argenx SE (NASDAQ:ARGX) Q3 2023 Earnings Call Transcript

Tim Van Hauwermeiren: Thank you, Karen. And then on the BP question, look, we’re not in a different situation than we are in the other indications. But it is true. There is other medications out there, you know, which can be done at a cheaper price. The question is, of course, what value do they offer. So, we believe that bullous pemphigoid is a very difficult disease to treat. There’s actually very little competition or competitive activity in development going on for the moment. And just like pemphigus, this is an IgG driven disease. This is IgG-mediated. And therefore we think that by hitting the disease in its heart, we can have a dramatic impact in these patients. And let’s start with the clinical benefits which we can demonstrate in these patients to then derive the value, because it will all send around the value we offer for these patients.

So I think let’s wait for the data. But if the data pan out in a similar direction is what we have seen earlier in pemphigus, I think put in a very strong position to really transform the lives of these patients, and be able to extract the coding value from that. Thank you for the question.

Operator: Your next question comes from line of Douglas Tsao from H.C. Wainwright. Your line is open.

Douglas Tsao: Good morning. Sorry about that. Thanks for taking the questions. I’m just curious, in terms of the early launch of Hytrulo for, you’ve obviously mentioned that it’s largely patients who had not switching new patients to therapy. I’m just curious what was necessarily holding them back? Or was it just a matter of prescribers getting to these patients, or for some of these patients is not willing to go on to therapy with the ID?

Karen Massey: Yes, thanks for the question. It’s a good one. Look, I don’t think there was anything holding them back, necessarily. I think this is we’re early in the adoption curves still have, they’ve got even seven quarters in. And I think VYVGART Hytrulo gave the opportunity for new prescribers. That might not have considered VYVGART before. Suddenly we have the DTC campaign, highlighting Hytrulo patients for perhaps say – they felt that an IV was for a more severe disease and they wanted to be on. So it opened up maybe some different patients. But overall, I would say the trajectory of the launch is just based on as prescribers and patients get more experience with VYVGART, they see the impact in terms of their quality of life.

As I’ve mentioned a few times the fact that the safety profile continues to hold up. And now we have these two routes of administration. I think what we’ll see is just that continued momentum and consistency in expanding with prescribers and patients. Thanks for the question.

Operator: Your next question comes from the line Joon Lee with Truist Securities. Your line is open.

Joon Lee: Hi. Congrats on the strong quarter and thanks for taking our questions. I have missed this but are you still on track to start trial by year end? Just didn’t seem to – I might have missed out on the press release. Thank you.

Tim Van Hauwermeiren: Hi Joon, thank you for the question. Yes, was simple. We are on track. So actually, we don’t track with all of the clinical milestones which we had promised at the beginning of the year. So very proud of the execution power of the team. We have a ton of work in front of us. But these are all very exciting indications. So yes, we are on track and thank you for the question.

Operator: Your next question comes from the line of Suzanne van Voorthuizen from VLK. Your line is open.

Suzanne van Voorthuizen: Hi, Tim, thank you for taking my question. It’s more of a long term using but I wanted to ask your thoughts on the more recent development where CAR T players are moving in autoimmunity, they seek to potentially cure lupus, but some players are also moving into indications not too distant from argenx like myositis. So could you please elaborate a bit on how you look at this development? What are your thoughts on the position of this potential future modality versus VYVGART? Or if you have any other considerations that you think are relevant? Thank you.

Tim Van Hauwermeiren: Hi Suzanne, and thank you for being with us today and on the call. Yes, of course, we’re watching all sorts of innovation coming into the autoimmune space. I think it’s an exciting time to be in autoimmunity these days, with multiple, you know, different modalities coming in. We’re looking at the CAR T technology, of course. To be fair and honest, we need a bit more data. So I think we have all seen that small set of data in asleep patients. Let’s see, you know, how these CAR T data play out in the different indications. And I think everyone will be focusing, of course on you know, what will be the durability of the clinical response, which we can expect with this type of technologies, which very early days, let’s wait for the data.

And of course, we’re closely monitoring that. Now, our ambition and autoimmunity as Karen explained earlier in the call, is not to wait with expensive innovation until your last line patients, but to actually move with affordable innovation early in the treatment paradigms. So we can hit a disease heart early and hopefully avoid these very bad relapsed refractory patients, which are outreach nothing works anymore. So, that is our mission in autoimmunity, bring the innovation as early as we can in the treatment paradigm to hold further progression of disease and prevent patients from getting in that final station. Thank you for the question.

Operator: Your next question comes from the line of Samantha Semenkow from Citi. Your line is open.

Samantha Semenkow: Hi, good morning. Thanks for taking the questions. Just a couple of follow up questions for me. Just from a timing perspective should be expect both the pemphigus and bullous pemphigoid data to be read out at the same time or is the guidance just they will be read out near each other around year end. And then also for pemphigus. When we look at the Phase 2 data, about 20% of the patients, they seem to have achieved CRM main endpoint within about the 30-week timeframe, just recognizing that [indiscernible] dose and the dose schedule as well as they’re adjusting was different in the Phase 2 than it is in Phase 3. How should we think about that translating into the readout for the ADDRESS study? Is that 20% around where you expect the bar or would you expect it to be different than that? Thank you.

Tim Van Hauwermeiren: Thank you for both questions, Samantha. So from a timing point of view, we’re not going to go into get any more granular than what we have been disclosing publicly. Let the teams navigate the Christmas period. Let them do a thorough data analysis. And then we can come out of the gate with the data. But there will be close together on extrapolating from pemphigoid Phase 2 to Phase 3, remember that the objective of Phase 2 was something totally different rights. This is the only indication where we studied monotherapy of VYVGART’s, then combination therapy at different doses and dosing regimens with low dose of steroids. And therefore you cannot just look at numbers. I think what we did in Phase 2 is fine tune the dose, the dosing regimen and the ideal combination with steroids to then take that ideal combination into Phase 3.

So we did test drive the ideal combination with quite spectacular results. But it was relatively small, patient numbers. And that’s why now we do the proper Phase 3 experiment. Thank you for the questions.