes, on the question of so we are seeing with CIDP that it's generally doctors are giving more like a twelve week trial as you mentioned. We're not hearing about a lot of use of in cat and those types of scales. They're more used in clinical trials than in clinical practice.

So So more generally, the doctors will have a conversation with their patient. They're using more simple assessments determine how their disease is being controlled by Vivgot and then making an assessment on response.

Your next question comes from the line of Victor Flock from BNP Paribas. Your line is open.

Hi. Thanks so much for taking my question. We It's also from MindyParabazan. So my first question relates to your 2025 news flow, which is broadly seen, I guess, as lighter than what you're expecting for 2026. And I mean, it's fair to say 2026 is going to be quite strong. But in the meantime, would you say that investors are overlooking the potential for the CER negative patient trial to significantly expand [indiscernible] as well as PFS ability to further drive underlying penetration in both MG and CDP. And my follow-up on the PFS is, I'm just wondering if you could help us understand how important CEP administration has been for iTRUDA's penetration ex U. S. I know you don't report any sales breakdown and that there are structural differences between U. S. Market and ex U. S. But I'm just trying to understand how safe administration on label in U. S. Could meaningfully drive sales?

No, thanks. Thanks and great to hear from you in the call.

You're right to call out that we do have self administration already for Vemgar Hachulos out of The United States.

And I will let Karan comment on why that is important for physicians and patients On use flow, this is an incredibly busy year from execution point of view. I mean, push two clinical trials forward at this speed, I think, is is a very serious task. But in the first half of the year, I think PFS is important. [indiscernible] in a minute, And then you're going to call out the significance of hopefully a positive readout in seronegative MG patients There's a significant volume of patients out there in high unmet medical needs We have seen in Japan how important that patient population actually is and how successful Vivcard actually is in treating these patients. So that could be a very important force or driver in maintaining the momentum we were alluding to. And then I would also like to call out an important group of concept study in lupus nephritis second half of this year. So Karen, do you want to continue with the importance of self administration?

Yes, absolutely. And just to reinforce, we do have self administration on label in both the EU as well as in Japan. And what we see in those markets is that when patients and physicians have a choice between the IV option and the self administration subcutaneous option, they not all patients move to the self administration. There are some patients that choose to stay with IV. That's what makes that's what fits with their lifestyle. Perhaps they prefer not to do the self administration because of needle phobia or something like that. But a good percentage of patients do have the preference and it fits into their lifestyle. To take the self administration option. So what we see is that there's real benefit to both patients and prescribers to having multiple routes of administration. So that the patient and the neurologist can really make a decision together about what makes most sense for that patient based on their disease and their lifestyle. And so we think that that same experience will come through in The U. S. If we get approval for self injection on April 10. Thanks for the question.

Your next question comes from the line of Akash Chawari from Jefferies.

Your line is open.

Hey, this is Amy on for Kash. Thanks so much for taking your questions. Starting with the myositis trial, are you planning on making any changes to the trial design after your go or no go decision? And how are you thinking about probability of success across each of the subsets now? And then finally, wanted to get your thoughts on the nutuzumab data and how that reads across the elbibizinofritis trial? So in myzitis, we announced when we made the go no go decision to go forward in all three of the subtypes with no changes to the protocol. You're correct to call out that we had some degrees of flexibility or freedom to make these changes but based on the Phase two data, we did not see any need to make changes And you can assume that because we gave the go ahead for all three subsets, that there's an equal belief in all three subsets for success in Phase three Look, in lucasnephritis, we see a number of macarons being tested. Whatever the data which we see, I think there's ample of room for improvement. There is a significant unmet medical need There's a need for a toolbox to treat these patients.

And I don't think there's going to be one size fits all. So let's focus on our data. We have strong conviction in the biology. And we're testing that mechanism of action now in Phase two. So let the data speak. But Amy, thank you for the questions.

And due to time constraints, we ask that you Hi. Thanks for taking my question. I'll keep it to just one. So just to understand some of the underlying dynamics in Mycenia Gravis. So we know that back at at launch of Vivekoy, you said that the addressable market was about seventeen thousand patients and you think there's an additional twenty five thousand that will come from growth in the biologics market by 02/1930. So I'd just be interested back in 2021 when you initially saw that 17,000 market how do you think that biologics share has progressed now, I. E, how much through that additional $25,000 are we already?

Yes. Thanks for the question around MG. And certainly, as we lay out our strategy for MG, we think that we are very much on the beginning still of the growth curve. And you talked about the market expansion. That we're already seeing from the 17,000. Since the launches we've got So we do think there has been market expansion and the way that we see that is that when since launch, we're no longer just being used or advanced biologics are no longer just being used in the most refractory patients. Rather, the advanced biologics are being used early aligned and this guard is let's say leading the charge on that.

As the number one prescribed biologics. We shared the statistic that sixty percent of are actually coming directly to VIVGOT from oral.

So that demonstrates that we're starting to penetrate that 25,000 But we believe that there's quite a long way to go and that we can maintain that consistent and steady growth Certainly, pre filter intra self injection will help us with that.

Thanks for the question.

Your next question comes from the line of Suzanne Van Verhuzen from Kempen. Your line is open.

Hi, team. This is Suzanne Penpen. Thanks for taking my question. I was wondering if you can elaborate a bit on your longer term thinking of FCR and franchise. I guess you're getting to the point where investing in more Phase three trials for Fifth Card may not always make sense and you perhaps look towards the next generation FGRN-two 13, So on two thirteen clinical developments, do you see possibilities for shorter development timelines? What are elements that you can leverage from having developed this card?

Susan, I think you're right in calling out that F7 is going to be a franchise.

It's an incredible opportunity. I think the size of the opportunity exceeds the ability to serve that with one molecule given the patent life and the IRA life of of a molecule like this card, So I think developing a molecule like Arginic 2,113 gives us optionality. And we said this is the first of successful molecules It basically unfolds optionality. I mean, either you will go and try to roll up existing indications and then you're spot on. I mean, there's so much we know about MG. There's so much we know about CLDP, ITP and the other indications to come. That actually you could leave us that know how and leapfrog with molecules like two thirteen or you basically decide you're going to open up new opportunity where you have, for example, a whole new game plan from a positioning and pricing point of view. So that optionality is in front of us and we will basically unpack it whilst the go based [indiscernible] We are really focused now on generating the Phase one data second half of this year which will tell us a lot about the potential of this molecule going forward. Thanks for the question.

Your next question comes from the line from Vikram Perhit from Morgan Stanley. Your line is open.

Hi, good morning. You for taking our question. We'll keep our question focused on the auto injector. I believe your release mentioned that you'll be looking to move this forward in 2027. So we just wanted to see what the next update could be for the auto injector and how you're thinking about how this form of Vivgard potentially could expand the opportunity beyond The IV, the subcu and the PFS. Thanks. Yes.

Thank you. I think the significance of the auto injectors or the differentiation of the auto injector from a prefilled syringe is actually having a device where the needle is invisible and does not need to be manipulated by the patient. So basic now the only job left is to hold the device against your belly you press the button, and then the device is manipulating the needle in a way that you don't see it. And that is significant for a subset of patients. So in an attempt to continue to innovate in our core markets, this is a logical next step building from the prefilled syringe From the moment for this moment, actually, we've completely focused in our communication on the pretreated syringe. It is a very innovative product. Thanks to the technologies we leverage in the formulation, and the technologies we leverage for the container. So significant innovation and I think a significant driver for the business Stay tuned on the auto injector. We're working very hard on that in the background. But it's too early to commit to a next specific update, okay? So 2027 is Yes. We are all aiming for and I will see you stay tuned.

Thank you. Your next question comes from the line of Andy Chen from Wolfe Research.

Your line is open.

This is Emma on for Andy. Thanks for taking our question.

A question on CIDP and maybe just some metrics you're seeing early on in its launch.

It was mentioned majority of patients are IVIG experienced.

Is IVIG succeeded in early lines? Are there signs of early standard of care transformation, maybe docs preferring VivGARD over IVIG, just any insight would Thanks for the question about CIDP launch. As I shared, I'm really pleased with where we're at with the launch. We're clearly seeing early success and there is a clear unmet need that you can see what we consistently hear, the feedback from the community, whether it be neurologists, patients, caregivers, [indiscernible] there is a higher treatment burden and a higher disease burden than they had realized.

So bringing the first innovation in thirty years is making a big difference. And I do think to your question, over time, we will we will transform this market and reshape what is standard of care. Right now, we're very early in the launch. We're two quarters in. I think we're doing very well.

Eighty five percent of our patients are switched from IVIG. That's exactly where we thought we would be. So we're pleased with the momentum so far.

Your next question comes from the line of Yatin Suneya from Guggenheim. Your line is open.

This is Selma for Yatin. Thanks for taking our question. So for the seronegative endocul LNG trials, what the dosing regimen in those studies? And based on your labor use of VEGARD in this population, would you anticipate that these patients will need a similar number of annual cycles as zero positive GMG or will they need more frequent dosing? And finally, how should we think about pricing in these indications?

Yes. I think the answer to this question, thank you for the question, is very simple. We don't design and we don't anticipate any different dosing in seronegative or upper end d patients as compared to the generalized MG patients, which are Acetyl Polycyvide Antibody Positive, Which We Have Currently On Label In The States. And we also don't anticipate any real pricing difference I. D. That this is label expanding and is just broadening the offering to the MG community. So can assume for the models exactly the same parameters. Thank you for the question.

Your next question comes from the line of Samantha Cemenco from Citi. Line is open. Apologize, we lost the connection. Your next question comes from the line of Matt Phipps from William Blair. Your line is open.

Hi. Thanks for taking my question. I wanted to follow-up on the myositis transition to Phase three. And just wondering if you're enrolling select a set number of patients for each of the three subsets so as to power each subset individually or will the primary endpoint be looked across all patients? Thank you. Yes, Matt, I think you're spot on. You're going to want to see a minimum representation of every subset in that Phase three registration trial in order to draw database conclusions. You can then also discuss with the FDA. So I think your underlying assumption is correct. Thank you. Your next question comes from the line of Gavin Clark Gartner from Evercore ISI.

Line is open.

Hey, guys.

For the prefilled syringe and the VBAs with the managed care organizations phasing out, I just wanted to clarify In CIDP specifically, are you planning to not have the same cap on use in those contracts?

So I think Gavin, it's Galia. I think We saw price negotiations which still needs to take place for the PFS But our expectation is that for pharmacy benefit, that you would give incremental discounts because that's what you're you typically do, but incremental base rebates and that the VBAs would not be asked for by the payers. So therefore, it will phase out. So therefore, most yes, there won't be caps.

Thank you for your question. Your next question comes from the line of Samantha Cemenco from Citi.

Your line is open.

Hi, good morning. Are you able to hear me?

Yes, we can hear you.

Perfect. Thanks very much for taking the question. I'm wondering, can you speak to your confidence in FDA granting this administration for the PFS perhaps you can just remind us on FDA's concerns surrounding self how that's factored into your strategy as you look to secure self administration for the PSS? Thank you. [indiscernible] we feel we submitted a very strong data set to the FDA with regards to the pre filled syringe, including I think a very solid human factor study which is taking into account the typical questions a regulator may have on how patients can reliably and robustly manipulate the device. So we feel we're starting from a very strong data set. I think the review is on track based from We sit We think we're on track for the PDUFA date of April 10.

And I think the type of questions which we're getting from the FDA signal that actually we're making good progress with the review of the file and that actually we are where we should be in light of the total review timeline. So we are confident based on the data sets and the currently ongoing process Ultimately, of course, this is the final call to be made by the FDA. And we try to collaborate as much as we can. Thank you for the question. Your next question comes from the line of Thomas Smith from Leerink Partners.

Line is open.

Hey guys, good morning. Thanks for taking our questions. Tim, you called out LN an important proof of concept readout in the second half of this year. I know that's a study. It's being conducted by your partner Zai in China and they just recently completed enrollment. I was just wondering if you have a sense of sort of the baseline characteristics and disease severity of these patients and how they compare to other contemporary Western LN studies?

And maybe you could just remind us how you're thinking about the bar for success with this readout? [indiscernible] Thomas, thank you for the question. First thing I want to do is applaud Zai as a reliable and high quality development partner They're not only involved in these Phase two proof of concept studies, but are also involved in a lot of the Phase three global registration trials with speed and high quality. So a very strong partnership And specifically to Ellen, the patient population which we are recruiting in China is of course perfectly in line with protocol and the inclusion exclusion criteria which is representative I think, for that patient population with significant unmet medical need, There are some variations in the type of treatments these patients undergo. But for us, this Phase two and it's a true Phase two is a proof of concept. So the first question we need to answer in this Phase two trial is, are we spot on with this mechanism of action? When we dramatically reduce pathogenic IgGs? We have the right to move the needle in this type of patients? That's the question we're going to answer. And once we have a positive answer to this question, we will flip it into a global Phase III registration trial where we will take into account some of the global treatment regimens which are typically being used.

So we take it step by step. And for the proof of concept question, I think Sai is perfectly equipped. To help us with that question. So very much looking forward to The data. Thank you.

Your next question comes from the line of Leeland Gersh from Oppenheimer. Your line is open.

Hey, good morning. Thanks for taking our questions. Just question on 119, as we look forward to the proof of concept data in CMS later this year, just wondering if you could touch on what you are looking to see and could this data impact the ongoing development of 119 and its other indications? Thank you.

Now I'd like the question about one hundred and Thank you for that. As an indication, Congenital Myasthenic Syndrome is really in the bull's eye of the biology of this target. Remember, we have been publishing and presenting spectacular data in the DOC7 animal model. Which is perfectly mimicking the TOP seven mutation in human beings. That's exactly where we're testing the CMS. Think of a genetic form of MGA which has overlap with autoimmune MG. It's fatiguable. It's typically lymph girdle, which is being affected, but also the eyes. So we are basically looking for a strong signal that we move the needle in these patients. So think it is a very important program from a proven biology point of view. But remember, we're running in parallel also a proof of concept study in ALS. And we are bringing live now a study in SMA. I would say that all these three indications are very close to the mechanism of action of the molecule but CMS I think is really close. So that is the significance of this first indication for REGENX-one hundred and nineteen. Very much looking forward to the data by the way. Thank you for the question.

Your next question comes from the line of Jun Li from Truist Securities. Your line is open.

Hi, good morning. Congrats on the quarter. This is Medi Goodarzio on for June.

A question related to your early pipeline asset. We appreciate more color on your plans for Arginnx 109 anti IS6 based on the importance of the argenx, but also given its interesting history of about fifteen years and its 200 patients Phase II in RA in Brazil. And also it's finally getting back to you. We appreciate the color there.

I think you're calling out strength of the molecule. I think this is a best in class IL-six blocker, a bit [indiscernible] A sixty to eighty days half life and already proven safety profile in two Phase 1s, one in Brazil and one in China. Happy to finally get this molecule back and there's a whole new angle which we could take in the meantime on the biology of IL-six and how it is involved in some real interesting autoimmune diseases.

So we decided not to talk too much about these indications yet. But I think we have a unique and novel angle to the biology and we're progressing the molecule this year at high speed to Phase one.

We're expecting the Phase one data second half of of this year. So stay tuned, more to be told on 109 soon.

Thank you. Your next question comes from the line of Joel Beatty from Baird.

Line is open. Good morning. Thanks for taking our question. This is Chris on for Joel.

Just a quick one on PFS. If they're approved, in April, when what are your expectations for when they can reach patients?

Yes. Thanks for the question. So we're very excited obviously for the PFS for self injection potential approval in April, as you said. We'll be ready to launch as soon as after the PDUFA date in the same way that we have for prior launches. So we expect that to be within days that we'll be out there. PFS for self injection.

Your next question comes from the line of Doug O'Sel from H. C. Wainwright. Your line is open.

Hi, good morning. Thanks for taking the questions. Maybe Karen, I think it would be helpful to hear you talk a little bit about how you think potential approval on Ocular MG might affect sort of the treatment paradigm for MG whether you sort of might see that push earlier, obviously, some of the patients present with ocular symptoms first, but sort of really whether clinicians might view it as sort of disease modifying therapy?

At that stage?

Yes. Thank you for the question. And I like how you frame it up as disease modifying. We'll have to let the data speak. But the way that I think about it very much aligned with how you're thinking about it. Our strategy is that we believe that treatment with VIVCA in early lines results in better outcomes for patients. And that's why we also wanted to move all the way into the MGFA classification one with ocular MG and we would be the first and only that would have that indication. We know that eighty percent of patients with ocular MG generalize. And as you say, potentially over time, not with this first data readout, but maybe over we can imagine that you could see data in the real world where we're able to delay that generalization And I think that's really exciting. For MG patients. And certainly that's our vision for how we would transform the market. Let's see how the data plays out, but we're relatively confident and have really strong conviction in the strategy. Thanks for the question.

Your next question comes from the line of Menos Massarakis from Deutsche Bank. Line is open. Hi. Thank you for taking my question. My name is Mr. Erik from Deutsche Bank.

So how do you think about the potential for competitors to further improve upon clinical outcomes in CIDP above EfKATIGI MOUSSO outcomes.

Do you believe complement inhibitors have a role to play in this space?

Thank you.

Yes. Thank you for the question. I I think in CRDP, we have written history because we have shown for the first time that this is an IgG driven disease in the majority of patients. And I think we have shown a response rate which is the highest ever reported in this type of clinical trial. So with a seventy percent response rate, a safety profile, which is very much in line with the non safety profile, which we all recognize is pretty unique. In this world. And then of course, we're advancing fast with the dosing optionality which we have been unpacking in this call. So we've put the bar very high We need to see data, of course, from competing molecules in the class. Where they take it. But we have certainly not seen that in myasthenia.

We were also first to market.

Is that a role for complements? I think that is. That's also why we're advancing and passing rebates in CIDP. Despite the fact that we printed the highest response rate ever with seventy percent there is a thirty percent of patients which have medical needs and were not served in the ACHEVE trial And we do know there are some clues from a biology point of view, for example, some patients having these pathogenic IgM auto antibodies which do include a complement and which do not recycle through FCRM. So I think we're unraveling the answer to your question. [indiscernible] And we're very keen to start a study and look at complement data. So there's a lot to be unpacked and a lot to be developed in CRDP.

Thank you.

We have reached the end of our question and answer session. This concludes today's conference call. Thank you for your participation.