Tim Van Hauwermeiren: Thank you, Yaron. From a patient population point of view we expect the real world population. That means that the majority of the patients of course, will have been on therapy, with maybe some naive patients in there as well. I would caution against extrapolating from rituximab trials in terms of endpoints, which are different duration of treatment, which are different background stereotyping protocols, which are different. And therefore placebo behavior in that trial cannot just be extrapolated into our trial, the way we designed the primary endpoint is such similar to IDP, by the way that we try to really minimize any placebo response in the 30-week trial. So, let’s not extrapolates, let’s not assume similar placebo responses of deltas, between active and placebo.
This is its own unique trial design. And we would be very happy to see statistically significant delta emerge, between the placebo arm and the active, it’s a very aggressive endpoint. Thank you for the question.
Operator: Your next question comes from the line of Myles Minter from William Blair. Your line is open.
Myles Minter: Hi, thanks for taking the question. I think I was on – previously actually announced some data showing that they can get a 10 ml auto injector in about a 30 second injection time. I know, you’re advancing up prefilled syringe version of VYVGART Hytrulo, and that’s in development, you can update us next year. But would that also potentially mean you’d introduce an auto injector solution based on that? I had to up data? Thanks.
Tim Van Hauwermeiren: No, thank you for the question Myles, if anything is just shows you the power of the enhanced technology from Halozyme. And it underscores again how important this technology is to win in the subcu setting. And we’re very happy to have the exclusive license to the technology, which positions us in a position of strength. We’re the only product out there, which can deliver a single subcu injection with this volume of products. And auto injector of course, is in the works. As you know, argenx is always planning for multiple steps ahead. So, we were really feeling a sense of urgency, to launch this first generation subcu product ASAP, because patients are waiting, that we are already working on the prefilled syringe.
And we have also been public on the fact that we are working on an auto injector as a third generation. So the data from Halozyme are boarding very well. And they underscore the power of the Halozyme technology in order to delight patients in the subcu setting. So stay tuned and more news will come next year. Thank you.
Operator: Your next question comes from the line of Joel Beatty from Baird. Your line is open.
Joel Beatty: Hi, thanks for taking the question. For the post COVID pops data in Q1, what would be good data? And could good data that will be supportive of further development of – other settings?
Tim Van Hauwermeiren: Yes, this is an excellent question. So, this is one of the few indications where actually we need to go for signal finding first. I think there’s a strong hypothesis, which was delivered, to us by the key opinion leaders in post-COVID pops that this is IgG-mediated. We need to establish a firm signal in what is, a true Phase 2 trial hidden at post COVID pops. Before then we can think about venturing into the Phase 3 trials. So, we will be looking at the totality of data. And we will see conviction that is truly IgG mediated. So, we have some fundamental answers, to be given before we can go into Phase 3. We believe that post COVID pops based on the data we have seen, is not different from regular pops. But the experiment is ongoing and we need to show the data now. Thank you for the question.
Operator: Your next question comes from the line of Alex Thompson from Stiefel. Your line is open.
Alex Thompson: Hi, thanks for taking my question. I guess a question for Karl. How should we think about the net price per patient for VYVGART now in Europe, now that we have the final German price? How should we think about modeling that moving forward? Thanks.
Karl Gubitz: Thank you, Alex. Yes, as a reminder, we launched in September ’22. And we got the final price in August ’23. We’re very pleased with the outcome as it recognized the clinical benefit. And that of course resulted in the $6 million true-up, which I reflected early on. At the moment, our price – our European business of course, is largely Germany. And I do have to mention, I think, but in Germany, orphan drugs are subjected to a full AMNOG process. And renegotiate if your annual revenue exceeds $30 million. And we have now exceeded that threshold. Basically, what I’m saying is that we will go back and renegotiate again. So, we expect that price to drop – during 2024. That said, we are pleased to have a strong commercial performance, which resulted invoice and we are pleased with our partnership with a German for addition, look forward to continue discussions with then for planning purposes, of course, I think Alex, you have to assume that the European price will be lower than the U.S. price.
Thank you.
Operator: Your next question comes from the line of Allison Bratzel from Piper Sandler. Your line is open.
Allison Bratzel: Hi, good morning. Thanks for taking my question. And congrats on all the progress. Just one for you on the early experience with VYVGART Hytrulo. I know its early days in the launch. But just curious if we have any insight just on the profile of early adopters of the subcu format, you know, is initial uptake concentrated among neurologists who are already heavy prescribers of IV VYVGART. Or just what are you seeing there? And then I know you indicated that such a low uptake is primarily in the VYVGART naive patients so far. But just as Hytrulo coverage policies are put into place, kind of hoping you could walk us through what you would expect would be the major barriers preventing a patient from switching just from IV to subcu.
And then just second separately. Just a point of clarification. I think you talked about a 7 million in product sales to Zai Lab. Was that – that was commercial supply related, I think, could you just confirm that, and how we should think about just modeling that this quarter and going forward? Thanks.
Tim Van Hauwermeiren: Thanks, Allison. I will give question to Karl in a minute to comment about, the transfer of goods to Zai Lab in China. But maybe and Karen, you want to go on first on Hytrulo launch dynamics, and patient phenotypes we get on drug?
Karen Massey: Yes, absolutely. Thanks for the question. We’re really excited about where we are with the Hytrulo launch, I would say we are getting positive feedback from – neurologists, from patients. And as you mentioned in your question, payer policies are now going into place, and they broadly reflect IV policies. So it’s clear that the market is responding well, to this innovation. That is that has been brought forward. You mentioned and I’ll just reinforce the majority of patients that we’re seeing of they’ve got naive patients. So, this is expanding the pool of patients that are considering they’ve got and we are adding new prescribers, with they’ve got Hytrulo as well. So, if you go back to what we’ve talked, about is this very intentional and very consistent approach to VYVGART, and we’ve got Hytrulo, where we were focused on expanding quarter-over-quarter, the prescribers that have experience and confidence with VYVGART and VYVGART Hytrulo expanding the patience to go in earlier line.
