NASDAQ:ARGX argenx Q4 2024 Earnings Report $0.70 -0.04 (-5.27%) Closing price 04:00 PM EasternExtended Trading$0.69 -0.01 (-1.02%) As of 07:50 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast GameSquare EPS ResultsActual EPS$1.58Consensus EPS $0.98Beat/MissBeat by +$0.60One Year Ago EPSN/AGameSquare Revenue ResultsActual Revenue$761.22 millionExpected Revenue$678.52 millionBeat/MissBeat by +$82.71 millionYoY Revenue GrowthN/AGameSquare Announcement DetailsQuarterQ4 2024Date2/27/2025TimeBefore Market OpensConference Call DateThursday, February 27, 2025Conference Call Time8:30AM ETConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckInterim ReportAnnual ReportEarnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by argenx Q4 2024 Earnings Call TranscriptProvided by QuartrFebruary 27, 2025 ShareLink copied to clipboard.PresentationSkip to Participants Operator00:00:00Good morning. My name is Rob, 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 speakers' remarks, there will be a question and answer session. Operator00:00:13Thank you. I'd now like to introduce Beth DelJacco, Vice President, Corporate Communications and Investor Relations. You may begin your conference. Beth DelGiaccoVP and Global Head of Corporate Communications & Investor Relations at argenx SE00:00:23Thank you. A press release was issued earlier today with our fourth quarter and a full year '20 '20 '4 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 developments, regulatory timelines, the potential success of our product candidates, financial projections and upcoming milestones. Beth DelGiaccoVP and Global Head of Corporate Communications & Investor Relations at argenx SE00:00:53Actual results may differ materially from those indicated by these statements. Argenesis 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 Tim Van Haramuren, Chief Executive Officer Carl Zubits, Chief Financial Officer and Karen Massey, Chief Operating Officer. I will now turn the call over to Tim. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:01:17Thank you, Beth, and welcome, everyone. I'll begin on Slide number three. 20 20 four was a phenomenal year for argenx. We expanded our reach to over 10,000 patients globally across three approved indications and delivered significant impact to the CIGP community early into launch. We also achieved several key clinical milestones and Parsiprobar joined the ranks of efgartigimab as a Phase three asset following impressive NMN data and we successfully advanced efgartigimab into larger registration studies following core decisions in Sjogren's disease and three subsets of myositis. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:02:01Lastly, we continue to drive innovation, identifying additional novel 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 towards CyberVision 02/1930, we remain committed to maximizing the growth opportunities ahead of us in a data driven way, always prioritizing transformational impacts for patients. Slide number four, let's begin with the commercial opportunity. Flipkart 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:02:53We look forward to continuing the growth momentum with multiple regulatory milestones and continued data generation supporting earlier use across the treatment paradigm. The pre filled syringe, which opens the door for self administration in The US, 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 the card atulog in CIDP patients, underpinning the real unmet need that still exists in bringing the first major innovation in treatment to CIDP 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 VipGard 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 recognition that over eighty percent of patients have IV IG experience. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:04:23It was also the impetus to advance our first in class C2 inhibitors into a registration 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 across efgartigimod and pass it through BARC and argenx one hundred and nineteen. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:05:02We are leading a new field of medicine in FCRM pushing the boundaries of its potential with the broadest development plan. Our registrational studies in MISIDIS, TED, Sjogren's and ITP 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 impacts in high unmet need areas. Our first in class C2 inhibitors, m paciprobar, is following the same innovation playbook as of efgartigimod. The Phase II ARDA data in MNN were impressive with ninety four percent of patients reporting improvements on AMPA compared to IVIG. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:05:57We see an opportunity to disrupt a blockbuster market bringing transformative benefits to patients with MMN and now CIDP as well, which is why we are 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 EMPA to bring a safe treatment option forward in diseases for the lectin and classical pathways are at play. Lastly, we look forward to the first proof of concept data from our third molecule, argenx 119 in CMS. By cocreating with the world experts in musk biology, we have built a molecule that has the potential to alleviate diseases hallmark 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:07:06Slide six. We had a robust field 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, a sweeping IgA antibody and an anti IL6 all have significant therapeutic potential across new autoimmune indications. Our IRT is an incredible productive 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:08:04We 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. Karl GubitzChief Financial Officer at argenx SE00:08:34Thank you, Tim. Slide seven. Karl GubitzChief Financial Officer at argenx SE00:08:36The fourth quarter and the full year 2024 financial results are detailed in the press release of this morning. Product net sales are consistent with our pre announcement in January at seven thirty seven million dollars for Q4 and $2,200,000,000 for the full year. This brings total operating income in the fourth quarter to $761,000,000 and $2,300,000,000 for the full year. The product net sales represents 29% quarter over quarter growth and 98% growth compared with the same quarter from the prior year. The product revenue breaks down by region to $649,000,000 in The U. Karl GubitzChief Financial Officer at argenx SE00:09:22S, Twenty Seven Million Dollars in Japan, Forty Nine Million Dollars 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. Karl GubitzChief Financial Officer at argenx SE00:09:50Next slide. Cost of sales were $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 Vibcar Tytrulio, 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. Karl GubitzChief Financial Officer at argenx SE00:10:29Total operating expenses in Q4 are $658,000,000 an increase of $83,000,000 compared with 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 an operating loss for the 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 FX on our non U. S. Denominated cash balances. Karl GubitzChief Financial Officer at argenx SE00:11:23Income 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 12/31/2024, of which $725,000,000 dollars relates to a one time non recurring recognition of previously unrecognized deferred tax assets existing as of 12/31/2023. We made the decision to recognize the deferred tax asset because of our assessment that is probable that 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. Karl GubitzChief Financial Officer at argenx SE00:12:39Our 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. Karen MasseyChief Operating Officer at argenx SE00:13:19Thank 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. Karen MasseyChief Operating Officer at argenx SE00:13:48Our growth was fueled by both MG and CIDP and it's encouraging to see how VIVVAC continues to transform outcomes as we broaden and deepen our reach in the MG community. And at 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. Karen MasseyChief Operating Officer at argenx SE00:14:26VIVGAR HYTURO played a key role in reaching patients earlier in the treatment paradigm and predominantly in patients brand new to VIVGAR rather than switches from IV. Some additional growth was supported by a halo effect from the CIDP launch where we saw neurologists whose first read scripts in CIDP 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 through label extension studies. We have a long term strategy to enable continued adoption of this gut in earlier treatment lines and this remains our key And we'll further build this confidence by investing in evidence generation. And we'll further build this confidence by investing in evidence generation. Karen MasseyChief Operating Officer at argenx SE00:15:25Real world data efforts are underway to evaluate reduction in steroid use, safety in new patient populations and dosing through our ADAPT next study, which we plan to share at upcoming medical conferences. Innovation on RUTU'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 pre filled 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. Karen MasseyChief Operating Officer at argenx SE00:16:13Lastly, we see additional opportunity to address the unmet need in the MG community by expanding our label into seronegative and ocular MG. ADAPTseron is the first of our Phase three studies to read out this year. And we have ample real world and clinical datasets 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. Karen MasseyChief Operating Officer at argenx SE00:16:46Next slide. We're very encouraged by the continued momentum of the VIVGARD HYTULO launch in CIDP. 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. Karen MasseyChief Operating Officer at argenx SE00:17:18Her physician was dedicated to improving this burden and suggested a switch to VIVGAR HYTULO. 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 HYTULO 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 were empowered to demand more from their treatment. I'm incredibly proud of the team for building a solid foundation to get us off to this strong start to ultimately reach our target addressable population of 12,000 patients. Karen MasseyChief Operating Officer at argenx SE00:18:01Our 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 users. As of year end, we had approximately 1,000 patients on treatment with the majority of these falling within our initial addressable population. Those who are not sufficiently controlled for all who experience side effects on IVIG or steroids. Karen MasseyChief Operating Officer at argenx SE00:18:36Most urologists will treat patients for twelve weeks to assess this response to VIBGAR. So 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 MG playbook to consistently generate data to build physician support of Hytulo while also empowering patients to ask for more from their CIDP treatment. Next slide. Karen MasseyChief Operating Officer at argenx SE00:19:06We 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, we have launched in most of the major markets ex U. S. Karen MasseyChief Operating Officer at argenx SE00:19:21And 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 approvals in South Korea and one that is personally very close to my heart, Australia. Earlier, I 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. Karen MasseyChief Operating Officer at argenx SE00:20:01Feedback 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. Karen MasseyChief Operating Officer at argenx SE00:20:16And 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 relationships in the neurology community with over 3,500 VIVGAR prescribers, which we'll leverage as we advance into our next launch wave with seronegative and ocular MG. The impressive data from the ARDA study in MMN for IMPASA PROVART 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 IMPAZ approved at 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. Karen MasseyChief Operating Officer at argenx SE00:21:07Patients continue to be discouraged with the symptom burden and the lack of treatment options. So the Phase three data 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 neurology into rheumatology with subtypes across both therapeutic areas. We aim to leverage our neurology 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. Karen MasseyChief Operating Officer at argenx SE00:21:51Tim? Tim Van HauwermeirenCEO & Executive Director at argenx SE00:21:53Thank you, Karen. Slide 14. I want to extend my sincere appreciation to the argenx team, including our board for their 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 that our continued innovation in the autoimmune space maintains its 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:22:36Importantly, 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 to your questions. Operator00:22:52Thank you. We will now begin the question and answer session. Your first question comes from the line of Tazeen Ahmad from Bank of America. Your line is open. Tazeen AhmadMD - US Equity Research at Bank of America00:23:14Hi, good morning. Thanks for taking my questions. Mine are 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 there potentially could be this more convenient option? Tazeen AhmadMD - US Equity Research at Bank of America00:23:36And if you're looking for switches to occur, would that be, gradual or would that be a bolus effect that we should see upon approval? And then I have a follow-up. Karen MasseyChief Operating Officer at argenx SE00:23:50Yes. Thanks for the question, to the end of the interest. We're really excited, for the upcoming CFS, PDUFA date in April, and potential approval. So here's what I would say. I don't think we're seeing pent up demand. Karen MasseyChief Operating Officer at argenx SE00:24:03In 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, and, but what we do expect is that free filter range for self injection will open up, both the prescriber base and the patient, that will consider VivGut as an option for either MG or CIDP. 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. Karen MasseyChief Operating Officer at argenx SE00:24:39It's not specifically a switch strategy that we're pursuing, to the second part of the question that you asked. Rather, we want to focus on expanding, outreach to prescribers and to patients. Thanks for the question. I think you had a follow-up. Tazeen AhmadMD - US Equity Research at Bank of America00:24:52Yes. 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 difference? Karl GubitzChief Financial Officer at argenx SE00:25:06Hi, Tazir. It's Carl here. Thank you for your questions. Consistent with prior launches, we will provide more color on the price at the time of the launch. But let's provide some framework on how we think about it. Karl GubitzChief Financial Officer at argenx SE00:25:19We'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 Organixx. Thank you for your question. Operator00:25:40Your next question comes from the line of Alex Thompson from Stifel. Your line is open. Alex ThompsonManaging Director at Stifel Institutional00:25:45Hey, great. Thanks for taking our 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? Alex ThompsonManaging Director at Stifel Institutional00:26:03What you would expect to see, upon the launch this year? Thanks. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:26:08Thank you for the question, Alex. Yes, the dynamics for self administration and FDA approval of self administration of course, 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 patients. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:27:04All 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 that the VVAs will be phasing out. Thank you for your question. Operator00:27:26Your next question comes from the line of Derek Archila from Wells Fargo. Your line is open. Derek ArchilaAnalyst at Wells Fargo00:27:32Hey, good morning and thanks for taking the questions. Just one from us. I guess 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? Derek ArchilaAnalyst at Wells Fargo00:27:50Thanks. Karen MasseyChief Operating Officer at argenx SE00:27:50Yes. Thanks for the question, Derek. This is Karen. I'm happy to take it. Karen MasseyChief Operating Officer at argenx SE00:27:54So, what I how I think about it is what I was mentioning before in MG, continued momentum and continued strong uptake in line with the strategy that we have of moving earlier lines in the treatment paradigm and broadening the prescriber base. Well 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 we are doing seeing the benefit revert verifications. Karen MasseyChief Operating Officer at argenx SE00:28:32That 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. Derek ArchilaAnalyst at Wells Fargo00:28:45Thank you. Operator00:28:47Your next question comes from the line of Yaron Werber from TD Cowen. Your line is open. Yaron WerberManaging Director, Senior Biotechnology Analyst at Cowen and Company00:28:54Great. Maybe a couple of questions. One for Carl. When the VPAs expire because of Part D, how does that work? I assume access stays the same or do you need to renegotiate? Yaron WerberManaging Director, Senior Biotechnology Analyst at Cowen and Company00:29:09And then for Karen, for the first twelve weeks on CODP, are physicians actually doing incants and are they actually looking at are they actually assessing formally whether patients are improving or I imagine they're just keeping them on therapy and if they're really not benefit they'll take them off? Thank you. Karl GubitzChief Financial Officer at argenx SE00:29:29Durin, thank you for your question. On the VBAs, with BFS, 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. And as it is a pharmacy benefit, our expectation is that BBAs will not be part of those contracts and so therefore it will phase out over time. Thank you for your question. Karen MasseyChief Operating Officer at argenx SE00:29:58Thanks, Carl. And, and yet 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 excuse me so more generally the doctors will have a conversation with their patient they're using more simple assessments to determine how their disease is being controlled by Vivint and then making an assessment on response. Operator00:30:33Your next question comes from a line of Victor Flock from BNP Paribas. Your line is open. Victor Floc'hEquity Research Analyst at BNP Paribas00:30:41Hi. Thanks so much for taking my question. Viktor Flock from Mindyparabegasan. 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 that 2026 is going to be quite strong. Victor Floc'hEquity Research Analyst at BNP Paribas00:30:59But in the meantime, would you say that investors are overlooking the potential for the SIR negative Phase II trial to significantly expand MG as a small opportunity as well as PFS ability to further drive your lines 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 the administration has been for iTrudo's penetration ex U. S? I know you don't report any sales breakdown and that there are structural differences between U. S. Victor Floc'hEquity Research Analyst at BNP Paribas00:31:33Market and ex U. S. But just trying to understand how self administration on label in U. S. Could meaningfully drive sales? Victor Floc'hEquity Research Analyst at BNP Paribas00:31:41Thanks so much. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:31:43Thanks and great to hear from you in the call. You're right to Carla that we do have self administration already for Fevigar Haktulo outside of The United States. And I will let Karan comment on, you know, why that is important for physicians and patients. On use flow, this is an incredibly busy year from an execution point of view. I mean, pushing 10 Phase three clinical trials and 10 Phase two clinical trials forward at this speed I think is a very serious task. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:32:13But in the first half of the year, I think EFS is important, which hopefully self administration as Karen will explain in a minute. And then you're correct to call out, you know, the significance of hopefully a positive readout in seronegative MG patients. There's a significant volume of patients out there in higher unmet medical needs. We have seen in Japan, you know, how important that patient population actually is and how successful Vivigart actually is in treating these patients. So that could be a very important force or driver in maintaining the momentum we were alluding to. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:32:46And then I would also like to call out an important proof of concept study in lupus nephritis second half of this year. So Karim, do you want to continue with the importance of self administration? Karen MasseyChief Operating Officer at argenx SE00:33:01Yeah, 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, to self administration. There are some patients that choose to stay with IV. That's what makes, that's what fits with their lifestyle. Karen MasseyChief Operating Officer at argenx SE00:33:31Perhaps 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 that same experience, will come through in The U. S. If we get approval for self injection on April 10. Karen MasseyChief Operating Officer at argenx SE00:34:12Thanks for the question. Operator00:34:15Your next question comes from the line of Akash Tewari from Jefferies. Your line is open. Amy LiSVP Equity Research at Jefferies00:34:22Hey, this is Amy on for Akash. 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 the probability of success across each of the subsets now? And then finally, wanted to get your thoughts on the abinutuzumab data and how that reads across Amy LiSVP Equity Research at Jefferies00:34:44to your lupus nephritis trial? Tim Van HauwermeirenCEO & Executive Director at argenx SE00:34:48So, in myositis, 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 are 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 leukosnivitis, we see a number of measurements being tested. Whatever the data which we see, I think there's ample of room for improvement. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:35:29There is a significant unmet medical need. There is a need for a toolbox to treat these patients and I don't think there is going to be one size fits all. So let's focus on our data. We have strong conviction in the biology and we are testing that mechanism of action now in Phase two. So let the data speak. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:35:47But Amy, thank you for the questions. Operator00:35:56Your next question comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Rajan SharmaExecutive Director at Goldman Sachs00:36:01Hi. Thanks for taking my question. I'll keep it to just one. So just to understand some of the underlying dynamics in myasthenia gravis. So we know that back at launch of VIVGAR, you said that the addressable market was about seventeen thousand patients and you think there's an additional 25,000 that will come from growth in the biologics market by '2 thousand and '30. Rajan SharmaExecutive Director at Goldman Sachs00:36:24So 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? Thank you. Karen MasseyChief Operating Officer at argenx SE00:36:38Yes. 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 17000, since the launch of this gut. So we do think there has been market expansion. Karen MasseyChief Operating Officer at argenx SE00:37:03And 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 earlier line. And this guide is, let's say, leading the charge on that as the number one prescribed biologic. We shared the statistic that sixty percent of patients are actually coming directly to Vivgut from orals. So that demonstrates that we're starting to penetrate, that twenty five thousand. Karen MasseyChief Operating Officer at argenx SE00:37:33But we believe that there's quite a long way to go and that we can maintain that consistent and steady growth. Certainly, pre filled syringe for self injection will help us with that. Thanks for the question. Operator00:37:46Your next question comes from a line from Susan Van Verheusen from Kempen. Your line is open. Suzanne van VoorthuizenHead of Life Sciences Equity Research at Van Lanschot Kempen00:37:53Hi, team. This is Suzanne Van Verhuizen. Thanks for taking my question. I was wondering if you can elaborate a bit on your longer term thinking of FcRn franchise. I guess you're getting to the point where investing in more Phase two trials for FIFGARD may not always make sense and you perhaps look towards the next generation FcRn two thirteen. Suzanne van VoorthuizenHead of Life Sciences Equity Research at Van Lanschot Kempen00:38:13So on two thirteen clinical developments, do you see possibilities for shorter development timelines? What are elements that you can leverage from having developed safeguards? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:38:28Yes, 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 a molecule like like DeepGard. So, I think developing a molecule like argenx two thousand one hundred and thirteen gives us optionality and we said this is the first of, you know, successor molecules. It basically unfolds optionality. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:38:59I 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 CIDP, ITP and the other indications to come that actually you could leave us that know how and and and and 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 we go based on data. We are really focused now on generating the Phase I data second half of this year, which will tell us a lot about the potential of this molecule going forward. Thanks for the question. Operator00:39:46Your next question comes from the line from Vikram Parohit from Morgan Stanley. Your line is open. Vikram PurohitAnalyst at Morgan Stanley00:39:53Hi, good morning. Thank you for taking our question. We'll keep our question focused Vikram PurohitAnalyst at Morgan Stanley00:39:57on 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 VIVGUARD potentially could expand the opportunity beyond, the IV, the Vikram PurohitAnalyst at Morgan Stanley00:40:14subcu and the PFS? Thanks. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:40:18Yes. Thank you. Vikram, the significance of the auto injector 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 basically 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:40:44So in an attempt to continue to innovate in our core market, 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 prefilled syringe. It is a very innovative product, thanks to, you know, the technologies we leverage in the formulation and the technologies we leverage for the containers. So significant innovation and I think a significant driver for the business. Stay tuned on the auto injector. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:41:13We'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 the year we're all aiming for and I would say stay tuned. Vikram PurohitAnalyst at Morgan Stanley00:41:25Thank you. Operator00:41:27Your next question comes from the line of Andy Chen from Wolfe Research. Your line is open. Emma GutsteinEquity Research Associate at Wolfe Research00:41:33Hi. 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. Emma GutsteinEquity Research Associate at Wolfe Research00:41:44Is IVIG succeeded in early lines? Are there signs of early standard care transformation, maybe docs performing VIVGART over IVIG? Just any insight would be great. Thank you. Karen MasseyChief Operating Officer at argenx SE00:41:57Yes. 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. And what we consistently hear, the feedback from the community, whether it be neurologists, patients, caregivers, is that there is a higher treatment burden and a higher disease burden than they had realized. Karen MasseyChief Operating Officer at argenx SE00:42:21So bringing the first innovation in thirty years, is making a big difference. And I do think to your question, over time, 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. Karen MasseyChief Operating Officer at argenx SE00:42:39Eighty five percent of our patients are switched from IVIG and that's exactly where we thought we would be. So we're pleased with the momentum so far. Operator00:42:52Your next question comes from the line of Yatin Sineya from Guggenheim. Your line is open. Analyst00:42:58Hi, this is Selma for Yatin. Thanks for taking our question. So for the seronegative endocular MG trials, what's the dosing regimen in those studies? And based on your off label use of VipGuard in this population, would you anticipate that these patients will need a similar number of annual cycles at zero positive GMT? Or will they need more frequent dosing? Analyst00:43:21And finally, how should we think about pricing in these indications? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:43:27I think the answer to this question, thank you for the question, is very simple. We don't design and we don't anticipate any difference dosing in seronegative or ocular MG patients as compared to the generalized MG patients which are acetylcholine receptor antibody positive, which we have currently on label in The States. And we also don't anticipate any real pricing difference. ID is that this is label expanding and is just broadening the offering to the MG community. So you can assume for the models exactly the same parameters. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:44:00Thank you for the question. Operator00:44:03Your next question comes from the line of Samantha Simenco from Citi. Your line is open. I apologize, we lost the connection. Your next question comes from the line of Matt Phipps from William Blair. Your line is open. Matt PhippsGroup Head - Biotechnology at William Blair00:44:22Hi. 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 component be looked across all patients? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:44:41Yes, Matt, I think you're spot on. You will want to see a minimum representation of every subset in that Phase three registration trial in order to draw, you know, database conclusions, you can then also discuss with the FDA. So I think your underlying assumption is correct. Thank you. Operator00:45:02Your next question comes from the line of Gavin Clark Gartner from Evercore ISI. Your line is open. Gavin Clark-GartnerDirector - Biotechnology Equity Research at Evercore ISI00:45:09Hey, 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? Karl GubitzChief Financial Officer at argenx SE00:45:27So, I think Gavin, it's Karl here. I think, we sell price negotiations which still needs to take place for the PFS, but our expectation is that for pharmacy benefit that you would keep incremental discounts because that's what 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, those, yes, there won't be gaps. Thank you for your question. Operator00:46:01Your next question comes from the line of Samantha Simenka from Citi. Your line is open. Samantha SemenkowVice President at Citi00:46:07Hi, good morning. Are you able to hear me? Tim Van HauwermeirenCEO & Executive Director at argenx SE00:46:10Yes, we can hear you. Samantha SemenkowVice President at Citi00:46:12Perfect. Thanks very much for taking the question. I'm wondering, can you speak to your confidence in FDA granting the self administration for the PFS? And perhaps you can just remind us on FDA's concerns surrounding self administration for the butterfly needle process and how that's factored into your strategy as you look to secure self administration for the PFS? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:46:34Yes. So, taking the step back, we feel we submitted a very strong data set to the FDA with regards to the pre fill syringe including I think a very solid human factor study which is taking into account the typical questions a regulator may have on, you know, 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 where 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:47:19So 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. Operator00:47:35Your next question comes from the line of Thomas Smith from Leerink Partners. Your line is open. Thomas J. SmithSenior Managing Director, Immunology and Metabolism at Leerink Partners00:47:44Hey guys, good morning. Thanks for taking our questions. Tim, you called out LN as an important proof of concept readout in the second half of this year. I know that's a study that's being conducted by your partner Xi in China and they just recently completed enrollment. I was just wondering if you have Thomas J. SmithSenior Managing Director, Immunology and Metabolism at Leerink Partners00:47:59a sense of sort of Thomas J. SmithSenior Managing Director, Immunology and Metabolism at Leerink Partners00:48:01the 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. Thanks. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:48:16Yes, Thomas, thank you for the question. First thing I want to do is applaud Zai as a reliable and high quality development partner that are not only involved in these Phase II proof of concept studies, but are also involved in a lot of the Phase III global registration trials with with SPIN and high quality. So a very strong partnership. And specifically to LN, 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, LN patient population with significant unmet medical needs. There are some variations in the type of treatments these patients undergo. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:48:57But for us, this Phase II and it's a true Phase II is a proof of concept. So the first question we need to answer in this Phase II trial is, are we spot on with this mechanism of action? And when we dramatically reduce phytogenic IgG, do you 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 three registration trial where we will take into account, you know, some of the global treatment regimens which are typically being used. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:49:28So we take it step by step. And for the proof of concept question, I think Sai is perfectly equipped to help us address that question. So we are very much looking forward to the data. Thank you. Operator00:49:42Your next question comes from the line of Leland Gershell from Oppenheimer. Your line is open. Leland GershellManaging Director - Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:49:48Hey, good morning. Thanks for taking our questions. Just a question on 01/2019. 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 one hundred and nineteen and its other indications? Leland GershellManaging Director - Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:50:07Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:50:09Now I like the question about 119. Thank you for that. As an indication, from genetal myasthenic syndrome is, you know, really in the bull's eye of the biology of this target. Remember, we have been publishing and presenting spectacular data in the DOG7 animal model which is perfectly mimicking the DOG7 mutation in in human beings and that's exactly where we're testing the CMS. Think of, you know, a genetic form of MGA which has overlap with autoimmune MG. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:50:41It's fatiguable. It's typically limb girdle which is being affected, but also the eyes. So we're basically looking for a strong signal that we move the needle in these patients. So I 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're bringing life now the study in SMA. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:51:05I would say that all these 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 argenx one hundred and nineteen. We're very much looking forward to the data, by the way. Thank you for the question. Operator00:51:23Your next question comes from the line of June Lee from Truist Securities. Your line is open. Mehdi GoudarziBiotech Equity Research Analyst at Truist Securities00:51:30Hi, good morning. Congrats on the quarter. This is Mehdi Gudarze on for June. A question related to your early pipeline assets. We appreciate more color on your plans for argenx109 and high IL-six. Mehdi GoudarziBiotech Equity Research Analyst at Truist Securities00:51:48Based on the importance of the target, 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:52:08I think you're calling out the strength of the molecule. I think this is a best in class IL-six blocker with bicomolar potency, a sixty to eighty days half life and already proven safety profile, in two Phase 1s actually, 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 through Phase one. We're expecting the Phase one data second half of this year. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:52:50So stay tuned. More to be told on 01/2009 soon. Thank you. Operator00:52:55Your next question comes from the line of Joel Beatty from Baird. Your line is open. Analyst00:53:02Good 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? Analyst00:53:14Thank you. Karen MasseyChief Operating Officer at argenx SE00:53:17Yes. 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 it to be within days that will be out there with PFS for self injection. Operator00:53:40Your next question comes from the line of Doug Laseo from H. C. Wainwright. Your line is open. Douglas TsaoManaging Director at H.C. Wainwright & Co.00:53:49Hi, 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 in ocular MG might affect sort of the treatment paradigm for MG? And whether you sort of might see that push earlier, obviously, because some of the patients present with ocular symptoms first, but sort of really you know, whether clinicians might view it as sort of disease modifying therapy at that stage? Douglas TsaoManaging Director at H.C. Wainwright & Co.00:54:21Thank you. Karen MasseyChief Operating Officer at argenx SE00:54:23Yes. Thank you for the question. And I like how you frame it up as disease modifying. Look, we'll have to let the data speak. But the way that I think about it is very much aligned with how you're thinking about it. Karen MasseyChief Operating Officer at argenx SE00:54:36Our strategy is that we believe that treatment with Vivka in earlier 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, 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 time, we can imagine that you could see data in the real world with where we're able to delay that generalization. Karen MasseyChief Operating Officer at argenx SE00:55:09And 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. Operator00:55:27Your next question comes from the line of Manos Maserakis from Deutsche Bank. Your line is open. Manos MastorakisAnalyst at Deutsche Bank00:55:34Thank you for taking my question. Manos Maserakis from Deutsche Bank. So how do you think about the potential for competitors to further improve upon clinical outcomes in CIDP above efgartigimod's outcomes? And do you believe complement inhibitors have a role to play in this space? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:55:56Yes. Thank you for the question. I think in CIDP, we have written history because we have shown for the first time that actually 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 it is seventy percent response rate, a safety profile which is very much in line with the known safety profile which we all recognize is pretty unique in this world. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:56:25And then of course we are 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 Maesthenia. We were also first to market. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:56:45Is that a role for complement? Karl GubitzChief Financial Officer at argenx SE00:56:47I think that is. That's also why we're advancing empasiprobot in CIDP despite the fact that we printed the highest response rate average at seventy percent. That is a thirty percent of patients, you know, which have medical needs and were not served in the ATHIEVE 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 complement and which do not recycle through FcRn. So I think we're unraveling the answer to your question. Karl GubitzChief Financial Officer at argenx SE00:57:21I think empaciprobar really deserves the short on goal and we're very keen to start this study and look at complement data. So there's a lot to be unpacked and a lot to be developed in CIDP. Thank you. Operator00:57:36And we have reached the end of our question and answer session. This concludes today's conference call. Thank you for your participation. You may now disconnect.Read moreParticipantsExecutivesBeth DelGiaccoVP and Global Head of Corporate Communications & Investor RelationsTim Van HauwermeirenCEO & Executive DirectorKarl GubitzChief Financial OfficerKaren MasseyChief Operating OfficerAnalystsTazeen AhmadMD - US Equity Research at Bank of AmericaAlex ThompsonManaging Director at Stifel InstitutionalDerek ArchilaAnalyst at Wells FargoYaron WerberManaging Director, Senior Biotechnology Analyst at Cowen and CompanyVictor Floc'hEquity Research Analyst at BNP ParibasAmy LiSVP Equity Research at JefferiesRajan SharmaExecutive Director at Goldman SachsSuzanne van VoorthuizenHead of Life Sciences Equity Research at Van Lanschot KempenVikram PurohitAnalyst at Morgan StanleyEmma GutsteinEquity Research Associate at Wolfe ResearchAnalystMatt PhippsGroup Head - Biotechnology at William BlairGavin Clark-GartnerDirector - Biotechnology Equity Research at Evercore ISISamantha SemenkowVice President at CitiThomas J. SmithSenior Managing Director, Immunology and Metabolism at Leerink PartnersLeland GershellManaging Director - Senior Biotechnology Analyst at Oppenheimer & Co. Inc.Mehdi GoudarziBiotech Equity Research Analyst at Truist SecuritiesDouglas TsaoManaging Director at H.C. Wainwright & Co.Manos MastorakisAnalyst at Deutsche BankPowered by Conference Call Audio Live Call not available Earnings Conference CallGameSquare Q4 202400:00 / 00:00Speed:1x1.25x1.5x2xTranscript SectionsPresentationParticipants Earnings DocumentsSlide DeckInterim reportAnnual report GameSquare Earnings HeadlinesGameSquare enters partnership with GGTech EntertainmentApril 18 at 6:16 PM | markets.businessinsider.comGameSquare Holdings, Inc. (GAME) Q4 2024 Earnings Call TranscriptApril 16, 2025 | seekingalpha.comNow I look stupid. Real stupid... I thought what happened 25 years ago was a once- in-a-lifetime event… but how wrong I was. Because here we are, a quarter of a century later, almost to the exact day, and it’s happening again. April 21, 2025 | Porter & Company (Ad)GameSquare Holdings, Inc.: GameSquare Forms Strategic Partnership with GGTech Entertainment to Bring Proven Esports and Gaming Events to U.S. MarketsApril 16, 2025 | finanznachrichten.deGameSquare Holdings, Inc.: GameSquare Holdings Reports 2024 Full Year ResultsApril 16, 2025 | finanznachrichten.deGameSquare Holdings GAAP EPS of -$0.81 misses by $0.72, revenue of $23.47M misses by $6.19MApril 15, 2025 | seekingalpha.comSee More GameSquare Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like GameSquare? Sign up for Earnings360's daily newsletter to receive timely earnings updates on GameSquare and other key companies, straight to your email. Email Address About GameSquareGameSquare (NASDAQ:GAME), Inc. operates as a vertically integrated digital media, entertainment, and technology company. Its platform to connect with gaming and youth culture audiences. The company's end-to-end platform includes Code Red Esports Ltd., an esports talent agency; GCN, a digital media company focusing on the gaming and esports audience; Zoned, a gaming and lifestyle marketing agency; Complexity Gaming, a esports organization operating; Fourth Frame Studios, a creative production studio; and Mission Supply, a merchandise and consumer products business; Frankly Media, programmatic advertising, Stream Hatchet, live streaming analytics, and Sideqik a social influencer marketing platform. The company also engages in providing marketing and creative services, offering leading data and analytics solutions. The company was formerly known as Engine Gaming & Media, Inc. 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PresentationSkip to Participants Operator00:00:00Good morning. My name is Rob, 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 speakers' remarks, there will be a question and answer session. Operator00:00:13Thank you. I'd now like to introduce Beth DelJacco, Vice President, Corporate Communications and Investor Relations. You may begin your conference. Beth DelGiaccoVP and Global Head of Corporate Communications & Investor Relations at argenx SE00:00:23Thank you. A press release was issued earlier today with our fourth quarter and a full year '20 '20 '4 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 developments, regulatory timelines, the potential success of our product candidates, financial projections and upcoming milestones. Beth DelGiaccoVP and Global Head of Corporate Communications & Investor Relations at argenx SE00:00:53Actual results may differ materially from those indicated by these statements. Argenesis 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 Tim Van Haramuren, Chief Executive Officer Carl Zubits, Chief Financial Officer and Karen Massey, Chief Operating Officer. I will now turn the call over to Tim. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:01:17Thank you, Beth, and welcome, everyone. I'll begin on Slide number three. 20 20 four was a phenomenal year for argenx. We expanded our reach to over 10,000 patients globally across three approved indications and delivered significant impact to the CIGP community early into launch. We also achieved several key clinical milestones and Parsiprobar joined the ranks of efgartigimab as a Phase three asset following impressive NMN data and we successfully advanced efgartigimab into larger registration studies following core decisions in Sjogren's disease and three subsets of myositis. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:02:01Lastly, we continue to drive innovation, identifying additional novel 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 towards CyberVision 02/1930, we remain committed to maximizing the growth opportunities ahead of us in a data driven way, always prioritizing transformational impacts for patients. Slide number four, let's begin with the commercial opportunity. Flipkart 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:02:53We look forward to continuing the growth momentum with multiple regulatory milestones and continued data generation supporting earlier use across the treatment paradigm. The pre filled syringe, which opens the door for self administration in The US, 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 the card atulog in CIDP patients, underpinning the real unmet need that still exists in bringing the first major innovation in treatment to CIDP 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 VipGard 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 recognition that over eighty percent of patients have IV IG experience. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:04:23It was also the impetus to advance our first in class C2 inhibitors into a registration 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 across efgartigimod and pass it through BARC and argenx one hundred and nineteen. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:05:02We are leading a new field of medicine in FCRM pushing the boundaries of its potential with the broadest development plan. Our registrational studies in MISIDIS, TED, Sjogren's and ITP 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 impacts in high unmet need areas. Our first in class C2 inhibitors, m paciprobar, is following the same innovation playbook as of efgartigimod. The Phase II ARDA data in MNN were impressive with ninety four percent of patients reporting improvements on AMPA compared to IVIG. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:05:57We see an opportunity to disrupt a blockbuster market bringing transformative benefits to patients with MMN and now CIDP as well, which is why we are 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 EMPA to bring a safe treatment option forward in diseases for the lectin and classical pathways are at play. Lastly, we look forward to the first proof of concept data from our third molecule, argenx 119 in CMS. By cocreating with the world experts in musk biology, we have built a molecule that has the potential to alleviate diseases hallmark 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:07:06Slide six. We had a robust field 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, a sweeping IgA antibody and an anti IL6 all have significant therapeutic potential across new autoimmune indications. Our IRT is an incredible productive 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:08:04We 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. Karl GubitzChief Financial Officer at argenx SE00:08:34Thank you, Tim. Slide seven. Karl GubitzChief Financial Officer at argenx SE00:08:36The fourth quarter and the full year 2024 financial results are detailed in the press release of this morning. Product net sales are consistent with our pre announcement in January at seven thirty seven million dollars for Q4 and $2,200,000,000 for the full year. This brings total operating income in the fourth quarter to $761,000,000 and $2,300,000,000 for the full year. The product net sales represents 29% quarter over quarter growth and 98% growth compared with the same quarter from the prior year. The product revenue breaks down by region to $649,000,000 in The U. Karl GubitzChief Financial Officer at argenx SE00:09:22S, Twenty Seven Million Dollars in Japan, Forty Nine Million Dollars 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. Karl GubitzChief Financial Officer at argenx SE00:09:50Next slide. Cost of sales were $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 Vibcar Tytrulio, 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. Karl GubitzChief Financial Officer at argenx SE00:10:29Total operating expenses in Q4 are $658,000,000 an increase of $83,000,000 compared with 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 an operating loss for the 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 FX on our non U. S. Denominated cash balances. Karl GubitzChief Financial Officer at argenx SE00:11:23Income 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 12/31/2024, of which $725,000,000 dollars relates to a one time non recurring recognition of previously unrecognized deferred tax assets existing as of 12/31/2023. We made the decision to recognize the deferred tax asset because of our assessment that is probable that 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. Karl GubitzChief Financial Officer at argenx SE00:12:39Our 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. Karen MasseyChief Operating Officer at argenx SE00:13:19Thank 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. Karen MasseyChief Operating Officer at argenx SE00:13:48Our growth was fueled by both MG and CIDP and it's encouraging to see how VIVVAC continues to transform outcomes as we broaden and deepen our reach in the MG community. And at 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. Karen MasseyChief Operating Officer at argenx SE00:14:26VIVGAR HYTURO played a key role in reaching patients earlier in the treatment paradigm and predominantly in patients brand new to VIVGAR rather than switches from IV. Some additional growth was supported by a halo effect from the CIDP launch where we saw neurologists whose first read scripts in CIDP 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 through label extension studies. We have a long term strategy to enable continued adoption of this gut in earlier treatment lines and this remains our key And we'll further build this confidence by investing in evidence generation. And we'll further build this confidence by investing in evidence generation. Karen MasseyChief Operating Officer at argenx SE00:15:25Real world data efforts are underway to evaluate reduction in steroid use, safety in new patient populations and dosing through our ADAPT next study, which we plan to share at upcoming medical conferences. Innovation on RUTU'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 pre filled 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. Karen MasseyChief Operating Officer at argenx SE00:16:13Lastly, we see additional opportunity to address the unmet need in the MG community by expanding our label into seronegative and ocular MG. ADAPTseron is the first of our Phase three studies to read out this year. And we have ample real world and clinical datasets 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. Karen MasseyChief Operating Officer at argenx SE00:16:46Next slide. We're very encouraged by the continued momentum of the VIVGARD HYTULO launch in CIDP. 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. Karen MasseyChief Operating Officer at argenx SE00:17:18Her physician was dedicated to improving this burden and suggested a switch to VIVGAR HYTULO. 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 HYTULO 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 were empowered to demand more from their treatment. I'm incredibly proud of the team for building a solid foundation to get us off to this strong start to ultimately reach our target addressable population of 12,000 patients. Karen MasseyChief Operating Officer at argenx SE00:18:01Our 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 users. As of year end, we had approximately 1,000 patients on treatment with the majority of these falling within our initial addressable population. Those who are not sufficiently controlled for all who experience side effects on IVIG or steroids. Karen MasseyChief Operating Officer at argenx SE00:18:36Most urologists will treat patients for twelve weeks to assess this response to VIBGAR. So 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 MG playbook to consistently generate data to build physician support of Hytulo while also empowering patients to ask for more from their CIDP treatment. Next slide. Karen MasseyChief Operating Officer at argenx SE00:19:06We 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, we have launched in most of the major markets ex U. S. Karen MasseyChief Operating Officer at argenx SE00:19:21And 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 approvals in South Korea and one that is personally very close to my heart, Australia. Earlier, I 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. Karen MasseyChief Operating Officer at argenx SE00:20:01Feedback 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. Karen MasseyChief Operating Officer at argenx SE00:20:16And 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 relationships in the neurology community with over 3,500 VIVGAR prescribers, which we'll leverage as we advance into our next launch wave with seronegative and ocular MG. The impressive data from the ARDA study in MMN for IMPASA PROVART 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 IMPAZ approved at 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. Karen MasseyChief Operating Officer at argenx SE00:21:07Patients continue to be discouraged with the symptom burden and the lack of treatment options. So the Phase three data 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 neurology into rheumatology with subtypes across both therapeutic areas. We aim to leverage our neurology 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. Karen MasseyChief Operating Officer at argenx SE00:21:51Tim? Tim Van HauwermeirenCEO & Executive Director at argenx SE00:21:53Thank you, Karen. Slide 14. I want to extend my sincere appreciation to the argenx team, including our board for their 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 that our continued innovation in the autoimmune space maintains its 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:22:36Importantly, 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 to your questions. Operator00:22:52Thank you. We will now begin the question and answer session. Your first question comes from the line of Tazeen Ahmad from Bank of America. Your line is open. Tazeen AhmadMD - US Equity Research at Bank of America00:23:14Hi, good morning. Thanks for taking my questions. Mine are 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 there potentially could be this more convenient option? Tazeen AhmadMD - US Equity Research at Bank of America00:23:36And if you're looking for switches to occur, would that be, gradual or would that be a bolus effect that we should see upon approval? And then I have a follow-up. Karen MasseyChief Operating Officer at argenx SE00:23:50Yes. Thanks for the question, to the end of the interest. We're really excited, for the upcoming CFS, PDUFA date in April, and potential approval. So here's what I would say. I don't think we're seeing pent up demand. Karen MasseyChief Operating Officer at argenx SE00:24:03In 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, and, but what we do expect is that free filter range for self injection will open up, both the prescriber base and the patient, that will consider VivGut as an option for either MG or CIDP. 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. Karen MasseyChief Operating Officer at argenx SE00:24:39It's not specifically a switch strategy that we're pursuing, to the second part of the question that you asked. Rather, we want to focus on expanding, outreach to prescribers and to patients. Thanks for the question. I think you had a follow-up. Tazeen AhmadMD - US Equity Research at Bank of America00:24:52Yes. 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 difference? Karl GubitzChief Financial Officer at argenx SE00:25:06Hi, Tazir. It's Carl here. Thank you for your questions. Consistent with prior launches, we will provide more color on the price at the time of the launch. But let's provide some framework on how we think about it. Karl GubitzChief Financial Officer at argenx SE00:25:19We'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 Organixx. Thank you for your question. Operator00:25:40Your next question comes from the line of Alex Thompson from Stifel. Your line is open. Alex ThompsonManaging Director at Stifel Institutional00:25:45Hey, great. Thanks for taking our 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? Alex ThompsonManaging Director at Stifel Institutional00:26:03What you would expect to see, upon the launch this year? Thanks. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:26:08Thank you for the question, Alex. Yes, the dynamics for self administration and FDA approval of self administration of course, 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 patients. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:27:04All 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 that the VVAs will be phasing out. Thank you for your question. Operator00:27:26Your next question comes from the line of Derek Archila from Wells Fargo. Your line is open. Derek ArchilaAnalyst at Wells Fargo00:27:32Hey, good morning and thanks for taking the questions. Just one from us. I guess 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? Derek ArchilaAnalyst at Wells Fargo00:27:50Thanks. Karen MasseyChief Operating Officer at argenx SE00:27:50Yes. Thanks for the question, Derek. This is Karen. I'm happy to take it. Karen MasseyChief Operating Officer at argenx SE00:27:54So, what I how I think about it is what I was mentioning before in MG, continued momentum and continued strong uptake in line with the strategy that we have of moving earlier lines in the treatment paradigm and broadening the prescriber base. Well 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 we are doing seeing the benefit revert verifications. Karen MasseyChief Operating Officer at argenx SE00:28:32That 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. Derek ArchilaAnalyst at Wells Fargo00:28:45Thank you. Operator00:28:47Your next question comes from the line of Yaron Werber from TD Cowen. Your line is open. Yaron WerberManaging Director, Senior Biotechnology Analyst at Cowen and Company00:28:54Great. Maybe a couple of questions. One for Carl. When the VPAs expire because of Part D, how does that work? I assume access stays the same or do you need to renegotiate? Yaron WerberManaging Director, Senior Biotechnology Analyst at Cowen and Company00:29:09And then for Karen, for the first twelve weeks on CODP, are physicians actually doing incants and are they actually looking at are they actually assessing formally whether patients are improving or I imagine they're just keeping them on therapy and if they're really not benefit they'll take them off? Thank you. Karl GubitzChief Financial Officer at argenx SE00:29:29Durin, thank you for your question. On the VBAs, with BFS, 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. And as it is a pharmacy benefit, our expectation is that BBAs will not be part of those contracts and so therefore it will phase out over time. Thank you for your question. Karen MasseyChief Operating Officer at argenx SE00:29:58Thanks, Carl. And, and yet 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 excuse me so more generally the doctors will have a conversation with their patient they're using more simple assessments to determine how their disease is being controlled by Vivint and then making an assessment on response. Operator00:30:33Your next question comes from a line of Victor Flock from BNP Paribas. Your line is open. Victor Floc'hEquity Research Analyst at BNP Paribas00:30:41Hi. Thanks so much for taking my question. Viktor Flock from Mindyparabegasan. 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 that 2026 is going to be quite strong. Victor Floc'hEquity Research Analyst at BNP Paribas00:30:59But in the meantime, would you say that investors are overlooking the potential for the SIR negative Phase II trial to significantly expand MG as a small opportunity as well as PFS ability to further drive your lines 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 the administration has been for iTrudo's penetration ex U. S? I know you don't report any sales breakdown and that there are structural differences between U. S. Victor Floc'hEquity Research Analyst at BNP Paribas00:31:33Market and ex U. S. But just trying to understand how self administration on label in U. S. Could meaningfully drive sales? Victor Floc'hEquity Research Analyst at BNP Paribas00:31:41Thanks so much. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:31:43Thanks and great to hear from you in the call. You're right to Carla that we do have self administration already for Fevigar Haktulo outside of The United States. And I will let Karan comment on, you know, why that is important for physicians and patients. On use flow, this is an incredibly busy year from an execution point of view. I mean, pushing 10 Phase three clinical trials and 10 Phase two clinical trials forward at this speed I think is a very serious task. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:32:13But in the first half of the year, I think EFS is important, which hopefully self administration as Karen will explain in a minute. And then you're correct to call out, you know, the significance of hopefully a positive readout in seronegative MG patients. There's a significant volume of patients out there in higher unmet medical needs. We have seen in Japan, you know, how important that patient population actually is and how successful Vivigart actually is in treating these patients. So that could be a very important force or driver in maintaining the momentum we were alluding to. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:32:46And then I would also like to call out an important proof of concept study in lupus nephritis second half of this year. So Karim, do you want to continue with the importance of self administration? Karen MasseyChief Operating Officer at argenx SE00:33:01Yeah, 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, to self administration. There are some patients that choose to stay with IV. That's what makes, that's what fits with their lifestyle. Karen MasseyChief Operating Officer at argenx SE00:33:31Perhaps 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 that same experience, will come through in The U. S. If we get approval for self injection on April 10. Karen MasseyChief Operating Officer at argenx SE00:34:12Thanks for the question. Operator00:34:15Your next question comes from the line of Akash Tewari from Jefferies. Your line is open. Amy LiSVP Equity Research at Jefferies00:34:22Hey, this is Amy on for Akash. 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 the probability of success across each of the subsets now? And then finally, wanted to get your thoughts on the abinutuzumab data and how that reads across Amy LiSVP Equity Research at Jefferies00:34:44to your lupus nephritis trial? Tim Van HauwermeirenCEO & Executive Director at argenx SE00:34:48So, in myositis, 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 are 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 leukosnivitis, we see a number of measurements being tested. Whatever the data which we see, I think there's ample of room for improvement. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:35:29There is a significant unmet medical need. There is a need for a toolbox to treat these patients and I don't think there is going to be one size fits all. So let's focus on our data. We have strong conviction in the biology and we are testing that mechanism of action now in Phase two. So let the data speak. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:35:47But Amy, thank you for the questions. Operator00:35:56Your next question comes from the line of Rajan Sharma from Goldman Sachs. Your line is open. Rajan SharmaExecutive Director at Goldman Sachs00:36:01Hi. Thanks for taking my question. I'll keep it to just one. So just to understand some of the underlying dynamics in myasthenia gravis. So we know that back at launch of VIVGAR, you said that the addressable market was about seventeen thousand patients and you think there's an additional 25,000 that will come from growth in the biologics market by '2 thousand and '30. Rajan SharmaExecutive Director at Goldman Sachs00:36:24So 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? Thank you. Karen MasseyChief Operating Officer at argenx SE00:36:38Yes. 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 17000, since the launch of this gut. So we do think there has been market expansion. Karen MasseyChief Operating Officer at argenx SE00:37:03And 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 earlier line. And this guide is, let's say, leading the charge on that as the number one prescribed biologic. We shared the statistic that sixty percent of patients are actually coming directly to Vivgut from orals. So that demonstrates that we're starting to penetrate, that twenty five thousand. Karen MasseyChief Operating Officer at argenx SE00:37:33But we believe that there's quite a long way to go and that we can maintain that consistent and steady growth. Certainly, pre filled syringe for self injection will help us with that. Thanks for the question. Operator00:37:46Your next question comes from a line from Susan Van Verheusen from Kempen. Your line is open. Suzanne van VoorthuizenHead of Life Sciences Equity Research at Van Lanschot Kempen00:37:53Hi, team. This is Suzanne Van Verhuizen. Thanks for taking my question. I was wondering if you can elaborate a bit on your longer term thinking of FcRn franchise. I guess you're getting to the point where investing in more Phase two trials for FIFGARD may not always make sense and you perhaps look towards the next generation FcRn two thirteen. Suzanne van VoorthuizenHead of Life Sciences Equity Research at Van Lanschot Kempen00:38:13So on two thirteen clinical developments, do you see possibilities for shorter development timelines? What are elements that you can leverage from having developed safeguards? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:38:28Yes, 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 a molecule like like DeepGard. So, I think developing a molecule like argenx two thousand one hundred and thirteen gives us optionality and we said this is the first of, you know, successor molecules. It basically unfolds optionality. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:38:59I 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 CIDP, ITP and the other indications to come that actually you could leave us that know how and and and and 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 we go based on data. We are really focused now on generating the Phase I data second half of this year, which will tell us a lot about the potential of this molecule going forward. Thanks for the question. Operator00:39:46Your next question comes from the line from Vikram Parohit from Morgan Stanley. Your line is open. Vikram PurohitAnalyst at Morgan Stanley00:39:53Hi, good morning. Thank you for taking our question. We'll keep our question focused Vikram PurohitAnalyst at Morgan Stanley00:39:57on 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 VIVGUARD potentially could expand the opportunity beyond, the IV, the Vikram PurohitAnalyst at Morgan Stanley00:40:14subcu and the PFS? Thanks. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:40:18Yes. Thank you. Vikram, the significance of the auto injector 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 basically 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:40:44So in an attempt to continue to innovate in our core market, 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 prefilled syringe. It is a very innovative product, thanks to, you know, the technologies we leverage in the formulation and the technologies we leverage for the containers. So significant innovation and I think a significant driver for the business. Stay tuned on the auto injector. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:41:13We'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 the year we're all aiming for and I would say stay tuned. Vikram PurohitAnalyst at Morgan Stanley00:41:25Thank you. Operator00:41:27Your next question comes from the line of Andy Chen from Wolfe Research. Your line is open. Emma GutsteinEquity Research Associate at Wolfe Research00:41:33Hi. 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. Emma GutsteinEquity Research Associate at Wolfe Research00:41:44Is IVIG succeeded in early lines? Are there signs of early standard care transformation, maybe docs performing VIVGART over IVIG? Just any insight would be great. Thank you. Karen MasseyChief Operating Officer at argenx SE00:41:57Yes. 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. And what we consistently hear, the feedback from the community, whether it be neurologists, patients, caregivers, is that there is a higher treatment burden and a higher disease burden than they had realized. Karen MasseyChief Operating Officer at argenx SE00:42:21So bringing the first innovation in thirty years, is making a big difference. And I do think to your question, over time, 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. Karen MasseyChief Operating Officer at argenx SE00:42:39Eighty five percent of our patients are switched from IVIG and that's exactly where we thought we would be. So we're pleased with the momentum so far. Operator00:42:52Your next question comes from the line of Yatin Sineya from Guggenheim. Your line is open. Analyst00:42:58Hi, this is Selma for Yatin. Thanks for taking our question. So for the seronegative endocular MG trials, what's the dosing regimen in those studies? And based on your off label use of VipGuard in this population, would you anticipate that these patients will need a similar number of annual cycles at zero positive GMT? Or will they need more frequent dosing? Analyst00:43:21And finally, how should we think about pricing in these indications? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:43:27I think the answer to this question, thank you for the question, is very simple. We don't design and we don't anticipate any difference dosing in seronegative or ocular MG patients as compared to the generalized MG patients which are acetylcholine receptor antibody positive, which we have currently on label in The States. And we also don't anticipate any real pricing difference. ID is that this is label expanding and is just broadening the offering to the MG community. So you can assume for the models exactly the same parameters. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:44:00Thank you for the question. Operator00:44:03Your next question comes from the line of Samantha Simenco from Citi. Your line is open. I apologize, we lost the connection. Your next question comes from the line of Matt Phipps from William Blair. Your line is open. Matt PhippsGroup Head - Biotechnology at William Blair00:44:22Hi. 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 component be looked across all patients? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:44:41Yes, Matt, I think you're spot on. You will want to see a minimum representation of every subset in that Phase three registration trial in order to draw, you know, database conclusions, you can then also discuss with the FDA. So I think your underlying assumption is correct. Thank you. Operator00:45:02Your next question comes from the line of Gavin Clark Gartner from Evercore ISI. Your line is open. Gavin Clark-GartnerDirector - Biotechnology Equity Research at Evercore ISI00:45:09Hey, 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? Karl GubitzChief Financial Officer at argenx SE00:45:27So, I think Gavin, it's Karl here. I think, we sell price negotiations which still needs to take place for the PFS, but our expectation is that for pharmacy benefit that you would keep incremental discounts because that's what 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, those, yes, there won't be gaps. Thank you for your question. Operator00:46:01Your next question comes from the line of Samantha Simenka from Citi. Your line is open. Samantha SemenkowVice President at Citi00:46:07Hi, good morning. Are you able to hear me? Tim Van HauwermeirenCEO & Executive Director at argenx SE00:46:10Yes, we can hear you. Samantha SemenkowVice President at Citi00:46:12Perfect. Thanks very much for taking the question. I'm wondering, can you speak to your confidence in FDA granting the self administration for the PFS? And perhaps you can just remind us on FDA's concerns surrounding self administration for the butterfly needle process and how that's factored into your strategy as you look to secure self administration for the PFS? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:46:34Yes. So, taking the step back, we feel we submitted a very strong data set to the FDA with regards to the pre fill syringe including I think a very solid human factor study which is taking into account the typical questions a regulator may have on, you know, 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 where 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:47:19So 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. Operator00:47:35Your next question comes from the line of Thomas Smith from Leerink Partners. Your line is open. Thomas J. SmithSenior Managing Director, Immunology and Metabolism at Leerink Partners00:47:44Hey guys, good morning. Thanks for taking our questions. Tim, you called out LN as an important proof of concept readout in the second half of this year. I know that's a study that's being conducted by your partner Xi in China and they just recently completed enrollment. I was just wondering if you have Thomas J. SmithSenior Managing Director, Immunology and Metabolism at Leerink Partners00:47:59a sense of sort of Thomas J. SmithSenior Managing Director, Immunology and Metabolism at Leerink Partners00:48:01the 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. Thanks. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:48:16Yes, Thomas, thank you for the question. First thing I want to do is applaud Zai as a reliable and high quality development partner that are not only involved in these Phase II proof of concept studies, but are also involved in a lot of the Phase III global registration trials with with SPIN and high quality. So a very strong partnership. And specifically to LN, 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, LN patient population with significant unmet medical needs. There are some variations in the type of treatments these patients undergo. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:48:57But for us, this Phase II and it's a true Phase II is a proof of concept. So the first question we need to answer in this Phase II trial is, are we spot on with this mechanism of action? And when we dramatically reduce phytogenic IgG, do you 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 three registration trial where we will take into account, you know, some of the global treatment regimens which are typically being used. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:49:28So we take it step by step. And for the proof of concept question, I think Sai is perfectly equipped to help us address that question. So we are very much looking forward to the data. Thank you. Operator00:49:42Your next question comes from the line of Leland Gershell from Oppenheimer. Your line is open. Leland GershellManaging Director - Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:49:48Hey, good morning. Thanks for taking our questions. Just a question on 01/2019. 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 one hundred and nineteen and its other indications? Leland GershellManaging Director - Senior Biotechnology Analyst at Oppenheimer & Co. Inc.00:50:07Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:50:09Now I like the question about 119. Thank you for that. As an indication, from genetal myasthenic syndrome is, you know, really in the bull's eye of the biology of this target. Remember, we have been publishing and presenting spectacular data in the DOG7 animal model which is perfectly mimicking the DOG7 mutation in in human beings and that's exactly where we're testing the CMS. Think of, you know, a genetic form of MGA which has overlap with autoimmune MG. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:50:41It's fatiguable. It's typically limb girdle which is being affected, but also the eyes. So we're basically looking for a strong signal that we move the needle in these patients. So I 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're bringing life now the study in SMA. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:51:05I would say that all these 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 argenx one hundred and nineteen. We're very much looking forward to the data, by the way. Thank you for the question. Operator00:51:23Your next question comes from the line of June Lee from Truist Securities. Your line is open. Mehdi GoudarziBiotech Equity Research Analyst at Truist Securities00:51:30Hi, good morning. Congrats on the quarter. This is Mehdi Gudarze on for June. A question related to your early pipeline assets. We appreciate more color on your plans for argenx109 and high IL-six. Mehdi GoudarziBiotech Equity Research Analyst at Truist Securities00:51:48Based on the importance of the target, 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. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:52:08I think you're calling out the strength of the molecule. I think this is a best in class IL-six blocker with bicomolar potency, a sixty to eighty days half life and already proven safety profile, in two Phase 1s actually, 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 through Phase one. We're expecting the Phase one data second half of this year. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:52:50So stay tuned. More to be told on 01/2009 soon. Thank you. Operator00:52:55Your next question comes from the line of Joel Beatty from Baird. Your line is open. Analyst00:53:02Good 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? Analyst00:53:14Thank you. Karen MasseyChief Operating Officer at argenx SE00:53:17Yes. 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 it to be within days that will be out there with PFS for self injection. Operator00:53:40Your next question comes from the line of Doug Laseo from H. C. Wainwright. Your line is open. Douglas TsaoManaging Director at H.C. Wainwright & Co.00:53:49Hi, 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 in ocular MG might affect sort of the treatment paradigm for MG? And whether you sort of might see that push earlier, obviously, because some of the patients present with ocular symptoms first, but sort of really you know, whether clinicians might view it as sort of disease modifying therapy at that stage? Douglas TsaoManaging Director at H.C. Wainwright & Co.00:54:21Thank you. Karen MasseyChief Operating Officer at argenx SE00:54:23Yes. Thank you for the question. And I like how you frame it up as disease modifying. Look, we'll have to let the data speak. But the way that I think about it is very much aligned with how you're thinking about it. Karen MasseyChief Operating Officer at argenx SE00:54:36Our strategy is that we believe that treatment with Vivka in earlier 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, 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 time, we can imagine that you could see data in the real world with where we're able to delay that generalization. Karen MasseyChief Operating Officer at argenx SE00:55:09And 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. Operator00:55:27Your next question comes from the line of Manos Maserakis from Deutsche Bank. Your line is open. Manos MastorakisAnalyst at Deutsche Bank00:55:34Thank you for taking my question. Manos Maserakis from Deutsche Bank. So how do you think about the potential for competitors to further improve upon clinical outcomes in CIDP above efgartigimod's outcomes? And do you believe complement inhibitors have a role to play in this space? Thank you. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:55:56Yes. Thank you for the question. I think in CIDP, we have written history because we have shown for the first time that actually 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 it is seventy percent response rate, a safety profile which is very much in line with the known safety profile which we all recognize is pretty unique in this world. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:56:25And then of course we are 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 Maesthenia. We were also first to market. Tim Van HauwermeirenCEO & Executive Director at argenx SE00:56:45Is that a role for complement? Karl GubitzChief Financial Officer at argenx SE00:56:47I think that is. That's also why we're advancing empasiprobot in CIDP despite the fact that we printed the highest response rate average at seventy percent. That is a thirty percent of patients, you know, which have medical needs and were not served in the ATHIEVE 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 complement and which do not recycle through FcRn. So I think we're unraveling the answer to your question. Karl GubitzChief Financial Officer at argenx SE00:57:21I think empaciprobar really deserves the short on goal and we're very keen to start this study and look at complement data. So there's a lot to be unpacked and a lot to be developed in CIDP. Thank you. Operator00:57:36And we have reached the end of our question and answer session. This concludes today's conference call. Thank you for your participation. You may now disconnect.Read moreParticipantsExecutivesBeth DelGiaccoVP and Global Head of Corporate Communications & Investor RelationsTim Van HauwermeirenCEO & Executive DirectorKarl GubitzChief Financial OfficerKaren MasseyChief Operating OfficerAnalystsTazeen AhmadMD - US Equity Research at Bank of AmericaAlex ThompsonManaging Director at Stifel InstitutionalDerek ArchilaAnalyst at Wells FargoYaron WerberManaging Director, Senior Biotechnology Analyst at Cowen and CompanyVictor Floc'hEquity Research Analyst at BNP ParibasAmy LiSVP Equity Research at JefferiesRajan SharmaExecutive Director at Goldman SachsSuzanne van VoorthuizenHead of Life Sciences Equity Research at Van Lanschot KempenVikram PurohitAnalyst at Morgan StanleyEmma GutsteinEquity Research Associate at Wolfe ResearchAnalystMatt PhippsGroup Head - Biotechnology at William BlairGavin Clark-GartnerDirector - Biotechnology Equity Research at Evercore ISISamantha SemenkowVice President at CitiThomas J. SmithSenior Managing Director, Immunology and Metabolism at Leerink PartnersLeland GershellManaging Director - Senior Biotechnology Analyst at Oppenheimer & Co. Inc.Mehdi GoudarziBiotech Equity Research Analyst at Truist SecuritiesDouglas TsaoManaging Director at H.C. Wainwright & Co.Manos MastorakisAnalyst at Deutsche BankPowered by