argenx SE (ARGX) Earnings Call Transcript & Summary

Good morning. My name is Rob, and I will be your conference operator today. I would like to welcome everyone to the call. [Operator Instructions] I'd like to introduce Beth DelGiacco, Vice President of Corporate Communications and Investor Relations. You may now begin your conference.

Thanks, Rob. We're very excited to be here today to discuss the FDA approval of VYVGART Hytrulo, our subcutaneous injection for the treatment of generalized myasthenia gravis. The press release can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on Slide 2 that forward-looking statements may be presented during this call. These may include statements about our future expectations, clinical development, regulatory time lines, the potential success of our product candidates, financial projections and upcoming milestones. Actual results may differ materially from those indicated by these statements. Argenx is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Hauwermeiren, Chief Executive Officer; and Karen Massey, our Chief Operating Officer. Karl Gubitz, Chief Financial Officer; and Luc Truyen, Chief Medical Officer, will be available for the question-and-answer portion. I'll now turn the call to Tim.

Thank you, Beth, and welcome, everyone. Slide 3. I'm very excited to be here today to share that the subcutaneous efgartigimod, branded as VYVGART Hytrulo, was approved by the FDA for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive. This approval marks the second innovation we are bringing to the gMG community just 18 months after receiving FDA approval for VYVGART, our first-in-class innovation. The feedback from our launch so far has been incredibly rewarding, and we are hearing from patients and physicians that we are offering a new treatment standard for gMG. Patients can gain a significant efficacy benefit without having to compromise on safety and tolerability. This is transformative. And now with VYVGART Hytrulo, we can offer a consistent benefit within the power of a 30- to 90-second subcutaneous push, creating flexibility on how and where patients can receive treatment. Three points I would like to make before getting into the details of the approval. First, I continue to be impressed by the hard work and dedication of our commercial and medical teams who have built incredible launch momentum. We have reached thousands of patients and both a breadth and depth of prescribers in the first 18 months of launch. We believe that based on the VYVGART Hytrulo label, we will be able to maintain the current loss trajectory as we work to move into earlier patient lines. Second, with this approval, we continue to honor our long-term commitment to the gMG patient community, meeting patients where they are, with a broad individualized treatment offering. Our decision to bring a subcutaneous product combination to market so soon after IV was never a life cycle management decision; it was a strategy driven by the value we place on patient choice so that we can provide the flexibility of IV or subcutaneous administration. And last, I want to bring up innovation. When we first explored the partnership with Halozyme, we were still several years from a commercial launch, but our team had the foresight to find a way to easily deliver a biologic in subcutaneous injection and to put our exclusive agreement in place. This proved to be a fortuitous decision and now we are bringing together 2 great innovations in 1 bottle with the first FDA-approved subcutaneous injectable for gMG. Slide 4. We often get asked about the factors that drove the success of the launch so far, and the biggest is a significant unmet need that exists for gMG. 61% of patients report poor well-being, even though they are taking more than 2 therapies on average to treat their disease. Current long-time treatments can cause significant side effects, creating a scenario in which patients need to make a choice between enduring often debilitating symptoms or experiencing negative side effects. The unpredictable nature of the disease starts early with a difficult diagnosis journey and can ultimately contribute to emotional burden, including depression or anxiety. The impact on society is also felt. More than 1/2 of patients have to stop working and 1/3 required a caretaker to help with daily activities. Slide 5. The ultimate goal for patients is to live without a constant reminder of their disease and its impact on their quality of life. This is what we want to achieve in redefining what well controlled means. It's no longer that you are controlled if you're out of the hospital. We want patients to be able to achieve effective symptom control and to regain control of their lives. With VYVGART Hytrulo, we believe we're one step closer to this, with the flexibility to receive treatment outside of an infusion setting. This gives patients time to do the activities they love. Slide 6. This approval was based on innovative patient-centric bridging strategy. We wanted to bring a subcutaneous option to patients as quickly as possible, and this trial design enabled that. Most bridging studies are based on PK, but ours was based on PD, specifically autoantibody reduction, which in the ADAPT trial was established to correlate to efficacy. You can see the consistency across IV and subcu in both IgD reduction and correlating efficacy measures. Slide 7. These are the highlights of our VYVGART Hytrulo label, which closely mirror the label for IV based on the bridging strategy we used. This is a strong label with its safety profile, [ replicable ] the gMG treatment paradigm and the built-in flexibility for physicians to manage timing of treatment cycles, depending on the patient's clinical response. As part of our long-standing commitment to the gMG community, we will continue to work towards inclusion of self-administration and seronegative patients into the label to make VYVGART to go-to choice for an even broader population of gMG patients, which is a perfect segue to Karen, who will talk more about this.

Thanks, Tim. Slide 8. VYVGART is transformative for MG because of how it simplifies the treatment in a process that I like to call democratizing the treatment of MG. The diagnosis and treatment of gMG and many other autoimmune diseases have been really complex. There are a battery of tests to start treatment, often vaccine requirements. Power treatment options come with safety and tolerability challenges or are not convenient for patients prescribed [ as adult payers ]. The impact, for example, of high-dose steroids on patient lives is very well documented. It takes close management from a gMG specialist to get the right balance between symptom control and side effects. This is why patients are often referred to specialist centers for diseases like generalized MG. For community neurologists, like with anything, the less you do something, the less familiar you are with it and the less practiced you become. Slide 9. Now with both VYVGART and VYVGART Hytrulo approved, we believe that we can further simplify the treatment of gMG deeper into the community and in the process, transform outcomes for patients redefining what well-controlled means. We can build the confidence of neurologists to prescribe VYVGART and the demonstrated efficacy of its 78% response rate after 2 cycles in the ADAPT study. There is a predictability with the safety and tolerability profile, now with real world experience. There are no vaccine requirements and through our PSP and payer policies, we've been able to achieve forward access. And now patients are provided with flexibility and choice, not only in how they want to be treated with IV or subcu, but also where they want to be treated, whether in an infusion center, in a physician's office, or at home with nurse administration. Tim mentioned earlier that we continue to invest in the how patients want to be treated. The current vial and syringe presentation of VYVGART Hytrulo is our first-generation subcu injectable and our prefilled syringe development is already underway. We are also looking ahead at other device options. This [Audio Gap] higher treatment dynamic. Patients have the choice to significantly cut down on treatment time if they prefer and can spend more time doing the things they love. With prescribers, we think we can reach more of them and offer a simple, effective treatment for a very complex disease. Slide 10. We also worked to achieve simplicity of access with VYVGART Hytrulo, building on the successful strategy we deployed with the VYVGART launch. We engaged early with payers for the IV launch, focusing on the significant value VYVGART can bring to patients with its efficacy and safety. This strategy has led us to very broad access, including more than 90% of lives covered with 80% of those policies considered as favorable. With VYVGART Hytrulo, we hope to achieve the same. And we want to make sure that patients, physicians and payers are choosing between IV and subcuts only based on preference and not on price. For this reason, we are taking a parity pricing approach so that the annual net price is consistent across IV and subcu. We will be using -- Slide 11. We'll be using the same patient support program for VYVGART Hytrulo as we did for the IV launch. My VYVGART Path will be available to provide patients with personalized support as they navigate their treatment journey and the insurance process. Through this program, patients are matched with a nurse case manager who can help identify the appropriate site of care for treatment, whether in an infusion center, a doctor's office, or through home administration. Slide 12. Lastly, before I turn the call back to Tim, I want to share the global view for our VYVGART launches, both with IV and subcu. Our VYVGART IV product is now approved in the U.S., in Japan, in Europe, U.K. and Israel, and we're expecting approval in Canada and China by the end [ of 2023 ]. This is the first approval for VYVGART Hytrulo, but we have already filed the subcut in Japan and Europe and expect both approvals by the first quarter of 2024. Having joined argenx just over 3 months ago, I continue to be amazed at the ability of this team and this company to innovate and to execute. Bringing subcut to market just 18 months after the IV and now preparing parallel global launches is impressive and something you see very rarely. I'm proud to have joined a company that truly puts patients at the center in all they do. Tim?

Thank you, Karen. We have really appreciated your contributions during your first 3 months as we think about scaling our commercial infrastructure to prepare for many launches in the future. You can see on Slide 13 that gMG is the very beginning of our journey to transform autoimmunity. We have demonstrated proof of concept now in 4 indications and are awaiting data readouts this year in CIDP, ITP, pemphigus and POTS, all of this working towards our 13 current indications and the plan to be in 15 by 2025. And this is only for our first pipeline candidate. Slide 14. We also announced news this morning from empasiprubart, our first-in-class anti-C2 antibody, and our second pipeline candidate. We had a planned review by an independent data monitoring committee after 9 patients completed the full 16-week treatment period of the first cohort. We observed a favorable safety profile in the first-dose cohort as well as early efficacy signals, both of which support proof of concept of empa in MMN and continuation of the study. All 9 of these patients have rolled over to the ARDA plus open-label extension study. This interim look at empa data in MMN is a meaningful snapshot for us for many reasons. First, empa is a perfect example of our immunology innovation program where we worked alongside Professor Erik Hack from University of Utrecht, to build a differentiated molecule driving an upstream component of the complement cascade. These results provide further proof that our unique approach of co-creation works well. We have a strong track record of creating innovative molecules, which have shown success in the clinics. Adding empa brings us to 8 in total. This has also been a program where we have been able to unravel [ novel ] biology insights on MMN and the role complement activation plays in driving disease. It is gratifying to see a strong signal for empa in its first indication because it provides further support for the body of translation work we have generated. With a very possible decision to target C2 based on solid translation biology, together with [indiscernible] antibody engineering, we hope to be able to bring a new therapy to MMN patients who continue to face significant unmet needs. We feel confident that empa can be another pipeline in the product assets and that continued investment in our IIP will help to drive organic value from our pipeline including at least 1 additional pipeline candidate, which will be nominated by year-end. Slide 15. Today is a very exciting day for argenx as we continue to demonstrate our ability to execute across the value chain from discovery work to commercial strategy. This includes: the unique biology insights we generate; the successful outcomes of our R&D work; another win on the regulatory front based on an innovative trial design; and delivering on our commitment to transform how autoimmune disease is treated, bringing patients one step closer to living the life they want. Thank you all for the time today and your continued support. We will now open the call for your questions.

[Operator Instructions] And your first question comes from the line of Tazeen Ahmad from Bank of America.

I have a few, just for clarification purposes. So Tim, just with this approval, when do you think you would actually have the subcu available in the U.S.? And do you think that with the availability of the subcu, that the pace of the launch will accelerate in the second half of the year? That's my first question. And then secondly, with the label for acetycholine receptor positive patients only, what proportion of the MG community now would you not have access to? And what plans would you have in order to, over time, gain access to the receptor negative patients as well?

Thank you, Tazeen, for these questions. I will hand the commercial questions in a second to Karen on when the product will be available and whether this will accelerate the launch. Let me first take on your question on the acetylcholine receptor antibody negative patients, which is a very important one for us. We have made a long-term commitment to the gMG community, and we're not going to give up all the negative patients. You know that we have compelling evidence from other parities on the efficacy and safety of the drug and we have our plan ready. So this was step 1 in our plan. Now that we don't have it in this current label, we will refer to the second step in our strategy, and we will communicate about it later this year. Karen, would you mind taking on the first 2 questions, please?

Yes. Thanks, Tim, and thanks for the question. So on the initial question of when it will be available, we expect it to be available in July. Similar to the IV launch, the team has been working hard to ensure quite quick access in the channel. In terms of the second question around whether we expect this to accelerate the launch momentum, I wouldn't think about acceleration. What I would think about is that since the launch of IV we've got, what we've seen is continued momentum and continued growth quarter-over-quarter. And we're now approaching 18 months after launch. What you could normally expect is that that growth might slow. But I believe that we will see not an acceleration, but indeed, a continued momentum in terms of how we're delivering VYVGART and now also with VYVGART Hytrulo. What we've seen in market research and in conversations with patients and with prescribers is that there's not a bolus of patients that are being held back and not started on VYVGART because they're waiting for subcutaneous, so we don't believe there'll be a bolus. But we do believe that this provides an additional and an important option for a difference in how patients can be treated and therefore, we'll continue that steady momentum that we've seen.

Okay. Got it, Karen. And so should we assume that at least initially, most of the pickup for Hytrulo will be switches from IV? Or do you think that the new patient starts will also drive it?

Yes. Great question. We believe that it will be both. We are not pursuing a switch strategy. There may be some patients' prescribers who do prefer the subcutaneous option. But -- and we also believe that there will be some new patients that come on board. The one thing that I would just note that I should have noted earlier is don't forget there could be new-to-market blocks depending on individual payers through the second half of the year on the subcutaneous VYVGART, depending on when they decide to review their policy. So that could have an impact as well.

And your next question comes from the line of Derek Archila from Wells Fargo.

Congrats on the Hytrulo approval. Just 2 questions from us. Just first, wanted to know since Hytrulo was approved as an HCP-administered product, does it remain Part B or does that change? And then also just on the self-administered prefilled syringe and development, just maybe an update on the status there? And is that different from the high concentration formulation you've talked about in the past?

Thanks for the question. We have the benefit of having Luc with us, our Chief Medical Officer. Luc, would you mind addressing the question on HCP administration first, please?

Yes. Thank you for the question. With getting that discussion with the agency, the 2 main factors that were considered were the actual nature of the presentation with a [ butterfly ] and a vial. And the second, then how would that interact with the actual disease condition. In other words, double sites, waxing-waning strength. And in that discussion, it was felt that bringing their HCP in as the sole source of administration was probably the better choice. We have to remember that this was actually a formulation that was designed to bring the ability for the subcutaneous to patients as quick as we could and address that unmet need. And I think having that HCP administration actually provides us an opportunity to learn more about these conditions under which self-administration could occur, which would inform our prefilled syringe development.

And then to your second question, Derek. So we're working diligently towards the PFS, the prefilled syringe, which is the next generation. The high concentration, we're already at high concentration, by the way. It's quite remarkable. You can concentrate the bottles equal to the concentration of [ VNF ] up to 200-milligram per milliliter, typically no penalty on viscosity like a full-size molecule antibody. We are working above and beyond this formulation also with [ electrify ] on a very high concentrated formulation. That collaboration is progressing well and I would say, stay tuned for further information in the coming periods. Thank you for the question.

Your next question comes from the line of Rajan Sharma from Goldman Sachs.

Just to follow up on the seronegative population and just if you could clarify that. Is the base case that you'd need to do an additional trial in that setting to get an approval? And then secondly, just in terms of -- to the extent that you've had any discussions with payers on the subcutaneous coverage to date. Can you share any feedback from that? And I guess how fast do you expect to get to the IV level of coverage?

Thank you, Rajan, for the question. I will hand over the question on payers to Karl in a minute. But maybe first, Luc, your comment on seronegatives, please?

Yes. So doing another trial is certainly not our first option that we would go for. As was already indicated, we have accumulated, both in the real-world setting, but also in the 2001 trial itself, additional data on how efgartigimod can provide efficacy to seronegatives. And we will reach out to the agency to set up a meeting to discuss these data. And then in that discussion, hear what else could be needed. If there -- from there, the option comes for an additional trial, we will evaluate that and look at what that could mean.

Karl?

Thank you, Rajan. Yes, we think that the discussions are ongoing with the payers. It will take time. You will see similar dynamics as with the IV. So think about it as 1 quarter or 2, also taking into account the new market blocks. But we are confident that we will get equal coverage and broad coverage over time.

And your next question comes from the line of Yatin Suneja from Guggenheim Partners.

Two quick ones for me. First one is on 117. Could you characterize the signal that you saw in the efficacy assessment? I think in the PR, you mentioned that it was based on 22 patients, but only 9 completed the full 16-week treatment. So I'm curious to understand how quickly you're seeing the signal, what exactly, if you can articulate for us in terms of the signal that you're seeing. And then the question on the subcu. I mean in terms of the adoption, do you think the patients who are already on IV are the first switchers, like they'll switch to subcu? Are there any restrictions or a particular requirement if somebody wants to switch from an IV to a subcu? And congrats on getting this approved.

Thank you, Yatin. Thanks for joining us today. I will hand over the IV subcu question to Karen in a second, but maybe, Luc, you want to give some further color to where we are with 117?

Yes. First of all, this is quite exciting. This is the first time that we get a new intervention showing promise in MMN, where there was a lack of innovation. I will have to carefully answer your question because this is still a blinded trial, which ultimately, will become part of a regulatory submission, so I cannot provide too much detail. With respect to the data quantity we looked at, per protocol, once 9 patients had achieved 16 weeks, we have a data cut made that was sent to an independent data monitoring committee as well as an internal panel. From that, we learned that safety would not be an issue to proceed with the next cohort. And the internal panel evaluated that across several measures, there was a consistent response that would allow us to proceed to the selection of the dose. And I'm afraid I have to keep it at that. But just to say, the consistent response gave us sufficient confidence that we could make that step.

Thanks, Luc. And, Karen, do you want to comment on the second question?

Yes, sure. Thanks, Tim. So as I mentioned earlier, we're not pursuing a switch strategy for IV to subcutaneous, and that might be different from some of the strategies that other companies pursue when they launch a subcutaneous. This is not a life cycle management strategy for us. We're trying to put patients at the center, meet them where they are and ensure that they have options for how they receive their treatment. So that's not our strategy. Having said that, there's no restriction in the label; patients can switch from IV to subcutaneous. And what we'll be pursuing is a strategy where the patients, the provider should have a conversation and have a shared decision based also on the patient's access, the patient's preferences, as well as the prescriber's decision on whether they should be either started or switched to subcutaneous.

[Operator Instructions] Your next question comes from the line of Samantha Semenkow from Citi.

Let me add my congratulations on the approval. I was hoping to follow up on a previous question on payer dynamics. Is there any potential for acceleration of achieving payer coverage given the payers are already familiar with VYVGART?

Karl, do you want to take this one?

Samantha, thank you for the question. I mean I think there's a potential, but the upside of that is that IV is already available. So maybe the payers won't be in a hurry to make it available to patients. So I think the discussions are ongoing. We think it will take a quarter or 2, but ultimately, we're positive that we will get some of that umbrella coverage.

And your next…

Thank you, Karl. Thank you, Samantha.

And your next question comes from the line of Akash Tewari from Jefferies.

This is Amy on for Akash. Just 3 on our end, if we may. First, for your prefilled syringe, what additional confirmation do you need from the FDA to get this on market? And what are your expectations on time line? Could this be kind of a human factor or bioequivalent study in order to be sufficient? And then on MMN, what was the safety committee looking at specifically in relation to lupus or infection risk? And then can you make any sort of comments on considerations of dosing in cohort 2 and early thoughts on target threshold for C2 suppression? Finally, early thoughts on CIDP pricing now that you have the subcu approved? Given CIDP patients on average seem to receive around 3x more IVIg by volume compared to MG, could we be looking at an annual price of around $300,000 to $400,000 for efgart CIDP?

I think we will start with the first 2 questions. Why don't we [indiscernible] questions until later. I think the dosing for cohort 2, the general framework we need to keep in mind is that the ultimate goal for Phase II is to populate a PK/PD model, which can then interpolate those from Phase III. Luc, do you want to comment on the specific fields of interest being lupus and infection risk and the deliberations of the safety committee?

Yes. So the safety committee got all available data, both clinical, adverse events and lapse that were available to us at that time. With this mode of action, infections, and in particular, one could think about encapsulated bacteria, were, of course, of interest. Nonevents were seen. And with respect to the lupus, that was also evaluated and no changes were seen, neither in respect to the [ alt ] antibodies and so forth. So it was given a clean bill.

Thanks, Luc. I want to call out again the target [ version ] of the C2. If you look at the phenotype of the genetic lockouts, there is no increased risk of lupus really compared to C1 lockouts or all the complement factor lockouts. So I think we're on a safe biology ground and the initial clinical data seem to confirm the ingoing hypothesis. On the PFS, I think you gave us the answer in your question. The building bricks of the dossier will be bioequivalent and human factor study. Right, Luc?

Correct.

Thank you for the question.

Your next question comes from the line of Danielle Brill from Raymond James.

This is Alex on for Danielle. I just want to circle back to the self-administration road map. Just you were mentioning taking some of the learnings from the subcutaneous. I just wanted to see if that -- what formally is the FDA looking for into the potential road map to self-administration? And are we really just waiting for the prefilled syringe for those?

Yes. So one of the obvious advantages of a prefilled syringe is the number of steps it takes to get to the administered form. And I think the agency just looked at the first generation, felt there were too many steps and that the PFS would be a natural more likely to be self-administered formulation. So that's more or less their positioning. What we can learn from in the interactions with this first generation is how the fluctuation does impact, how do we need to adapt our training programs using that as a simplified administration of the PFS and roll that in a human factor study, which again is going to be a key part of that dossier, as Tim mentioned.

And your next question comes from the line of Vikram Purohit from Morgan Stanley.

So we just had 1 on uptake for subcu VYVGART. How do you think the mix of eventual IV versus subcu use could differ between U.S. and ex U.S., assuming you receive approval by early 2024 for subcu VYVGART in the ex U.S. geography that you mentioned you're looking towards in last night's release?

Thanks, Vikram. Karen, this is a question you could take, please?

Absolutely. Thanks for the question. So in terms of the uptake of IV versus subcut, U.S. versus ex U.S., we do expect subcut once approved or if approved, to have a greater uptake ex U.S. because of the dynamics around the infusion centers and the practice economics in the U.S. versus a preference for subcutaneous in markets outside the U.S.

And your next question comes from the line of Alex Thomson from Stifel.

Maybe just 1 on reporting. Maybe, Karl, could you talk a little bit about how you expect to report revenues and if you expect, just give us some understanding around patient adds for the subcu and maybe context around switching between IV and subcu moving forward?

Thank you for the question, Alex. I think with reporting, we will, of course, report revenues separately for subcu and IV. In terms of patient adds and switches, at the moment, we're not planning to provide any specific detail on that in the quarterly earnings calls.

And your next question comes from the line of Allison Bratzel from Piper Sandler.

Congrats on the approval. Just curious with the Hytrulo approval. Is there any reason to think that this dosing format could affect the average treatment cycle lengths in gMG patients? It just seems to us like some docs are starting patients on a fixed-dosing regimen just because it's easier to schedule infusion chair time that way. Just curious how you think that may change or evolve now with a more convenient, non-infused dosing format available.

Allison, thanks for joining us. And this is a great question. What we see in the real world, of course, given the breadth of the label, is that indeed, different physicians decide to use the drug differently. Our experience is that about 1/3 of the patients is really enjoying long periods in between cycles; 1/3 of patients is getting [ related ], let's say, quarterly cycles; and then 1/3 of patients need more frequent dosing. And that's where you see, I think, most initiatives taken by physicians to kind of plan the next infusion. I think your instinct is also our instinct. Maybe the subcutaneous product is uncoupling that patient from the infusion chairs and from the capacity planning and will basically represent 1 step further in the individualization of how we treat MG. Remember, this is what patients want. I mean there are no 2 MG patients the same and they really call out the need for individualized dosing. So we hope and let's see in the marketplace, how it turns out, that subcu is a meaningful addition to that. Thank you.

And your next question comes from the line of Yaron Werber from TD Cowen.

This is Brendan on for Yaron. Congrats to the team. Most of our questions have been addressed. But I did want to ask specifically for MMN. I know we touched on this a bit. But based on what you've seen so far, is there a degree or level of C2 inhibition that you're aiming for now based on the data that you have at hand that you think would provide meaningful improvement? And then maybe if you could just tell us exactly what to expect data-wise from the upcoming release.

Yes. So conceptually, when we think about treatment of MMN to C2 blockade, the question we need to solve for is what is the adequate level of C2 blockade to have a maximum clinical benefit? So I think you can assume that for the 2 different doses and dosing regimens, there's 1 extreme that you go for maximum inhibition, and then there will be other data point which is distinctly different separated from that complete inhibition. And both data points actually should be able to inform the PK/PD model such that we can extrapolate what is that dose we need going forward. So Luc, is there anything you want to add to that concept?

The only one I want to add is that this particular antibody is also designed to have a long effect. And one of the key features that patients have to deal with, with IVIg treatment, is their fluctuations. So aside from just a level of improvement, it's also the duration of improvement in terms of either staying stable or, as we hope, the system repairs, even improving over time. So it's not just being able to treat but also treat in a different way where people do not have to have these worsening of treatment and then go and get another course of IVIg.

Thank you, Luc.

And your next question comes from the line of Joel Beatty from Baird.

So what do you anticipate will be the most likely administration setting for Hytrulo such as provider office or a patient's home?

Karen?

We believe it will be a mix between provider office and patient's home. Of course, patients receiving it in the home will mostly be commercial. And we do see that already through some of our infusion patients. But we believe that, that opportunity will expand with the more simple subcutaneous offering. So we believe that this will be as a Part B medicine, with both infusion and subcutaneous. There will be HCP administration and some home infusion or home administration expanding from the amount of home administration that we have today.

And your next question comes from the line of Jason Butler from JMP Securities.

It's Roy on for Jason. Just a quick one. Just what are your expectations for early subcu [Audio Gap] versus the academic setting?

I think you broke up, Jason (sic) [ Roy ], but I think the question is expectations in terms of uptake between community and academic centers for subcu. Is that correct?

Correct. Yes.

Karen, can you comment on that, please, now that we know the question?

Yes, absolutely. I mean I think to start with when we've spoken to physicians, whether they're academic centers or in the community, generally, there is excitement to have the opportunity or the option for an infusion and subcutaneous. I think it's going to depend a little bit on the dynamics of the local market what you'll see in terms of the uptake between those. And I'll comment on 2 dynamics. One, I do think you'll see expansion in community neurologists because of the more -- the shorter going to 30 -- 90 seconds for an injection rather than the infusion. It also seems like less of a step going from, say, an oral to an injection like that. So we'll definitely see some uptake in the community. In academic set, there might be a different dynamic where there's challenges with infusion capacity or just general site of care challenges in terms of cost and payer dynamics. So you might see some uptake there as well. But I think the real benefit will be that depending on the patient's preference, the prescriber's unique situation, there is an option for either, and we'll be able to meet the patient where they are.

And your next question comes from the line of Douglas Tsao from H.C. Wainwright.

So one for me, just 117, I'm just curious. When do we expect to get the final readout from the Phase II study? And can you just provide an update where you are in terms of enrollment?

Thank you, Douglas, for the question. And, Luc, we have the benefit of having you here. How do we talk about the readouts of Phase II and status?

Yes. So again, as this is, for us, a learning study, there's going to be multiple additional readouts to inform what we're going to do in Phase III. And the first interim analysis will be when we have the full data for the first cohort, which we expect to have sometime in October. The second cohort, in fact, the dosing for that will start next Tuesday. And then we have a cadence of patients already lined up to fill of that cohort. But one of the drivers, and this is specifically the design, is for each patient, what is their IVIg cadence because we need to know that before being able to dose them and that creates some uncertainty on the back end. So yes, sometime early next year, I think we will have cohort 2.

Yes. Thank you, Luc. And thank you, Douglas, for the question.

Your next question comes from the line of Joon Lee from Truist Securities.

This is [ Assam ] on for Joon. Just wondering, do you think there may be a bolus of patients waiting on the sideline for subcutaneous VYVGART?

Yes. Thanks for joining and thanks for the question. I believe Karen probably, so I can quickly repeat it. No, we do not believe there has been a kind of warehousing of patients which are now waiting for subcu and refuse to get on IV. So think of the subcu product as a tool to maintain the loss trajectory and do not expect anything close to a bolus. Okay? Thanks for the question.

And your next question comes from the line of Myles Minter from William Blair.

Congrats on the approval. Just 1 for me. Do you have any clarity now that this product has been approved [ so I could watch for good ] the major amendment during the BLA filing? Was it something to do with additional data on those anti-acetylcholine receptor negative patients or the route of administration and the need for an HCP to administer it? Just trying to get some additional clarity over whether this was specific to the filing or something we should think more broadly about this SC product moving forward?

Thank you for the question. This is a personal opinion. We do not believe that either the acetylcholine receptor negative patients or the self-administration was the reason for the initial delay because these are topics which only popped up during the label conversations or the label negotiations. So it remains difficult for us to really get our finger behind the initial clock extension. And technically speaking, of course, people remind us of the fact that we still did receive a priority review because we're still arriving early at the finish line. But thanks for the question.

And your next question comes from the line of Xian Deng from UBS.

Just 1, please. Sort of a general question on 117. It seems there might be some indication overlap with [ CRN ] and VYVGART. For example, dermatomyositis could also be part of myositis that you're running the trial with VYVGART. MMN also has anti-GM1 autoantibody involvement. So one could argue that there could be a rationale to try VYVGART, so just wondering. On a sort of broad level, just wondering how do you select which drug to go for which indication? What is your general strategy for 117 together with VYVGART?

Thank you for that question. So the biology of dermatomyositis actually has both modes of action in operation. And we feel that we need to provide the evidence for both -- for each of these separately. As you know, efgart is studying in myositis actually 3 subtypes and for C2, the 117 or empa for short. We are looking at dermatomyositis specifically. So from a disease, there is clearly an indication overlap. But from how these 2 assets might impact it, I think it's important to generate the data separately. Afterwards, we can always look, based on data, whether there's usefulness in either a regimen or a combination approach.

Yes. So when you start from the biology, I think there are 2 distinctly different populations. Like one would -- clearly the complement is in the driver's seat with no detectable antibody in the biopsy. Whilst, for the other subset, you clearly see an autoantibody depositing and then recruiting, effective function including complement. So that's correct. We are looking at those both.

We will test both. Yes.

Thank you.

And there are no further questions at this time. This does conclude today's conference call. We thank you for your participation, and you may now disconnect.