Tim Van Hauwermeiren: Yes. So as we announced the Phase 3 study campaign is open. We are enrolling whilst we speak. This will be a global trial also involving our partner Zai Lab in China. It’s a sizable market opportunity and I think in the current treatment paradigm, it is becoming clear what the shortcomings are of the currently available medications. It’s a relatively similar patient population which we are enrolling in our studies as compared to the [indiscernible] studies. Of course now also involving a capped number of patients which can have seen [indiscernible] in their lives. And that’s where we’re going to stick with the update today on TED and I think we will be ready to talk more about it when we’re deeper into these studies. But the big news today is study is life and is also using by the way the PFS.
Operator: Your next question comes from the line of Alex Thompson from Stifel. Your line is open.
Alex Thompson: Hey, great. Thanks for taking my question. I guess I wanted to ask about self-administration and for CIDP the expectation for potential self-administration at launch or whether the PFS is really the route to achieving self-administration and the label for both CIDP and MG. Thanks.
Karen Massey: Yes. Thanks for the question. We think self-administration is a really important step forward overall as we continue with our expansion strategy for VYVGART and VYVGART Hytrulo. So the label for if approved in CIDP will be for the current Hytrulo label. So that would be for HCP administration. But as we shared earlier, in the call, we’re excited about the progress we’re making with the prefilled syringe, and the path there, according to the plan that we’ve laid out is that we will have discussions around self-administration and we think that there’s a good a positive path forward there for both MG and CIDP. But, of course, it’s always, up to the FDA and a review issue.
Operator: Your next question comes from the line of Xian Deng from UBS. Your line is open.
Xian Deng: Hi. Xian from UBS. Thank you for taking my question. Just a general question on Sjogren’s please. So Sjogren’s has traditionally been a challenging disease for mobile biologic. So just wondering, you know, what gives you the confidence in VYVGART in Phase 3? Do you think it’s a mechanism, you know, FcRn is a target of some biomarker data you have collected, or it’s a primary endpoint? We know you already, you know, use the composite endpoint, which is arguably more comprehensive than some others. But on the other hand, you know, Sjogren’s, you probably also going to have quite some patients with a lot of prior medications. So just wondering, yeah, any thoughts on that that would be great. Thank you.
Tim Van Hauwermeiren: Yeah. Thanks for the question. Sjogren’s, so the Phase 2 signal finding study served two big purposes. Purpose one was to establish confidence in the disease biology and our understanding of the biology. Objective two was to really learn about do’s and don’ts for the Phase 3 clinical trial design. So let’s start with objective number one. I think we see a very convincing biological signal here that by blocking FcRn you’re effectively eliminating the circulating immune complexes which we think are the triggers of the disease and by clearing these circulating immune complexes you basically see a downstream effect in how the immune cell infiltration is going down in the glands and how systemic signs are actually improving and improving across multiple clinical scales hand-in-hand so consistently.
Now that’s exactly what we wanted to see in addition to a positive Phase 2 trial as announced for Nipocalimab by our colleagues from J&J. Secondly, we learned a great deal about potential impact of background medication and how to mitigate that, the imperfections of the currently used endpoints. So I think all-in-all we have conviction in the datasets and we are actually equipped to now go into our end of Phase 2 meeting with the FDA to discuss our proposal for Phase 3. Thanks for the question.
Operator: Your next question comes from the line of Vikram Prahoejit from Morgan Stanley. Your line is open.
Vikram Purohit: Hi. Good morning. Thanks for taking our questions. So we just had two on the pipeline. First on empasiprubart for MMN which is curious if you could talk a bit about what that Phase 3 study could look like and just kind of how you are characterizing that commercial opportunity and then for pipeline readouts for this year, how are you thinking about the potential outcomes for the ALPHA and ALKIVIA datasets, and what would constitute strong outcomes there from your perspective? Thank you.
Tim Van Hauwermeiren: Yes, thank you for all these questions. I think MMN is a sizable opportunity. Of course, it’s a rare disease. It is a disease, which is I think under diagnosed and under treated. As we know the only available therapy out there is IVIG and similar to markets like for example MG, I would not be surprised to see this market grow substantially with real innovation coming in. I think from a trial design point of view, we are very well equipped to get ready for Phase 3 because the main objective of the Phase 2 clinical trial of course next to establishing proof-of-concept was to establish a dose response range where we can basically populate our PK/PD model and predict the Phase 3 dose and dosing regimen. I think we are very close to that point.
We also had a very rich trial here in terms of clinical endpoints and we already said that all clinical endpoints really moved in sync with each other. So we will be able to have a real educated discussion with the FDA about which endpoint we would suggest and why we would be suggesting that endpoint out of the many ones which we tested. So I think we will be in a strong position to engage in that end of Phase 2 discussion with the FDA relatively soon. In terms of other outcomes this year, we are of course waiting now after the positive Phase 2 data for Sjogren’s. We are waiting for the PC-POTS data, which should come in before the middle of the year and then of course the three myositis trials which will come in during the second half of the year.
Similar to Sjogren’s in PC-POTS, we will be really looking for proof-of-biology and whilst you should be thinking of the go, no-go decision point in the myositis studies in a similar fashion as we designed them for the CIDP study. So we will want to see a signal which is reasonably to be expected stronger than what a placebo signal could be in order to advance in one, two or three of these subsets of myositis and we will be communicating about these go, no-gos at the same time for all three indications. Thanks for the questions.
Operator: Your next question comes from the line of Danielle Brill from Raymond James. Your line is open.
Danielle Brill: Hey, guys. Good morning. Thanks so much for the question. I want to circle back to the CIDP launch. Based on recent doc checks, it seems like many patients may have already been earmarked for therapy with VYVGART. I’m wondering what feedback you’re encountering in your market research. And is there any reason at this point to think that the launch cadence won’t be similar to what we saw in MG? Thank you.
Karen Massey: Well, thanks for the question, Danielle. And we’re seeing something similar in market research in one way is in that there is excitement, amongst prescribers and patients about VYVGART, and the potential. We are not seeing that there’s a bolus of patients that are waiting. And in particular, the prescribers have the same question that that many of us have, which is when will the payor policies come online. And we know, that payor policies generally take a couple of quarters to come online after an approval. So I think the uptake, combined with the payor policies coming online, that patient stickiness to IVIG that I talked about a little bit earlier, as well as the fact that IVIG is approved in this indication, and will be a strong competitor.
I think that means that that we can expect to see maybe a little bit of a slower uptake versus MG. However, once we start to get the patient switches happening and once we start to shift the market, then I think that I’m confident that that over the long-term, this is a big opportunity, even if it won’t be easy in the first days. Thanks for the question.
Operator: Your next question comes from the line of Suzanne van Voorthuizen from Van Lanschot Kempen. Your line is open.
Unidentified Analyst: Hi. It’s Cara Monteironi. I’m on behalf of Suzanne. So I out of curiosity, again, on the drop of the ANCA program, which was replaced by SEC. I was wondering how those two indication compare in terms of effort, trial design, timelines or anything that you wish to highlight? Thank you.
Tim Van Hauwermeiren: Roughly speaking, I would park them in the same ballpark in terms of size of opportunity and size of investment. And the unmet medical need in AAV is substantial. The biology by the way is very strong. Actually the disease is called after these autoantibodies and we saw a recent case report published with spectacular data for VYVGART in the hands of physicians in the real world. The real issue for AAV I think is the confounding factor of the background medication. The mandated use of high dose of steroids is actually going to blur the effect of VYVGART. And we looked at it from multiple angles, but there is no credible way to go through that steroid barriers despite a high unmet medical needs. That is quite different in systemic scleroderma.
So equally high unmet medical needs, equal number of patients, equally strong biological rationale, but I think a more straightforward path in clinical development. That’s how I would call it for the time being.
Operator: Your next question comes from the line of Samantha Simankow from Citi. Your line is open.
Samantha Semenkow: Good morning and thank you for taking the question. My question is just on the uptake of Hytrulo. Is the growth that you highlighted in the prepared remarks, is that a recent uptake or has it been steadily climbing over the last several quarters? And then as you think about introducing PFS as an approved option formulation, would you expect a similar trajectory of growth for the PFS or would you expected to be a sharper uptake. Thank you.
Karen Massey: Yes. Thanks for the question, Samantha. I’ll take that. We actually did see an acceleration in the uptake of Hytrulo in Q1 and there were specific reasons for that, namely that the payor policies were in place and the J-Code was established in Q1. So we did see an acceleration. We expect that to continue, and it’s important to note just talking about it with the CDC launch, it did take about two quarters for those payor policies to come into place, with Hytrulo. So we’ve seen that now. In moving forward, I think, we’re very excited about the pre-filled syringe and being able to offer an even broader product presentation options to patients. I do think it’s a significant advancement on the current Gen One of Hytrulo and I do think it will enable us to further move up to earlier lines of treatment with VYVGART and further advance or expand our prescriber base as well.
So we do see that PFS will be another engine for growth, if you will, for VYVGART. Thanks for the question.
Operator: Your next question comes from the line of Gavin Clark-Gartner from Evercore ISI. Your line is open.
Gavin Clark-Gartner: Hey, thanks for taking the question. On Empa in the pipeline, I believe, you’ve noted there’s been no cases of lupus in the ongoing MMN study. But I also wanted to ask about rates of ANA tighter elevations, specifically, any other markers such as dsDNA? Thank you.
Tim Van Hauwermeiren: Yes, that’s a great question and a potential differentiator actually for C2 versus the C1s.No, we did not see any increase of such status and at least from a theoretical point of view, we have always believed this could be one of the advantages of an anti-C2 antibody. So none of these signs and a great opportunity for me to remind everyone on the call that the Phase 1 data both for IV and Subcu came out with spic and span safety and tolerability data. So far so good. Thanks for the question.
Operator: Your next question comes from the line of Yatin Suneja from Guggenheim. Your line is open.
Yatin Suneja: Hi. Quick one for me. On VYVGART could you comment on what you’re seeing in terms of discontinuation there? Is it in that 20% range? And then anything you are able to say on number of cycles that you are able that patients are getting? Thanks.
Tim Van Hauwermeiren: Thank you for the question. On discontinuation, as you know, 20% of the patients from the DAP study did not respond. So you would expect this continuation to be 20% plus because there are also other reasons. And what we see in the real world is in line with our expectations and that has been consistent since launch. In terms of the number of cycles, the number of cycles for IV has also been consistent and we’re about and it’s around 5% as we previously said. So there’s been no change. Thank you.
Operator: Your next question comes from the line of Victor Floch from BNP Paribas. Your line is open.
Victor Floch: Hi. Thanks a lot for taking my question. Victor Floch from BNP Paribas Exane. So a couple of questions on my side. First, I was wondering if it’s fair to say that the SG&A cost facing which in this quarter is reflecting a higher need to build that awareness, right, of launch in CDIP than what was needed for MG back in the day. So if you could just remind us the key challenges in CDIP compared to MG would be appreciated. And my second question is about ITP. And so I was just wondering if you could update us on your efforts to potentially expand the ITP opportunity beyond Japan. So I don’t know what is in the balance to take any decision and if you could commit to any timing, but yeah any color on that would be very much appreciated. Thanks a lot.
Tim Van Hauwermeiren: Thank you for the question. I will give the floor in a minute to Karl who is going to comment on the increase in SG&A expenses in preparation of the CIDP launch. Karl, you will be able to give some color there. Thank you for your question on ITP. We are of course delighted to see the PMD approval for ITP. We see the first patients coming on product very quickly underscoring I think the unmet medical needs which is present in ITP. And I think it’s fair to say that throughout the interactions with the PMD, we also gained a number of insights we can use to actually pivot back to the FDA for a follow-up conversation and that’s exactly what the team is preparing. I think we are equipped now to go back to the FDA for a dialogue to see whether we can make progress on the ITP front.
So stay tuned. I certainly don’t want to overpromise, but I think we’re going to make an extra effort there which I think we owe to ITP patients. Karl, would you mind commenting on the SG&A question?
Karl Gubitz: Okay. Yes. SG&A increased by around $27 million in Q1 ’24 versus the end of last quarter in 2023. That increase is largely driven by the incremental infrastructure we put in place in the US versus customer facing colleagues, which will be promoting gMG today. And as we said previously, we believe that the gMG opportunity is bigger than what we originally thought and now we’re expanding that footprint. That same footprint will also be used for the CIDP launch subject to approval later this year. Also part of that increase is the geographical expansion. You’ve heard us talk about certain markets like Italy and Spain and other European markets where we’re starting to have sales. We’ve been very disciplined to guide any expenses in those markets until we have pricing and reimbursement in place.
