Q1 2023 argenx SE Earnings Call

Your next question comes from the line of <unk> Sonya from Guggenheim. Your line is open.

Hi, Thank you for taking my question.

Question on the CIB piece study are you willing to share the relative mix of the so.

Basically the baseline of BC IDP patients how that might look relative to the 40 patient baseline that you had shared with you.

Can't answer it I wanted to ask about Europe , especially as it relates to the gmg launch like what are some of the major hurdles for you to really accelerate the uptake in Europe similar to what Youre seeing in the U S. Thank you so much.

The style of the house.

Thank you Tim.

Say, what we are in pricing and reimbursement discussions in more than 10 countries, but basically all European countries. We are in various stages of that we hope to conclude some of those processes before the end of the year, but really from a planning perspective, we see more Australia 24 launches and that is basically the main hurdle.

And back with <unk>.

Unmet need is there and the initial feedback from the payers and physicians and the patients where we have it is really positive and we look forward to a successful launches, but it will take time to get there.

Okay.

Your next question comes from the line of of cash to worry from Jefferies. Your line is open.

Hey, thanks, so much so just number one any color on exactly when you hit the 88 events for CDP and on the placebo arm.

What signals are you seeing internally that gives you confidence that placebos behaving kind of like the patch study did and not.

Not a kind of bearish scenario, where relapsed rates are trending more in the 40% to 50% range. Thank you.

Thank you akash, thanks for being with US today. So we are not giving any more granularity on exactly when these events happen.

I also don't think Thats important I think the most important fact is that we now evident and from <unk> actually been in control of the final steps in the process.

As a matter of any data so we will need to wait for placebo data until we see the data and we've been ready of course to presenting to all of you. So stay tuned we will be talking about placebo during the topline release. Thank you.

Your next question comes from the line of Thomas Smith from SBB Security. Your line is open.

Hey, guys. Good morning, Thanks for taking the questions.

Total thank you for the question I think the public on the fact that we are going to launch with the kind of first generation sub Q.

More of that turnover.

Fast and are in the process so multiple generations in the works.

Just for <unk>, but also be applicable to other pipeline assets.

Thank you.

Your next question comes from the line of Danielle Brill from Raymond James Your line is open.

Hi, guys. Good morning, Thank you for that question.

So it sounds like you're launching the <unk> before we have top line.

Data so I'm just curious how that impacts your thinking on pricing strategy for the Sun care.

Okay.

Yes.

Hey, Danielle thanks for being with US today and thank you for the pricing question typically we don't give any color on pricing until the date of launch. So I would just relative to have a few months patients to C&I Harvey launching.

The companies of course to give you transparency on those.

The day of launch Okay. So far.

And with us.

Okay.

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

Great. Thanks for the CIB trial.

Most important to achieve for that trial to be considered a success.

Yeah.

Hey, Joe Thanks for being with Us.

The way, we have been calibrating expectations, despite facing our audience back to the historical <unk>.

The type of data coming out of the <unk> study, which would put us in a position to effectively compete with <unk>. So we would be triangulating towards kind of 50%.

Our response in stage a.

Zinc and effect size of 20% to 30% difference between active and placebo in stage B I think that would put us in a position to effectively compete that is the AG thats the comparable efficacy roughly speaking.

Our quarter to now.

Our product will also be judged by service split.

Just the benefit also the risk.

3200, 30 seconds, those injection compared to a lot, which is basically organized around the infusion chair. So I hope this answers to your questions.

Your next question comes from the line of Alex Thomson from Stifel. Your line is open.

Great. Thanks for taking my question I was hoping maybe you could provide a little bit more details around sort of the current patient mix in the U S. On depth guard can you talk a little bit about the proportion of patients that are on drugs that are <unk> naive and then maybe if you could comment on whether youre seeing any meaningful off label use either in sort of non acetylcholine receptor positive antibody patients.

Or in other indications thanks.

Yes. This is Karen I can provide some of that.

And as what we've seen since launch is that we've been progressively getting moving up early align patient so more momentum.

After <unk> and IFC.

Terms of the.

Around 50% to 55% of our patients currently upcoming from IV.

As I mentioned earlier, our strategy is to continue to move earlier in the treatment paradigm in terms of off label. We don't track that data, we don't support off label use of the product through PSP, but we done from what we understand we don't see significant off label use.

Great. Thanks.

Your next question comes from the line of Allison <unk> from Piper Sandler Your line is open.

Hi, good morning, and thank you for taking my questions because it's a commercial question on <unk>.

Could you comment on any first quarter seasonal effects you saw.

Payer resets every verification of benefits was that a meaningful factor in the quarter.

At least in the U S and any any color there would be helpful. Thanks.

Yes, thanks for the question.

As you all well know we have very strong payer access.

Well, they've got and so what we saw with some.

On therapy to February or March. So it was really more of a push by a month or two rather than anything more.

I have a.

Question on CDP it sort of.

A two part question interrelated. The first one can you give us a little bit of a sense I mean that you only really stopped recruiting.

Back in February so so it sounds to us like you probably ended up recruiting close to 180 patients will be upper end of the study.

Why that's going to take a little bit longer than normal. Thank you.

The rollover mechanics are relatively complicated in that sense that a patient has an option to either go to the open label extension or not go over to the open of recession and they need to do some closeouts visits you need to collect so final information et cetera. So youll have that decision pork and the roads and it just involves channel corporately visits.

Data collection.

And basically that study is in the shape that you can see okay. We have all the data into lock the database and Kovytkino quality data top line data readouts.

Okay, I hope that makes sense. Thank you Ian.

Your next question comes from the line of Samantha Southern Cal from Citi. Your line is open.

Thank you very much for taking my question.

Hi.

Oh, you have and you're not.

Talking about the 180 quite.

And then here you aren't going to give any additional details on that at this time, maybe could you just talk about.

Hi, sorry, excuse me I have two.

Yes.

Your next question comes from the line of Myles Minter from William Blair. Your line is open.

Hey, Ross Thanks, Jeff. Thanks for the question. That's a great question. So the way you need to think about our agenda collaborations in the context of our <unk>.

<unk> partnered with expert partners externally to go after novel target Biology, and this is just an interesting immunology pathway, where we see utility in both our community and oncology and we think there is a real.

Exciting increasing probability of success by joining forces summit, two antibody powerhouses with complementary technology platforms and expertise.

And sale trends will evolve and advocate for the year in the U S and in the European region. Thanks.

And we expect that to continue as we move to earlier line patients and through the year.

Okay.

Hi team. This is suzanne thanks for taking my questions I was wondering beyond effort taking months for organics 117 in the upcoming mid 'twenty three data release.

Assuming of course, the molecule is going to work at element. So think of core volume the data a little bit talking about mid of the year as the first dose and dosing regimen cohorts, we've been aiming for a certain percentage of CPM inhibition.

I invite you to look at the column will be normalized per ton unit, you will actually see that the safety profile of this growth continues to be a very clean and in line with the adapt study itself. So I think the news of this post is outstanding.

Advance that more quickly.

Early align us there are some patients that might not want to move from an <unk> to an infusion from.

A subcutaneous option.

Logistics reasons for patient preference whatever it may be that we believe it opens up a whole new patient.

Opportunity for us in early line to have the opportunity to have either IV or subcutaneous.

Great. Thanks very much.

And this concludes today's conference call. We thank you for your participation today you may now disconnect.

Okay.

Hmm.

Okay.