argenx SE (NASDAQ:ARGX) Q4 2023 Earnings Call Transcript

Andy Chen: Thank you for taking the question. Can you talk about empasiprubart a bit and the sequencing of indications? I know you have named the three indications, but how were these chosen and prioritized? Are these the best indications commercially or are these the best indications scientifically, given the mechanism and disease pathogenesis? And obviously, what are the key decision-making factors when you choose the next few indications? Thank you.

Karl Gubitz: Yes. This is the typical way argenx works. We always start from the biology. We’re not going to force fit biology with what looks like a great commercial opportunity to then fail in the clinical trial. We follow biology and the three indications we’ve public on our MMN, which we showed recently data, where we believe the pathogenic RGM autoantibody is actually the driver of the disease and actually the truing complement and we are sure we can block that very effectively. The second indication is delayed graft function. That is actually in the kidney transplant setting and there is again very compelling evidence, the classical and the lectin pathway is in play if you look at the kidney biopsy and therefore C2, which is at the nexus of both pathways is an ideal target to block delayed graft function, which actually leads to significant kidney loss in the transplant setting.

The value of that organ is very high. It’s a high unmet medical need. It’s an effective commercial setting. And then the third indication is dermatomyositis, which we already touched on. We have more indications in the works, but we always start from biology. Then we will actually look at the ability to do a clinical trial experiment in terms of the visibility of clinical endpoints, approvable endpoints, ability to enroll the trial, also ability to show the signal despite taking our medication. And then finally, of course, we take a careful look at unmet medical needs and the ability to shape the treatment paradigm, which are two pillars to formulate the commercial rationale. So all the indications have been carefully selected based on these filters and more indications are underway.

So we think this is our next pipeline in the product.

Operator: This ends our question-and-answer period and does conclude today’s conference call. Thank you for your participation. You may now disconnect.