argenex Q2 2024 Earnings Call Transcript

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Provided by Quartr
July 25, 2024

Key Takeaways

  • Argenx reported Q2 product net sales of $478 million, a 20% quarter-over-quarter increase, ended the period with $3.1 billion in cash, and narrowed its projected 2024 cash burn to under $500 million.
  • The VIVGARD franchise in myasthenia gravis marked its 10th consecutive quarter of revenue growth and Argenx plans label-enabling studies to expand use into earlier treatment lines and seronegative and ocular MG populations.
  • Following its June approval, Argenx has initiated the CIDP launch with a broad label, reaching 25% of key targets within 14 days and receiving 20% of scripts from prescribers new to VIVGARD, with first CIDP revenue expected in Q3.
  • At R&D Day, Argenx outlined its Vision 2,030 to deliver five molecules into Phase 3, advance to 10 labeled indications, and treat 50,000 patients globally, with multiple new registration trials set to begin this year.
  • Despite a statutory net profit of $29 million in Q2 thanks to a deferred tax benefit, Argenx recorded an $45 million operating loss, underscoring that operational profitability has not yet been achieved.
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Earnings Conference Call
argenex Q2 2024
00:00 / 00:00

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Operator

At this time, I'd like to turn the conference over to Investor Relations, Beth DelGiacco. Please go ahead.

Beth DelGiacco
Head of Investor Relations at Argenx

Thank you. A press release was issued earlier today with our half-year 2024 financial results and second-quarter business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I would like to remind you that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, the potential success of our product candidates, financial projections, and upcoming milestones. Actual results may differ materially from those indicated by these statements. Argenx is not under any obligation to update statements regarding the future or to confirm their statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer; Karl Gubitz, Chief Financial Officer; and Karen Massey, Chief Operating Officer. I'll now turn the call over to Tim.

Tim Van Hauwermeiren
CEO at Argenx

Thank you, Beth, and welcome, everyone. I'll begin on slide three. Last week, many of you joined us for our R&D Day, where we laid out an ambitious Vision 2030 and shared a comprehensive overview of the growth opportunities ahead in order to achieve this vision. We are in a very strong position today to generate substantial value across our business, investing in our internal innovation engine, executing on our differentiated multi-asset pipeline, and building on the commercial success we have achieved in our first 10 quarters of launch. This is a team that delivers on our innovation mission time and time again, all towards our goal to transform autoimmunity and reach 50,000 patients globally. Given the recency of this update, we will aim to keep our prepared remarks brief and focus primarily on the second-quarter dynamics.

Tim Van Hauwermeiren
CEO at Argenx

But first, I'd like to highlight key themes that emerged from the R&D Day in the context of our Vision 2030. Slide four. The first theme is around how we innovate, centered on a model of co-creation. This model has been core to our growth since our founding and still exists in the most obvious form today with our Immunology Innovation Program. We have a strong track record of success in building out our differentiated pipeline, including eight out of 12 molecules that demonstrated human proof of concept and nine that are first-in-class targets. We have no shortage of opportunity with identifying novel targets and believe our overall approach sets us up to drive continued pipeline expansion for years to come. A second theme is the new standard we are setting with VYVGART in MG.

Tim Van Hauwermeiren
CEO at Argenx

We are currently leading advanced biologic in MG and have delivered 10 consistent quarters of growth since our initial launch. We are making excellent progress across all key indicators and are exactly in line with our internal long-term thinking of the MG marketplace. We think this is a big opportunity, and we have a strategic plan to reach more patients as we move into earlier lines of treatment and broaden to new populations through label-enabling studies in seronegative and ocular MG patients. We will use the same playbook for CIDP and are happy with the early days of the launch. We got the best possible label, which puts us in a strong position for continued growth as we work to get the access piece in place. Third, we laid out our next wave of indications and expect to initiate four new registration trials this year across VYVGART and Empasiprubart.

Tim Van Hauwermeiren
CEO at Argenx

We set the bar high with a medicine like VYVGART, but we're thrilled to use the R&D Day to put Empasiprubart more in the spotlight. This is a second pipeline in a product opportunity, and we were able to show phenomenal patient data in MMN, which we see as the first of many indications where we hope to drive transformational impact. Slide five. The progress we have made across our business over the quarter moves us another step closer towards achieving our 2030 vision to bring five molecules to phase three, advance our late-stage pipeline to 10 labeled indications across our molecules, and to ultimately have 50,000 patients on an Argenx medicine by 2030. While ambitious, we believe we're well-positioned to deliver on this goal with a continuum of innovation from discovery all the way through commercial.

Tim Van Hauwermeiren
CEO at Argenx

Underpinning our incredible success to date is the strong financial health of our business, which will enable us to continue delivering on our innovation mission, ultimately driving value for our patients and our shareholders. With that, I would like to turn over the call to Karl.

Karl Gubitz
CFO at Argenx

Slide six. Thank you, Tim. The second quarter 2024 financial results are detailed in the press release of this morning. Total operating income in the second quarter is $489 million. This reflects $478 million in product net sales and $12 million in other operating income. In the second quarter, the $478 million in product net sales is attributed solely to MG patients. We received the CIDP approval on June 21st, and our teams were immediately in action the next day. It takes time at the start of a launch to get patients through the funnel from script to injection. So the first CIDP revenue will be a third-quarter event. Product net sales of $478 million represents 20% growth quarter-over-quarter compared to Q1 2024, which we know with a biologic is typically a more challenging quarter due to insurance re-verifications and loss of shipping days with weather and holidays.

Karl Gubitz
CFO at Argenx

The product revenue breaks down by region to $407 million in the U.S., $20 million in Japan, $35 million in EMEA, and $14 million from product supply to Zai Lab in China. Operating expenses in Q2 are $535 million, an increase of $29 million compared with Q1 2024. SG&A expenses are $256 million in Q2, which is an increase of $20 million compared to Q1. The increase reflects a full-quarter impact of an expansion of a customer-facing organization in the U.S., as well as incremental expenses to prepare for the CIDP launch. R&D expenses on the continued investment in our pipeline are $225 million in the second quarter, broadly in line with the previous quarter. The operating loss of a quarter of $45 million is offset by financial income of $30 million and the tax benefit of $44 million.

Karl Gubitz
CFO at Argenx

The tax benefit is a result of a deferred tax asset recognized in our U.S. legal entity due to intra-group inventory movements. It is a temporary timing difference and will reverse in future quarters. Overall, we saw a net profit for the quarter of $29 million and earnings per share of $0.49. It is an important distinction, but the net profit was primarily driven by the recognition of a deferred tax asset, and we still had an operating loss for the quarter of $45 million. We are on a clear path to profitability, but we are not there yet. We continue to have a strong balance sheet with $3.1 billion in cash. Based on our year-to-date cash burn of $77 million, we are updating our 2024 cash burn guidance from approximately $500 million to less than $500 million. Our guidance on expenses remains unchanged.

Karl Gubitz
CFO at Argenx

This puts us in a strong position to invest in innovation across our business, and we have many opportunities to do so. There's a sizable opportunity in our current markets, in new markets with our VYVGART franchise, with our current pipeline, and through our Immunology Innovation Program to expand our pipeline. This is how we will set ourselves up for a sustainable future where we continue to generate significant value for our shareholders. I will now turn the call over to Karen, who will provide details on the commercial front.

Karen Massey
COO at Argenx

Thank you, Karl. Slide eight. I'm very excited by our Vision 2030, especially the ambition we have set for ourselves to impact the lives of 50,000 patients globally and their caregivers. To reach this goal, we will need to expand in a multidimensional way, getting more medicines approved across many indications, product presentations, and geographies. We have a strong commercial playbook in place that delivered in MG and will be leveraging that same approach for CIDP, focusing on evidence generation that matters most to physicians and patients, empowering patients to demand more from their treatments, and last, the need to execute on our strategies with speed and urgency. We know that patients are waiting, and we also know that every day counts in building out our first-in-class leadership position. Slide nine.

Karen Massey
COO at Argenx

Starting with MG, I'm extremely proud of the team who worked really hard to expand our reach into new patients for our 10th consecutive quarter of revenue growth. We said this in Q1 and can reiterate it today that all key indicators of growth are performing well, and the fundamentals to the commercial business are strong. Focusing on the key drivers of growth this quarter, we saw the seasonality impact in Q1 normalizing Q2 with the impressive 17% quarter-over-quarter growth. Within the US, VYVGART Hytrulo continues to attract both new patients and prescribers to the VYVGART franchise. This is important for a few reasons. First, over 50% of new VYVGART Hytrulo patients are coming from orals, and 60% are brand new to VYVGART, which is consistent with our goal to reach early-aligned patients and to expand new patients with VYVGART Hytrulo.

Karen Massey
COO at Argenx

Second, we continue to expand our prescriber base for MG, many of whom have the potential to be CIDP prescribers. This will serve us well in our early conversations with physicians who have grown accustomed to the favorable safety and efficacy profile of VYVGART Hytrulo. Slide 10. We continue to gain traction outside the U.S. as well, where we are focused on securing broad access. We have strong momentum in EMEA, and VYVGART is now available in countries representing 82% of the gMG population in the region. We also continue to see strong growth in Japan, including positive early indicators on the launch of ITP. This launch rolled out rapidly, and 74% of HCPs were made aware of VYVGART in the weeks post-approval.

Karen Massey
COO at Argenx

It is clear that there is a need for innovation in ITP, which is why we are also launching an efficient label-enabling study with VYVGART IV in the U.S. after discussions with the FDA. Lastly, in China, we continue to be very impressed by patient adds each quarter, and now subcutaneous is also available following the approval earlier this month. Slide 11. Even with our strong performance to date, we believe that we're still at the front end of the opportunity in MG. We are seeing the MG market expand, a dynamic that we have seen play out in other rare disease markets when innovation enters the space.

Karen Massey
COO at Argenx

We believe that earlier use of advanced biologics will expand the addressable market significantly and that we can reach broader populations of MG patients with our label expansion studies in seronegative and ocular MG, each of which represents 15% of the total MG population. Based on these evolving dynamics, we have updated our addressable market in MG to 60,000 patients. Slide 12. Following our approval in June, we recognize that all eyes are on CIDP, and we share your excitement. We are thrilled with the broad label that we got, which will support use across the treatment paradigm. Now, we're leveraging our MG launch playbook to maximize our impact in CIDP, driving rapid adoption with neurologists based on the strength of our data, empowering patients, and working diligently with payers to put the necessary policies in place to secure access as quickly as possible.

Karen Massey
COO at Argenx

Reception has been incredibly positive with physicians, particularly on the strength of the data in improvement in function. We've already reached 25% of our key targets within 14 days of launch, and 20% of the prescriptions we're receiving are from new prescribers to VYVGART. Many of the prescribers are starting multiple patients. Right now, our priority is to bring as many patients into the top of the funnel as possible. Once an enrollment comes in, payer approval at this stage takes a few weeks, after which patients can be scheduled to their first injection. This shows the importance of getting payer policies in place quickly, and as this happens, the time from script to injection gets shorter. Based on where we are today, we're making good progress with payers, and we're tracking to plan. Slide 13.

Karen Massey
COO at Argenx

Looking forward, we have an ambitious plan to successfully execute multiple launches across our pipeline in order to reach 50,000 patients in 2030. We're on track to start multiple phase III studies before the end of the year, and each of these brings us a step closer to reaching new autoimmune indications where there is a high unmet need. The TED registrational study has already started, and we see an opportunity here to provide a differentiated and targeted therapy with favorable safety. We look forward to initiating a phase III study in Sjögren's before year-end, following the positive signal we saw in our phase II proof of concept study. There are no approved treatments for Sjögren's patients, and we know the disease goes well beyond sicca symptoms and can affect patients' ability to work and complete daily tasks, particularly the fatigue.

Karen Massey
COO at Argenx

This is a sizable opportunity, and while data will drive the specific target population, we know that there are 100,000 moderate to severe Sjögren's patients in the U.S. Last, we also look forward to decisions in myositis and BP on whether to advance to phase III later this year. Finally, before year-end, we will start a phase III trial with our second molecule, Empasiprubart, in MMN. This is an indication that fits perfectly into our neuromuscular focus, and it is another indication where the unmet need is high, and IVIG is the only approved treatment. The data we generated in phase II were tremendous and very meaningful to patients. We demonstrated consistent improvement in grip strength, and in cohort 1, 94% of patients felt better on Empasiprubart than they did compared to their peak with IVIG.

Karen Massey
COO at Argenx

Similar to MG and CIDP, we believe this is an underdeveloped market, likely to grow over time as more innovation enters. Overall, this is an exciting time for the company. We've seen phenomenal growth to date, and we're eager to continue with this momentum as we enter into the second half of this year, applying innovation to every aspect of our business to reach even more patients. I'll turn it back to you, Tim.

Tim Van Hauwermeiren
CEO at Argenx

Thanks, Karen. Slide 14. I'm proud of the argenx team and their tireless commitment to changing the lives of patients through our science. We are perfectly positioned with the right team and the right approach to execute on the broad opportunity ahead of us. We will continue to lead with the strength of our data and deep knowledge to address the sizable MG opportunity ahead, and we'll apply the same rigor with CIDP. And this is just the beginning. We are eager to raise the bar for how autoimmune diseases are treated as we continue to expand our horizons, embarking on new paths to create long-term value for patients and shareholders. Thank you for your time today. I would now like to open the call to your questions.

Operator

Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your questions, simply press star one again. We'll take our first question from James Gordon at J.P. Morgan.

James Gordon
James Gordon
Executive Director of European Pharma Equity Research at JPMorgan

Hello, James Gordon, J.P. Morgan. Thanks for taking the questions. Two questions, please. First question was on VYVGART performance in Q2 and the extent to which we can extrapolate that to Q3. So sales were up $79 million, which was a strong performance. But how much, if any, would you say was one-off phasing that we should sort of take out if we're thinking about what the underlying performance would be? And if we're thinking about doing our Q3 modeling, how careful do we need to be about any reversals or seasonality, or can we make quite a strong extrapolation from how well VYVGART's done today? That's the first question, please. The second question was phase III initiation for ITP, and I saw a comment or heard a comment about this being an efficient trial. How might this trial differ from the previous two phase IIIs you've done in ITP?

James Gordon
James Gordon
Executive Director of European Pharma Equity Research at JPMorgan

Can you expedite it if it's an efficient trial? Would it be going for a smaller patient population in some way or a similar size population, just a different design?

Tim Van Hauwermeiren
CEO at Argenx

Thank you, James. Thank you for asking these two questions. I would like to hand over to Karen to comment on the underlying dynamics of the business and how to see the overall trends in our VYVGART MG business first, and then I will take the question on the ITP study in phase III. Karen, why don't you go ahead with question one?

Karen Massey
COO at Argenx

Thanks, Tim. And thanks for the question and for recognizing, I think, like you, I'm really pleased with the results of this quarter. The way that I would think about it is that when you look at the first half of the year in totality, what you see is that we maintain that consistent momentum that we've had since launch. So we've had 10 quarters of pretty consistent growth. I would take that longer-term view as I was looking to the future if I was you. And I'm confident that we will continue that consistent momentum. The underlying dynamics are strong. We continue to get early-aligned patients. The majority are coming directly from the orals. We're growing both VYVGART and Hytrulo, and we are broadening that prescriber base, which also served us well for the CIDP launch.

Karen Massey
COO at Argenx

So I would say think about consistent momentum and growth as we've seen over the last 10 quarters. I'll hand it back to you, Tim.

Tim Van Hauwermeiren
CEO at Argenx

Thank you, Karen. Let me briefly comment on the ITP study. First of all, I would like to take a step back and remind the audience about the advanced IV study, but I think we had a very impressive efficacy with an IWG score of more than 50% in a pretty effective patient population and a physician community, which was excited also about the very clean safety profile. We observed the patients in our open label extension study. They continue to do actually very well on ITP, and also the Japan launch of ITP is actually going according to plan. So the task we gave to the team was to sit down with the FDA, go through all the data, and propose a smaller confirmatory study in order to push the ITP indication over the finish line. I think they succeeded in doing that.

Tim Van Hauwermeiren
CEO at Argenx

By leveraging all the insights and the know-how we have on the disease, by actually proposing an alternative primary endpoint, which allows for a smaller confirmatory study, we think we're on track to start a smaller ITP trial before the end of the year, where I think we will be able to push the product over the finish line in that refractory patient population we have been studying all the way. Thanks for the questions.

Operator

Just a reminder, we ask that you please ask one question to allow everyone an opportunity to ask a question. We'll go next to Tazeen Ahmad at Bank of America.

Tazeen Ahmad
Tazeen Ahmad
Senior Equity Research Analyst at Bank of America

Hi, good morning, guys. Here's my one question. I just was curious about the PFS filing. I know you've talked about already having applied officially, but given that there's no PDUFA, we're just curious about how we should expect to think about communication from your team on what part of the application is in process and what back and forth there might be. And do you have an idea of when you would be able to get that full-on approval, given that doctors in particular seem to be excited about having that as an option for patients? Thanks.

Tim Van Hauwermeiren
CEO at Argenx

Thanks, Tazeen. Thanks for being with us this morning. Important questions, simple answer. The filing has been submitted, is accepted, and under review with the FDA. I think we will have a better sense of approval timing when the process unfolds. Stay tuned. We will keep you updated on the progress we make. Thank you.

Operator

Next, we'll move to Allison Bratzel at Piper Sandler.

Allison Bratzel
Allison Bratzel
Equity Research Analyst at Piper Sandler

Hey, thank you for taking the question. Maybe just a follow-up from the R&D day. Could you help us understand just the scope of the data required by FDA that'll be needed for filing in Seronegative and Ocular MG patients? I think you described an ability to leverage existing trial data and real-world data, at least for Seronegative patients, but I've just been getting a bunch of questions on this. So any more color there would be helpful. Thank you.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, and thank you for the question, Allison. So remember that we printed strong results in seronegative MG patients. And as we already have an approval in Japan, but actually in the real world, the product is doing very well in seronegative patients. And we have impressive case reports out of Europe where people have been successfully using the drug in seronegative patients. So we made a commitment to the patient community. We would not give up. And we have been entertaining the dialogue with the FDA on seronegative patients in the background. I think where we could land with the FDA is a pretty fast, elegant study in seronegative patients, which, as Luke called it during the R&D day, is somewhat relaxed P-value. So I think the FDA is taking the existing evidence into account and is allowing us to run such a trial.

Tim Van Hauwermeiren
CEO at Argenx

We think there's a high demand. This is an elegant study, and we will do everything we can to enroll that study as fast as we can. Thanks for the question.

Operator

We'll move next to Rajan Sharma at Goldman Sachs.

Rajan Sharma
Rajan Sharma
Executive Director of Pharma & Biotech Equity Research at Goldman Sachs

Hi. Thanks for taking my question. So just wanting to discuss kind of competitive landscape in myasthenia gravis and how you see VYVGART kind of continuing to differentiate there. There's obviously a busy pipeline. We've got telitacicept in a phase three. Uplizna is also in a phase three. So yeah, could you just kind of discuss how you think VYVGART differentiates relative to those mechanisms? And then longer term, what gives you confidence that VYVGART and the FcRn class more broadly remains kind of the preferred treatment option in early-line patients?

Tim Van Hauwermeiren
CEO at Argenx

Thank you for the question. I will first hand over to Karen to comment on how they see the overall dynamics of this market and how we're building it together. Maybe Karen, you go first, and then I will briefly comment on your differentiation question. Thank you.

Karen Massey
COO at Argenx

Sounds great. Yes, thanks for the question. And look, I think building on what we shared at R&D day last week, we believe that innovation coming to the MG market is good because it grows the impact that we can have for patients, expands the market, expands the number of patients that are treated with advanced biologics earlier as well. So we believe innovation is great for patients, and I think we're seeing that. And we believe we're very well positioned to continue to lead in that growing market. And I think there's a few things that maybe since you asked about the differentiation that I'll touch on. One is around we're first-in-class FcRn, and it's clear that FcRns and certainly VYVGART are being used early line. I said earlier over 50% of our patients are coming directly from the oral.

Karen Massey
COO at Argenx

So that's where the growth is, and we're positioned well there. I think we compete really well on our we have rapid efficacy, but also deep and sustained efficacy, and we have it across cyclical and biweekly dosing regimes. So I think that's a really strong position to be competing from. And don't forget about our real-world safety, the length of that real-world safety, the number of patients as the first-mover advantage. And of course, we have the low treatment burden. So we have both IV and subcutaneous. We have PFS planned. So overall, I think the dynamics in MG are positive. The market is growing, and we're well positioned to maintain and even advance our leadership. I'll hand it back to you, Tim.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, thank you, Karen. I much appreciate it. If you just look at the biology of the disease, it is crystal clear that MG is an IgG-mediated disease. Remember the three most actions of these pathogenic antibodies, complement recruitment just being one of them. And that nicely translates into the clinical data, right? So let me remind you that 80% of VYVGART patients achieve an ADL lower than five, which is a threshold for entering a clinical trial. And that 50%-55% of VYVGART patients achieve minimum symptom expression. So there's always the need in the most refractory line for alternative mechanisms of action because the drug only works in 80% of patients, but it's difficult to go into more detail in absence of data. So let's look at the data to then further understand how that biology really plays. Thanks for the question.

Operator

We'll move next to Derek Archila at Wells Fargo.

Derek Archila
Derek Archila
Managing Director, Co-Head of Therapeutics Research, and Senior Biotechnology Analyst at Wells Fargo

Hey, good morning, and congrats on the progress. Thanks for taking the question. So just can you discuss maybe how the time from payer approval to injection that you're currently seeing during the early part of the CIDP launch compares to what you saw in the early part of the MG launch? Is that similar, or is it different, and maybe a little color on why?

Tim Van Hauwermeiren
CEO at Argenx

Karen, would you mind taking this question, please?

Karen Massey
COO at Argenx

Yeah, happy to take the question. Thanks for it. First of all, just to start with saying we're really pleased with the strong and positive response we're having in CIDP. To answer your specific questions, as enrollments come in, it does take a while for patients to get approved by their payers. It's that period of time that can take a few weeks before they get injected. That's standard for any launch. It's the reason that we're so focused on getting payer policies in place because once the payer policy is in place, that process from script to injection can go more quickly. I would say we're exactly on track where we thought we would be, both in terms of that process as well as, most importantly, the discussions that we're having with payers around getting those policies in place. We're really pleased with the progress.

Karen Massey
COO at Argenx

The team's acting with urgency, and I think we're right on track and pleased with where we're at. I'll hand it back to you, Tim.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, thank you, Karen. I would like to ask a little bit of patience, Derek, because remember what we did for MG, right? I mean, it took us two quarters to install broad and favorable policies. That was our commitment to the patient community. That is fast, guys. I mean, two quarters is really outstanding, an outstanding job done by the team. We will seek to replicate that for CIDP. Thank you.

Operator

Next, we'll take a question from Akash Tewari at Jefferies.

Akash Tewari
Akash Tewari
Global Head of Biopharmaceutical Research at Jefferies

Hey, thanks so much. So kind of on that point, on CIDP, you mentioned in the past you were clearly seeing strong demand from doctors, but you wanted to see how that actually translated to patient and payer demand, given the label, the overlap, and the prescriber base, and the amount of IVIG experienced patients here. Would it be fair to say the CIDP launch should at least be half as good as GMG out to the first year? And maybe to that point, do you think we will see this kind of inflection after two quarters with CIDP like we saw with GMG? I just wanted to double-click on that point, like Beth would say. Thanks so much.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, Akash, and thank you for the question. Thanks for being with us today. It is tempting, right, to draw analogies between an MG launch and a CIDP launch. But what we're trying to say and explain is that two distinctly different markets with their own dynamics, launch dynamics. And maybe, Karen, you want to dig a bit deeper into this question, right?

Karen Massey
COO at Argenx

Yeah, I think that's right. It's very hard to draw parallels. They each have their own dynamics. One thing that I would say around the inflection point that you mentioned after two quarters, I wouldn't think about an inflection point. The payer policies will come in sort of one by one over the two quarters. And what we like to think about is that sort of by the time you get to the end of two quarters, you might have sort of that critical mass where neurologists really can start to get confident that favorable payer policies are in place. So we do believe that there will be uptake, the same as that we saw in MG. And we think that it'll be consistent over the period of time. But the dynamics between the two launches are very different for the reasons that you pointed out.

Operator

We'll go next to Alex Thompson at Stifel.

Alex Thompson
Alex Thompson
Research Managing Director of Biotech Equity Research at Stifel

Hey, great. Thanks for taking my question. I guess I wanted to ask about OPEX trajectory over the next couple of years, how you're thinking about that as it relates to expansion into additional phase III programs, as well as thinking about commercial expansion beyond neurology. Thanks.

Karl Gubitz
CFO at Argenx

Thank you, Alex. I'm Karl Gubitz. I'll take that question. In terms of SG&A, our infrastructure is now largely in place. As you would remember, we put that expansion in the U.S. in Q1. For the rest of the world, we have infrastructure in most of the markets. There's a few big markets still outstanding in Europe. I would expect SG&A from here on forward to grow, but if we grow, we'll be muted, and you won't see that rapid expansion. In terms of R&D, again, I think that will grow quarter-over-quarter as we invest in all the new science, which we talked about last week. I think we have a unique opportunity to invest in ourselves here to set us up for a long, sustainable future. That's what we're going to do. Thank you for the question, Alex.

Operator

We'll move next to Thomas Smith at Leerink Partners.

Thomas Smith
Thomas Smith
Senior Managing Director and Senior Biotechnology Analyst at Leerink Partners

Hey, guys. Good morning. Thanks for taking the questions, and congrats on the strong results. For VYVGART in MG, can you just remind us on the data that's being generated that could support chronic dosing in addition to the current cycle-based dosing? And whether you expect to get chronic dosing explicitly added into the label, or how important do you think it is for prescribers to have that chronic dosing flexibility in the label to facilitate access and reimbursement? Thanks.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, thank you for the question. The answer is simple. We have chronic dosing in the label. The label is basically describing the use of VYVGART for the treatment of acetylcholine receptor antibody-positive gMG patients. So we have cyclical dosing, but that is, of course, chronic use. And we're the only company which has already such a long timeline of chronic dosing of patients. But I think it is important to call out that the safety profile of the drug maintains consistency and that we see a consistent minimum symptom expression over multiple years now in 50%-55% of the patients.

Tim Van Hauwermeiren
CEO at Argenx

What we did do is we ran an ADAPT-NXT study, which was filling a data gap for those patients which, for example, are coming from chronic plasma exchange or chronic IVIG patients, which we really did not study in the ADAPT trial because these patients cannot stand, of course, cyclical dosing. If you're on a weekly plasma exchange, you will need real intense chronic therapy. And with the ADAPT-NXT study, we have actually shown that every other week dosing with VYVGART is as powerful as the cyclical dosing, both from an efficacy and a safety point of view. So in summary, I think we're the only company really with chronic dosing data, and we're the only company which can offer such a diverse set of dosing schedules. Thanks for the question.

Operator

Next, we'll move to Yaron Werber at TD Cowen.

Yaron Werber
Yaron Werber
Managing Director and Senior Biotechnology Analyst at TD Cowen

Great. Thanks so much, and really nice showing, Tim. Quick question. Just in Europe and Japan, I know Europe is very tough these days, and Japan usually got lumpiness, as you noted, and obviously changes in pricing. But just any sense, kind of what should we expect there in terms of acceleration of sales? Thank you.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, even that is a great question, and thank you for zooming out on the global aspirations of the company. This is a question I would like to hand over to Karen.

Karen Massey
COO at Argenx

Yeah, happy to take this, and thanks for the question. Maybe I'll break them out and talk about Europe first and then Japan. I would say in Europe, we're on track. As you know, it takes a little longer, as you already called out, in Europe to get pricing and reimbursement in place across all of the different countries. We're pleased with the progress that we've made. Certainly in three of the big five markets, Germany, Spain, and Italy, we have good reimbursement. We have strong clinical advocacy, and we're really seeing that consistent uptake with what we're seeing in the U.S. What I mean by that is that we see a broader prescriber base, not just in the academic centers, broader potential, and really pushing towards earlier line use. I think we're seeing consistent trends there.

Karen Massey
COO at Argenx

And as we open up new markets with pricing and reimbursement, then I think you'll start to see that consistent growth as well. So we're pleased where we are in Europe. We're on track. We take it step by step. It takes a little bit longer. In Japan, I just want to applaud the team. I think they've done a phenomenal job. I mean, if you look back quarter-over-quarter, it's just so incredibly consistent, the growth in Japan. And we see that again this quarter. I would imagine that you can imagine that outlook being consistent moving forward. So we just recently launched VYVDURA, which is the name for subcutaneous in Japan. And like in other markets, we're seeing that really expand the patient population that is open to VYVGART, with, again, opening up those earlier lines of treatment.

Karen Massey
COO at Argenx

So again, I would say consistent growth, as you've seen for the last 10 quarters from Japan, that we can expect in the future. Thanks for the question.

Operator

We'll move next to Matt Phipps at William Blair.

Matt Phipps
Matt Phipps
Group Head of Biotechnology at William Blair

Thanks for taking my questions. Congrats on all the progress. Quickly, you mentioned a different endpoint in the next ITP trial. Is that just looking at a different timeframe for sustained platelet response, or can you use something like IWG responders as a primary endpoint? And then maybe just quickly on the launch of ITP in Japan, any sense yet on where VYVGART is being used in the treatment paradigm for ITP patients? Is it after multiple thrombopoietin agonists, or can you slot earlier in that treatment paradigm? Thanks.

Tim Van Hauwermeiren
CEO at Argenx

Great question. Thank you, Matt. I will hand over question two to Karen. On the ITP trial, I think the reason why we can go with a significantly smaller study in a confirmatory mindset is, A, because we can work with an endpoint which is looking for extent of disease control, and B, we can really leverage the know-how and the expertise we have developed in running ITP clinical trials. I think this is going to be, roughly speaking, a trial less than half the size of the global phase III trials which we have done so far. We think it's a responsible investment to make for a significant patient and that need waiting on the other line. Karen, would you mind discussing the Japan question, please?

Karen Massey
COO at Argenx

Yeah, happy to take that. I would start by saying the ITP launch in Japan is going really well. We've applied sort of the same launch playbook that we have in other launches, and we're seeing the same strong early performance. What I would say is that it's clear that there's an unmet need in these ITP patients. So far, what we're seeing, to your specific question, is that the early experience is in later lines of therapy, and that's exactly what you would expect in any of these launches. The doctors want to try to get experience, maybe those refractory patients in those later line patients get experience under their belt and then start to move earlier line. But what we're seeing that I'm really pleased with is that there's a strong belief in the MOA, in the mechanism of action of FcRn.

Karen Massey
COO at Argenx

The neurologists, sorry, the hematologists are responding that they believe in the MOA and therefore that they believe in the reason to try VYVGART. So I would say strong early results, exactly where we would expect them, and really important learnings that we're going to be able to take away from this Japan launch as we think about the U.S. and potentially other launches with the second study that we're planning. Thanks for the question.

Operator

We'll go next to Suzanne Van Voorthuizen at Kempen.

Suzanne Van Voorthuizen
Head of Life Sciences Research at Kempen

Hi, Tim. This is Suzanne from Kempen. Thanks for taking my question. I just have a small follow-up to last week's R&D day regarding ARGX-121, the IgA degrader that was revealed. Can you give some context to the indications where such a molecule would fit well, how many indications you see, and also how you compare the opportunity in terms of size? Is there potential for this to be an opportunity of VYVGART size, or do you see more parallels to a drug like Empasiprubart when looking at, yeah, the commercial opportunity? Any thoughts or direction here would be appreciated. Thanks.

Tim Van Hauwermeiren
CEO at Argenx

Thanks, Suzanne. Thank you for this question. You know that when we take a product forward in the pipeline, that it has got the right to play across multiple indications. So it's not a single indication asset. I think what we said on the podium during the R&D day is that there's a growing understanding of the pathogenic role IgA autoantibodies play in autoimmune disease. It's actually remarkable how little we know above and beyond pathogenic IgG. So this is a field which is completely emerging. We're very pleased that we can go in there and pioneer. That's the work we like to do. And then in terms of indications, we give you a conceptual list of indications where we know that IgA autoantibodies drive disease. Of course, everyone knows about IgA Nephropathy. I think that is a field which is just being built.

Tim Van Hauwermeiren
CEO at Argenx

I think it's a large market opportunity which will support multiple generations of innovation and multiple innovative molecules. So that's an obvious one. We spoke about IgA Vasculitis, where again, from a biology point of view, that is in the bullseye of the disease. There are more indications. At this moment, we will stay conceptual because we're still doing some background work on these indications. The opportunity will unfold when we bring this molecule online in all these different clinical trials. So stay tuned. We think it's a significant opportunity where I think we can follow the biology. So we're very excited about the molecule. Thank you.

Operator

We'll go next to Yatin Suneja at Guggenheim Partners.

Yatin Suneja
Senior Managing Director and Biotechnology Analyst at Guggenheim Partners

Hey, guys. Congrats on the quarter. Two very quick ones for me. Could you just talk a little bit more about the subQ and IV dynamic, like how is subQ, what sort of share subQ has right now versus IVs that's sort of growing the market? And then just as we think about the future with the launch of CIDP, any thoughts on establishing guidance for us? Thank you.

Tim Van Hauwermeiren
CEO at Argenx

Thank you for both questions, Yatin. Let's start with question one, the subQ versus IV dynamic. Karen, would you mind commenting on the dynamic? I don't think we quantify it, right? But maybe you can explain the dynamic.

Karen Massey
COO at Argenx

Yeah, happy to. Exactly. So we don't provide the specific breakdown, but what I would say that I think is helpful in terms of the dynamic, both VYVGART and VYVGART Hytrulo are growing in terms of new patient starts and in terms of revenue. And what we see and what the real value of VYVGART Hytrulo is, is that I would say it opens really up new prescribers that might not be, for whatever reason, interested or comfortable with an IV option. So new neurologists that are more comfortable with injections. And that also opens up new patients that are seeing those neurologists, or potentially there are patients that don't want to go have the IV. Maybe they think that their disease is not severe enough that they need an IV option, but they're open to an injection option.

Karen Massey
COO at Argenx

So I would say by having subcutaneous, it aligns directly with our strategy of moving into early line treatment, and we see that very clearly. And it also aligns with our strategy of broadening the prescriber base for VYVGART, which obviously also helps us with CIDP. The other important dynamic that I think I just want to highlight on VYVGART Hytrulo is that our goal and our strategy is not a switch strategy from VYVGART. So around 60% of the VYVGART Hytrulo patients that are starting on VYVGART Hytrulo are actually new to the VYVGART franchise. And that just demonstrates how we're really expanding the market, both in terms of prescribers and patients with the subcutaneous option. And I'll hand it back to you, Tim.

Beth DelGiacco
Head of Investor Relations at Argenx

Actually, we had a cut in our line. If Yatin is still on, if he could just repeat his second question, that would be helpful.

Yatin Suneja
Senior Managing Director and Biotechnology Analyst at Guggenheim Partners

Yeah, I'm online. So the second question was about guidance. How are you guys thinking about establishing guidance, and when should we expect that?

Tim Van Hauwermeiren
CEO at Argenx

Okay, that is clear. Thank you, Yatin, for repeating it. This is a question for Karl, right?

Karl Gubitz
CFO at Argenx

Yeah, thank you. Thank you, Yatin. I mean, we didn't provide guidance this year, revenue guidance, due to all the unknowns out there, in particular for CIDP launch and the geographical expansion. So I think as a company mature, clearly we need to think about guidance. So we will listen to our stakeholders, including our investors and analysts, and this is something which we will consider. Maybe this is something we can do in January next year. But for now, we're going to focus on executing, and we have provided the expense guidance and the cash guidance, and I will leave it at that for now.

Operator

We'll go next to Vikram Purohit at Morgan Stanley.

Vikram Purohit
Vikram Purohit
Executive Director of Biopharma Equity Research at Morgan Stanley

Hi, good morning. Thank you for taking our question. We had one on the commercial opportunity in Ocular MG. So based on the neurologist feedback you've received and just the experience you have in the space with this indication overall at this point, how distinctly do you think Ocular MG is managed and viewed and treated versus more generalized MG? And based on that, how drastically do you think the cadence of patient adds could change based on a potential label expansion into Ocular MG? Thanks.

Tim Van Hauwermeiren
CEO at Argenx

Thanks for the question on ocular MG. So by having been now in the MG space for some time, we have been hearing more about unmet medical needs in ocular MG, and it could be a wrong assumption that ocular MG is a milder form of MG compared to the generalized form of myasthenia. So ocular MG patients are pretty debilitated and disabled because with double vision, there's not too much activities of daily living you can do in terms of working on screens, driving, and then I'm not even talking about the headaches these people experience. Today, ocular MG patients are basically only treated with steroids, and some of them actually do very well on steroids, but there's a subset of ocular MG patients which badly need another tool in the toolbox.

Tim Van Hauwermeiren
CEO at Argenx

After close consultation with the community and the experts, we could crystallize, I think, a pretty elegant Ocular MG study. We had a successful interaction with the FDA agreeing on trial design and endpoint. In the real world, some of these Ocular MG patients are actually seen by ophthalmologists or neuro-ophthalmologists, and then when these symptoms start to spread, they're being referred to a neuromuscular specialist. I think this is a significant opportunity and a nice addition if we are successful to our presence in the MG space. Thanks for the question.

Operator

We'll take our next question from Charles Pitman-King at Barclays.

Charles Pitman-King
Charles Pitman-King
VP of European Pharmaceuticals Equity Research at Barclays

Hi, thank you very much for taking my questions. Two from me. Just coming back to the potential risks from competitor readouts to your kind of dominant position in the second half of this year, I'm just wondering what metrics will you be looking at from these readouts to determine whether any of these really pose a risk to your increasing market dominance? And then just the second one on the kind of Chinese commercial opportunity. I mean, I understand Zai Lab's not going to be reporting on the 7th of August, but just in terms of how you are thinking about this from an argenx perspective, how established are the treatments, and what is the expected addressable market and pricing structure, the expected benefit from going forward? Thanks.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, thank you for both questions. Karen, I will give the second question to you. I think on the first question, we can be relatively brief. In absence of data, I think we would find ourselves in an area of speculation, which we do not really like to do as a science-based company. The only thing I can do is remind you of how high we have set the bar in the MG space. I think we have the fastest onset of action. We have the deepest action. We have a very nice durability now over many, many years in our MG patients. And importantly, I think we have a very clean safety profile. And then from a product presentation point of view, I think we have by far the broadest portfolio of product presentations, which we will continue to aggressively expand.

Tim Van Hauwermeiren
CEO at Argenx

That's fate for the data, but I think we're well equipped to compete. Karen, do you mind taking on question two?

Karen Massey
COO at Argenx

No, happy to take that question, Tim. And look, I won't comment on Q2 results. Of course, we'll let Zai Lab comment on that. But what I will say is a few thoughts on, first of all, starting with the fact that I think Zai Lab are incredible partners, and they've done a great job with the launch of MG. And we see, and with them, a long-term partnership, and I think a lot of opportunity in the future in China. Obviously, it's a big market, and what we've seen to date is a lot of volume coming in early on. Through Q1, you saw a big volume of new patient starts in Q1. And I think that reflects the market opportunity in China. I think we've done a great job of not just getting the approvals, but also the NRDL listing, and that has certainly helped with uptake.

Karen Massey
COO at Argenx

We expect that to continue. More recently, we got the subcutaneous version approved in China. I think overall, between the volume of patients with MG in China, alongside the great partner we have in Zai Lab, I think we're looking positively at the outlook for China. I'll hand back to you, Tim.

Tim Van Hauwermeiren
CEO at Argenx

Thanks, Karen. Thanks for the question.

Operator

We'll go next to Leland Gershell at Oppenheimer.

Leland Gershell
Leland Gershell
Managing Director and Senior Biotechnology Analyst at Oppenheimer

Great. Thanks for taking our questions. Just wanted to ask, Karen, you've been consistent in moderating expectations for securing payer agreements for CIDP. Just wanted to ask if that process has been going in line with your expectations internally. And also wanted to ask if you've been facing any pushback from payers with respect to requiring a step-through from IVIG. Thank you.

Tim Van Hauwermeiren
CEO at Argenx

I think this is an excellent question.

Karen Massey
COO at Argenx

Yeah, happy to take that.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, thank you.

Karen Massey
COO at Argenx

Yeah, sounds great. It's a great question. We talked earlier about why it's so important to get these payer policies in place. I would say that we're, as I've said before, we're exactly on track with where we thought we would be. I mean that in terms of both how the conversations with payers are progressing, which are progressing well, and also the conversations that we're having with payers in terms of what those policies should look like. In terms of IVIG, I think one thing that's important to remember about the CIDP market is that the majority of patients have been exposed to IVIG at some point. We know from our clinical trial that we have equal right to respond, whether it's IVIG as background therapy coming off no treatment in the last six months or steroids.

Karen Massey
COO at Argenx

So we think we're well positioned with our data, and we think the payer discussions are going well to get policies in place that will set us up for a successful and a strong launch over the coming quarters. Anything to add, Tim?

Tim Van Hauwermeiren
CEO at Argenx

Thank you for the question. We're ready for the next one.

Operator

We'll go next to Samantha Semenkow at Citi.

Samantha Semenkow
Samantha Semenkow
VP and SMid Biotech Equity Research Analyst at Citi

Hi, good morning, and thanks for taking the question. Just one on the PFS for me. Now that you filed and you're preparing for a potential launch of the PFS, I'm curious how much more growth in GMG are you really thinking about that that formulation will drive? What patient segments do you expect to open or expand? Do you think this will be more of a switch market than what you've seen with Hytrulo? And just how should we think about the magnitude of impact on revenue, assuming you have that approval in the near future? Thank you.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, thank you. That's a great question on PFS. And Karen, I think why don't you explain why this will just continue that steady, strong trajectory into the MG population, please?

Karen Massey
COO at Argenx

Yes, I think that's exactly it, Tim, and what I was going to say. I would say this just continues to expand and reinforce the momentum as we continue. We started with IV, then we expanded into subcutaneous, and then certainly expanding into PFS. It opens up different prescribers as well as different patients. And I think that's reflected in terms of how we explain the addressable market expansion at R&D day. Certainly, what we see is that there will be a growth in biologic share of market and that we will be well positioned within that growth. And certainly, PFS helps us to maintain our leadership and certainly with the early aligned patients and the broader prescriber base, given the fact that we will have IV and PFS.

Karen Massey
COO at Argenx

I would think about it as continuing to maintain our momentum and continuing in line with our strategy of early align and broader prescriber base. Thanks for the question.

Operator

We'll go next to Joon Lee at Truist Securities.

Joon Lee
Joon Lee
Managing Director and Senior Biotech Analyst at Truist Securities

Hey, thanks for the updates and for taking our questions. For the no-go decision on myositis by year-end, are they all coming at once or one by one? And if efgartigimod works in one but not in the other myositis subtypes, what would be some of the reasons for that? And what are you looking forward to learning from that to further enhance the choice of your future indications and maybe even reprioritize your existing pipeline indications? Thank you.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, thank you, Joon Lee for the question, and thanks for being with us. So in this basket trial where we combined three subtypes of myositis, the go/no-go decision point will all come at the same time. So we're synchronizing the first 30 patients across the three indications to make one decision. And remember that this is an operationally seamless phase II, phase III trial. So while these data are maturing, we are actually already entering into the phase III portion of the trial at risk. So technically speaking, the only decision we can make is a stop decision. And of course, the first 30 patients will be informative, so it will allow us to make stop decisions in one, two, or three of these indications, but it will also allow us to adjust sample size. Look, all three indications come out of the same organics mold.

Tim Van Hauwermeiren
CEO at Argenx

I mean, strong conviction in biology, I think a responsible, thoughtful clinical trial design, but not completely risk-free. So I think we did everything we could to design it and risk mitigate it. So I don't think there is any specific read-through of a myositis outcome onto any other indication which we have loaded into the pipeline because they all follow the same blueprint. Thanks for the question.

Operator

We'll go next to Gavin Clark-Gartner at Evercore ISI.

Gavin Clark-Gartner
Gavin Clark-Gartner
Managing Director of Biotechnology Equity Research at Evercore ISI

Hey, thanks for taking the question. Quick one on thyroid eye disease. Just wanted to confirm you're doing weekly dosing in the phase IIIs and also just ask how enrollment is going now that you're about four months in? Thanks.

Tim Van Hauwermeiren
CEO at Argenx

Thanks for the question on TED. You're right that we're in weekly dosing. We're doing that with the prefilled syringe already. I think we're in a classical, typical trial execution mode. Stay tuned on how the study is doing. We will keep you updated over the coming quarters. We feel very strong about the opportunity and the traction we're getting with this global clinical trial. Thank you.

Operator

Next, we'll go to Andy Chen at Wolfe Research.

Andy Chen
Andy Chen
Director and Senior Analyst of Equity Research at Wolfe Research

Good morning. Thank you for taking the question. So I heard this $450,000 pricing. I'm just curious if you can talk about how robustly this pricing can stay at $450,000 because as you have payer contracts, there's a natural pressure for ASP erosion. So just curious if you can comment on the dynamics here. Do you see room for this number to go up over time in the next few years, or do you think this is going to stay the same at $450,000, or do you think this is going to go down? Thank you.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, so Andy, thank you for the question, which I'm happy to take. So let me first briefly comment on the $450 numbers. That number, of course, did not come out of the blue sky. I think it is the result of a thorough understanding of, I think, the value proposition which we have to offer. Careful calibration, of course, with payers where we socialize the phase III data with them. And the data actually which resonates very well with payers is the regain of function data Karen was already alluding to. And especially, I think the fact that the majority of the people who entered the trial wheelchair-bound were able to leave the trial outside of the wheelchair. So these are pretty meaningful data which represent significant value. We're now finalizing the payer agreements, so stay tuned. We also discussed that during the call.

Tim Van Hauwermeiren
CEO at Argenx

Look, I cannot predict the future. I think it is fair to assume that with more competition and more indications, there may be some pressure on your price. But I think as a company, we're pricing transparently and responsibly, and I think we're very well equipped with our market access strategies to go into our future. Thank you for the question.

Operator

Next, we'll move to Joel Beatty at Baird.

Joel Beatty
Joel Beatty
Biotechnology Equity Research Analyst at Baird

Thanks, and congrats on the strong growth from Q1. Looking back, what led to the weaker Q1, and how much of that was seasonal in nature and would be expected to repeat versus any dynamics that might have been one-time in nature?

Tim Van Hauwermeiren
CEO at Argenx

Yep, thank you for asking the question. I think we alluded to that in the prepared remarks, but maybe Karen, do you want to comment when we look through the optics of Q1 and Q2, what the real underlying strength of the business is?

Karen Massey
COO at Argenx

Yeah, absolutely. When we look at the business, what we look at is those underlying drivers of growth. So are we adding new patients consistently? Are we moving earlier line? Are we broadening our prescriber base? And we see those pretty consistently through Q1 and Q2. I would say those Q1 dynamics that you see across the industry, not just with VYVGART, around re-verifications, weather, I'd say they're always going to be there. Whether they were worse in Q1 because the weather was worse in some parts of the U.S. or whatever you may have, I mean, I think we can all look back at that. But those Q1 dynamics are more, I would say, across the industry. The VYVGART performance and the KPIs, I would say, is pretty consistent throughout actually the 10 quarters of growth that we've had, and we would expect that to continue.

Karen Massey
COO at Argenx

Thanks for the question.

Operator

We'll take our final question from Douglas Tsao at H.C. Wainwright & Co.

Douglas Tsao
Douglas Tsao
Managing Director at H.C. Wainwright & Co

Hi, good morning, and thanks for taking the questions. Just a quick follow-up on ITP. I understand you think you have, from a regulatory standpoint, an efficient way to move forward. I'm just curious what feedback you may have gotten from KOLs as well as how you're thinking about the commercial positioning, just given the finding from the prior phase III study in terms of the effect of low-dose steroids. Thank you.

Tim Van Hauwermeiren
CEO at Argenx

I'm not sure we understood the question completely because the line was breaking up. Would you mind briefly recapping the question, please?

Douglas Tsao
Douglas Tsao
Managing Director at H.C. Wainwright & Co

Yeah, sorry. Can you hear me now, Tim?

Tim Van Hauwermeiren
CEO at Argenx

Yeah, we can.

Douglas Tsao
Douglas Tsao
Managing Director at H.C. Wainwright & Co

Okay. So I was just asking, so I understand you believe in ITP that you have an efficient path forward from a regulatory standpoint. I'm just curious in terms of how you're thinking about the product's positioning, if it has changed prior to the prior phase III results, and what feedback you may have gotten from KOLs, especially in terms of the efficacy or the apparent efficacy of low-dose steroids. Thank you.

Tim Van Hauwermeiren
CEO at Argenx

Yeah, we got it. So there is quite some excitement in the community about the data which we generated in the clinical trial. In this refractory patient population which we are targeting and in which we will be positioning third line, right, after steroids and TPOs, in that patient population, not much is really working, and we showed a very high response rate and an unprecedented safety profile. And that is really important for the KOLs. They also continued to call us about how well their patients were doing in the study, the ongoing open label extension. So there was quite some pull from the marketplace, I would say, for this product. And I think they were also very collaborative in helping us to think through the proposal we would make vis-à-vis the FDA. So positioning has not changed.

Tim Van Hauwermeiren
CEO at Argenx

KOL feedback is very positive, and that strengthens our determination to go forward. Thanks for the question.

Operator

This concludes today's question and answer session and today's conference call. Thank you for your participation. You may now disconnect.

Analysts
    • Akash Tewari
      Global Head of Biopharmaceutical Research at Jefferies
    • Alex Thompson
      Research Managing Director of Biotech Equity Research at Stifel
    • Allison Bratzel
      Equity Research Analyst at Piper Sandler
    • Andy Chen
      Director and Senior Analyst of Equity Research at Wolfe Research
    • Beth DelGiacco
      Head of Investor Relations at Argenx
    • Charles Pitman-King
      VP of European Pharmaceuticals Equity Research at Barclays
    • Derek Archila
      Managing Director, Co-Head of Therapeutics Research, and Senior Biotechnology Analyst at Wells Fargo
    • Douglas Tsao
      Managing Director at H.C. Wainwright & Co
    • Gavin Clark-Gartner
      Managing Director of Biotechnology Equity Research at Evercore ISI
    • James Gordon
      Executive Director of European Pharma Equity Research at JPMorgan
    • Joel Beatty
      Biotechnology Equity Research Analyst at Baird
    • Joon Lee
      Managing Director and Senior Biotech Analyst at Truist Securities
    • Karen Massey
      COO at Argenx
    • Karl Gubitz
      CFO at Argenx
    • Leland Gershell
      Managing Director and Senior Biotechnology Analyst at Oppenheimer
    • Matt Phipps
      Group Head of Biotechnology at William Blair
    • Rajan Sharma
      Executive Director of Pharma & Biotech Equity Research at Goldman Sachs
    • Samantha Semenkow
      VP and SMid Biotech Equity Research Analyst at Citi
    • Suzanne Van Voorthuizen
      Head of Life Sciences Research at Kempen
    • Tazeen Ahmad
      Senior Equity Research Analyst at Bank of America
    • Thomas Smith
      Senior Managing Director and Senior Biotechnology Analyst at Leerink Partners
    • Tim Van Hauwermeiren
      CEO at Argenx
    • Vikram Purohit
      Executive Director of Biopharma Equity Research at Morgan Stanley
    • Yaron Werber
      Managing Director and Senior Biotechnology Analyst at TD Cowen
    • Yatin Suneja
      Senior Managing Director and Biotechnology Analyst at Guggenheim Partners
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