argenx SE (NASDAQ:ARGX) Q4 2022 Earnings Call Transcript

Page 9 of 10

Tim Van Hauwermeiren: Oh, okay, I got it. Keith, I will hand over the question to you on what we expect in the context of European rollout for the drug this year. From an production point of view, what I would like to leave you with conceptually is that, of course, there are multiple layers of IP protection protecting VYVGART. Of course, we have the specific limitations which we used and in license, actually from then indeed we have the composition of mega claims, which are on roughly speaking, to 2035. But then we have additional composition of matter and formulation patents which we continue to file on the back of clinical data. So we have not been public. I would explicit on the final IP horizon for the molecule, but there is significant IP life in the making above and beyond decomposition of claims you just referred to. Keith, you want to comment on the European rollout, please?

Keith Woods: Yes, happy to do so, Tim. So as you know, we are currently in the AMNOG process in Germany and VYVGART is available in Germany and we’re off to a successful launch there. But we will continue to go through that reimbursement process to have final and official approval in quarter three, late quarter three of this year. Also in France, we’re in an AP2 program, which makes VYVGART available to patients. It’s not quite as broad as the label at this point, but it does give access to patients that need it, while we continue to go through the reimbursement process in France. We’ve submitted dossies in numerous countries across Europe, including that of Italy. We’ve been working with the U.K. and Spain. I want to call out that we have a broad preapproval access program so that we can begin to serve patients. But basically, this is all going to be based on the timeline of gaining approved reimbursement on a country by country basis.

Operator: And your next question comes from the line of Charles Pitman from Barclays. Your line is open.

Charles Pitman: Hi. Thank you very much for taking my questions. I apologies if these are any repeats. But just — first on OpEx. Could you give us an idea of how this is going to progress over 2023? R&D obviously came in a bit light at 4Q. I’m just thinking in terms of you’ve got a number of pivotal trials set to readout ahead of the earlier stage trials starting in 4Q 2023 and kind of how you’re controlling costs? And then secondly, we have top line data around the corner for pemphigus . I was wondering if you could just update us on how these trials are proceeding and maybe particularly what you’re trying to — what you’re hoping to demonstrate from the trial readouts? Thanks.

Tim Van Hauwermeiren: Karl if you would take the OpEx question, then I will take the pemphigus question. Okay? Thank you.

Karl Gubitz: Thank you. And thank you, Charles, for the question. I think if we — I mean, we don’t give guidance, of course, but just at the high level, conceptually, we can talk about the OpEx 2023. If you look at Q4, you will see that the R&D spend is roughly $115 million. It is lighter than Q3, but Q3 of course, included $100 million for the PRV. Going forward, I would expect that the Q4 number to increase — to be flat or to increase by inflation for the rest of the year by quarter. For SG&A, if you look at the Q4 number of around $140 million a little bit below. But if you think about what’s going to happen in 2023, we’re going to have a second launch in the U.S. for subcu, but there will not be material increases with that, but there will be marketing spend for the second campaign.

Page 9 of 10