argenx SE (NASDAQ:ARGX) Q1 2024 Earnings Call Transcript

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And as we start seeing sales in both markets, we are investing in both markets. So it is the US and the geographical expansion which is driving that increase. Thank you for the question.

Operator: Your next question comes from the line of Joel Beatty from Baird. Your line is now open.

Joel Beatty: Thanks for taking the question. With Q1 typically being a challenging quarter, how did the trajectory of VYVGART sales change over the course of the quarter into early Q2?

Karen Massey: Yes. Thanks for the question. As you say, Q1 is notoriously challenging in particular in the US with holidays and recertifications and weather, et cetera. We’re really pleased to be with the growth, the quarter-on-quarter growth that we delivered in the US as well as the year-on-year growth. I mean, it was 76%, year-on-year growth, for the US. What we’re seeing and what we feel is confidence that the underlying fundamentals of what we delivered in Q1 were very strong and I went over a few of those whether you look at new patient growth, where the patients are coming from, we’re advancing market share, all of those factors, and we’re seeing that continue into Q2. So we’re confident, in the remainder of the year.

Operator: Your next question comes from the line of Manos Mastorakis from Deutsche Bank. Your line is open.

Manos Mastorakis: Hello. Thank you for taking my question. Just basically on the key learnings you took away from the exercise you did across indications and which led to the discontinuation of ANCA vasculitis and how do some of those learnings extend to empasiprubart? Thank you.

Tim Van Hauwermeiren: Thank you. It’s a great question. Actually when we did the portfolio review, we did not only limited to efgartigimod, we immediately included also the Empa indications. So we did a full review of all planned and ongoing indications and we gained confidence for all Empa indications which are currently on the rails, but also the ones which we’re planning in addition that actually we can master the impact of the background medication. So I feel very strong about the big efforts all the teams did in such a short period of time following the pemphigus data. We’ve thoroughly double clicked on trial designs, understanding the impact of background medication and whether or not we are actually equipped to deal with those.

So exercise has landed and actually most indications remain on track with the exception of AAV where we no longer feel it’s an responsible allocation of capital to take such a risk from a background medication point of view. Thanks for the question.

Operator: Your next question comes from the line of Matt Phipps from William Blair. Your line is open.

Matt Phipps: Thanks for taking my question. Two quick ones. First, on the human factor studies, did you use CID patients in that study? I’m just wondering if somebody with reduced grip strength would be suitable for self-administrated PFS. And then, I guess, following the potential CID approval, given, what you said about the payor policies, would you plan to provide some kind of free drug program given the, you know, underlying patient interest and demand?

Tim Van Hauwermeiren: Thank you for the two questions. I will hand over the second question in terms of launch preparation to Karen, although I suspect we will not be showing too much of our [indiscernible]. From a human factor study point of view, you’re absolutely right. I mean, we’re targeting the pre-filled syringe for both gMG and CIDP patients. So you can imagine that in the human factor studies both patient groups were actively involved and we feel very strong about the data which we achieved and we feel very strong about the submission which is now in the works before end of June. Karen, question two please.

Karen Massey: Yes, happy to. Without going into too many details exactly on what our plans are. Maybe the best way to answer that is we’re taking the same approach to the CIDP launch preparation as we did with MG. And the way that I would characterise that is that we’re being really thinking very innovatively about how we want to go to market, how we want to empower patients, how we want to educate prescribers. And we’re also be thinking in a very disciplined way, around our execution, and how do we make sure that we’re making the right capital investments or the right use of our capital, and making the right investments. So we’ll take that same approach for the CIDP launch that we did for MG.

Operator: And your final question comes from the line of Douglas Tsao from H. C. Wainwright. Your line is open.

Douglas Tsao: Hi. Good morning. Thanks for taking the questions. Just a quick one for me. I’m just curious, ultimately when we think about the different presentations of efgartigimod, I mean, where do you see the pre-filled syringe ultimately falling between the Subcu and the IV? I mean do you think that this could ultimately become the sort of dominant presentation that’s utilized? Thank you.

Tim Van Hauwermeiren: Yes. Thank you for the question. So, we are a patient centric company and it’s our ambition to serve the needs of the individual patient segments as completely as we can. We believe that especially in the US market the IV product will always be important because a subset of patients, but also actually physicians do prefer an IV infusion. The interesting thing about VYVGART Hytrulo today is that it’s actually a very clean and easy execution which is still resolving under mainly I would say Medicare Part B whilst the PFS with the self-administration is mainly going to target I think or sit in the Medicare Part D channel. So if you think about the market leaders who is patient centric, I think, the PFS will be the closing piece in the totality of the product offering maximally serving I think different needs and preferences of different market segments. Thanks for the question.

Operator: And we have now reached the end of our question-and-answer period. This concludes today’s conference call. Thank you for your participation. You may now disconnect.

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