argenx Q1 2023 Earnings Call Transcript

Quartr
Provided by Quartr
May 4, 2023

There are 14 speakers on the call.

Operator

Good morning. My name is Rob, and I will be your conference operator today. I would like to welcome everyone to the call. At this time, all lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer Thank you.

Operator

I'd like to introduce Beth Del Jocco, Vice President of Corporate Communications and Investor Relations. You may begin your conference.

Speaker 1

Thank you, operator. A press release was issued earlier today with our Q1 2023 financial results and a recent business update. This can be found on our website along with the presentation for today's webcast. Before we begin, I'd like to remind you on Slide 2 that forward looking Statements may be presented during this call. These may include statements about our future expectations, clinical developments, regulatory timelines, The potential success of our product candidates, financial projections and upcoming milestones.

Speaker 1

Actual results may differ materially from those indicated by these statements. Argenx is not under any obligation to update statements regarding the future or to conform those statements in relation to actual results unless required by law. I'm joined on the call today by Tim Van Harameren, Chief Executive Officer Carl Gubitz, Chief Financial Officer and Karen Massey, Chief Operating Officer. I'll now turn the call over to Tim.

Speaker 2

Thank you, Beth, and welcome, everyone. Slide 3. I'm pleased to be here today to share another quarter of strong execution With our global Vistgard launch, we continue to deliver results, both in our ability to reach patients and drive revenue, But also with the progress we are making on the regulatory side. We recently announced regulatory approvals in Israel and the UK, Marking our 4th and 5th approvals globally and we expect more to follow later this year. This is a remarkable achievement from our global submission teams.

Speaker 2

We are preparing for additional regulatory milestones With the potential approval of subcuevgartigimab in the United States, our PDUFA date of June 2020 is fast approaching As to which we hope to have the broadest TMG offering for patients both with an IV infusion and a simple subcutaneous injection. We know that gaining traction in early line patients will be important for the continued trajectory of our launch And the approval of InstepQ products may help us achieve this. I was able to attend the AAN meeting last week Well, we had a significant presence demonstrating our long standing commitment to the neurology community. We had 6 aspects accepted for presentation, including new data from the ADAPT Opalabel extension studies, Highlighting the consistent efficacy and safety profile of both IV and subcu atcategumab. More importantly, we were able to connect with leading neurologists, many who are using gift cards in their practices.

Speaker 2

Slide 4. When we first started development in gMG, we made a commitment to the patient community. We had listened to the challenges they faced with long diagnosis journeys and significant disease burden And wanted to create an entirely new standard of treatment elevating the expectations of physicians and patients on what Bell Control means. It was clear from our interactions at AAN that we are achieving this with this guide. We heard stories of patients Where VIVKA had a transformational impact and it felt like we had come full circle in honoring that initial commitment.

Speaker 2

Beyond the upcoming subcutaneous approval decision, we also have a busy upcoming quarter and remainder of the year with our pipeline. We continue to expect 5 data readouts across efgartigimab And argenx117, all of which will showcase the depth of potential within our immunology programs. Slide 5. Firstly, efgartigimod. Since our last call, we crossed the 88 event mark In the ADHEAR trial and are making progress towards the readout of top line results in CIDP, Reaching 88 events does not mark the end of the trial and the team still has to gather final data points from patients And complete some mechanics associated with rollover to the open label expansion study.

Speaker 2

This is an important readout for us And for the CIDP community, we want to put ourselves in the best position to bring in new innovation to CIDP patients as quickly as possible. As part of this, we will give our team sufficient time to close the trial and review the data in a high quality way, Which is why we now expect top line data in July. We also have exciting updates from the ADVANCE subcu and ADDRESS trials, Both of which have completed enrollment. This puts us firmly on track to have top line results in immune thrombocytopenia And some figures in the Q4 of this year. All of this sets us up to have multiple potential approvals over the

Speaker 3

next 2

Speaker 2

years, Advancing us towards achieving our 2025 vision of reaching autoimmune patients globally across our franchises. With ITP, this process will start in Japan in the middle of this year, and we expect to file the dossier for approval Based on the IV data, the rest of our rasgastimab programs remain on track and we expect to start several trials in new indications And before the initial results in post COVID POTS, buenospensigoid, myositis, Children's and vendor listing property all before the end of 2024. Slide 6. We also expect the 1st clinical efficacy data on ARGX-one hundred and seventeen in the middle of this year From the Phase 2 trial in multifocal motor neuropathy, we have a couple of objectives with the first cohort of 9 patients. We want to confirm the safety profile we observed in the Phase 1 healthy volunteer study, but now in MMN patients.

Speaker 2

We also want to understand the extent of complement blockade we can achieve with the initial cohort 1 dose scheme. Based on what we learned from that And the corresponding efficacy results, we will start to build out a PKPD model that will ultimately be used To identify our Phase 3 dose level. And lastly, we want to understand whether we can maintain or even improve efficacy scores We're switching from IVIG to ARGX-one hundred and seventeen. Through the trial, while a small initial sample We'll provide us with a lot of information. Slide 7.

Speaker 2

And last within our wholly owned pipeline, ARGX-one hundred and nineteen. We started the Phase 1 trial earlier this year and will be evaluating single and multiple ascending doses. In the higher dose levels, we will also evaluate responses in a congenital myasthenic syndrome patient cohort. Before I turn the call to Carl, I want to take a moment to thank our teams. The feedback we hear from physicians at AAN It's just a small window into the achievements over the last year, particularly from our field teams who engage from climate positions.

Speaker 2

We are over one year into our GMG launch and are preparing for the 2nd launch with subcu. This is still just the beginning We hope to achieve our mission to transform auto Unity. With that, I will turn the call over to Carlo to talk about our financial results.

Speaker 4

Thank you, Tim. Our Q1 2023 financial results Are detailed in our press release from this morning, I will only highlight the key points here on Slides 89. We generated $230,000,000 in total revenues for the Q1, which includes $280,000,000 in global net product revenues, $1,000,000 in collaboration revenues and $11,000,000 in other operating income. Cost of sales for the quarter were 18,000,000 When looking at the breakdown of our global product sales, you can see that $196,000,000 was from the U. S, $10,000,000 from Japan $12,000,000 from Europe and our distributor markets.

Speaker 4

With Europe, The large majority of revenues comes from Germany, and this will be the case for the rest of the year, even with the price

Speaker 2

adjustment, which will take place through the

Speaker 4

AMLOP process. The Which will take place through the AMLOG process. Recall that we will land on our negotiated price in September, But we'll start to recognize revenue at that expected new price 6 months ahead of that, so effectively March 2023. Our R and D expenses for the Q1 were approximately $166,000,000 and can mainly be attributed The external research and development expenses and personnel expenses incurred from clinical development activities. Our SG and A expenses for the Q1 were $149,000,000 and was mainly driven by professional and marketing fees Linked to the commercialization of Vivcard in the U.

Speaker 4

S, Japan and the EU. We ended the quarter with $2,000,000,000 in cash, cash equivalents and current financial assets based on our current operating plans Under projected 2023 cash burn of approximately $500,000,000 we expect our existing cash, Cash equivalents and current financial assets, together with anticipated future product revenue to fund the company to profitability. You can find additional details behind these numbers in the press release we issued this morning. I'll now hand the call to Karen for a commercial update.

Speaker 1

Thank you, Carl. Slide 10. It's been an exciting 1st 6 weeks for me at argenx and I'm delighted to be working with an exceptional group of colleagues who are creating value quarter over quarter, not just commercially, but truly across the business. When I first made the decision to join Argenx, it was the culture that initially drew me in and the innovative science and patient driven mission that made me realize the uniqueness of the company and of the opportunity. I spent most of the time in the last 6 weeks meeting the team, listening to the conversations among them and learning.

Speaker 1

I've witnessed a team of people who are talented, passionate and engaged. They are at the core of our successful launch I believe that the strategies that were developed at the beginning of the launch are the right ones And now we have the opportunity to expand further on this. We need to optimize how we engage with our key stakeholders to continue to bring value to patients and society. I look forward to building on these achievements together with the team as we expand the Ziff Guard opportunity into new geographies and new patient population. Turning now to a review of our recent commercial progress with our global launch, Slide 11.

Speaker 1

As Carl mentioned, we generated $218,000,000 in global net product revenues this quarter, We showed the continued demand we are getting from physicians and patients. The unmet need in gMG is significant. And with VIVGAS, our 1st in class FcRn blocker, we have been able to reframe expectations of what a therapy should offer to patients. This has been a driving force of the consistent growth we see. I also had the opportunity to attend AAN last week And one of my key observations is that the value proposition of this guide is clear.

Speaker 1

The data we generated from Adapt are Playing out in the real world in a very consistent way, especially in the ADAPT like patient population. The commercial and medical teams last year did an amazing job establishing the product as a new treatment option for gMG. The opportunity in there is to entrench it as a go to therapy among neurologists. There is nothing more valuable than physician experience to A physician having direct positive experience is much more powerful than the impact of reading published data. One story I heard from a physician was so rewarding, someone who had had early experience with ZivGuard, but hadn't moved up the adoption curve yet.

Speaker 1

Only took one patient with a transformational response to change their perspective, pushing the doctor to now use Zivdart in the earlier adult like population After ISTs or even restinom. The patients said they are experiencing a new normal that they didn't realize was possible. This is what we want to achieve when we talk about changing expectations. We also want to build on the momentum we established amongst patients, Finding more and different ways to reach patients, especially those earlier in line of therapy. We see more of our patients Coming to VIVGOT directly from ISTs and oral and continuing to shift to early aligned patients will be instrumental for our growth trajectory.

Speaker 1

Of course, this takes time. It means further challenging physician inertia and the disconnect between patients and physicians on what Well controlled could mean. We hope that the subcu approval will be a potential momentum driver for this shift. We are now just 6 weeks away from our subcu seducer date and we are busy preparing for our second potential product launch. We believe the most powerful way to create value is through innovation and the most powerful offering to the gMG community is to provide more choice.

Speaker 1

For us, this means further individualizing GMV treatment, not only with the dosing schedule, but also by offering both an IV and subcu option Capture the broadest number of patients. A subcu option may also serve us well from a payer perspective. Our engagement with payers in the U. S. Was a success driver for the Big DART launch and we will focus again on early conversations centered on the value we can create for patients and society.

Speaker 1

Even with our proactive strategy, we expect to navigate We are planning to launch our subcu products in the U. S, but we are also filed in both Europe and Japan. By early 2024, we hope to have both IV and subcu Vistar products approved across all three priority regions, And we'll be working in the background on a next generation presentation with a prefilled syringe. I want to leave plenty of time to your questions. So before we close the call, I'll quickly touch on our global expansion because we continue to expect new approval through the end of this year.

Speaker 1

Slide 12. We received notification last week from the Ministry of Health in Israel that together with our partner Medicine Pharma, we received approval of DUGAT for gMG. This marks the 5th approval in less than 18 months, an achievement that is truly remarkable for a first time launch company. When I talk about being impressed by the commitment to patients and the team's ability to execute and deliver on its goal, this is a perfect example of that It makes me proud to be part of such a dedicated team. We also received approval in the U.

Speaker 1

K. Earlier in the quarter And are already in price negotiations as we aim for late 'twenty three, early 'twenty four launch. Across Europe and the U. K, we are now in Pricing and reimbursement discussions in more than 10 countries. So from a revenue perspective, Germany will be the primary driver this year, even with the price adjustments that Carl mentioned.

Speaker 1

We are also on track in both China and Canada to receive approval decisions by the end of the year, which would mark the 6th and 7th approval for VipGard. I'm going to close by reiterating how excited I am to be part of the argenx team. We have a lot to accomplish in the months ahead, but it is clear that we are just scratching the surface with the vastness of our opportunity, both with ZiffDOT as well as our future programs. Successful biotech companies are built on a foundation of innovative science, great talent and strong culture. And at argenx, we have all 3.

Speaker 1

I'm so inspired by what has already experienced and I'm ready to make the most of the opportunity before us, positioning argenx for future growth. And with that, I'll now turn the call back to Tim for closing remarks.

Speaker 2

Thanks, Karen. Slide 13. Sitting here in May, We still have many milestones ahead of us this year, which for us means that we have the opportunity to reach more patients, Advance our clinical programs, invest in our strong science and innovate across every corner of the company To create more value for our stakeholders. And we're not stopping here. Our new term data readouts The first of many important stepping stones to unlock the full potential of our differentiated immunology pipeline programs And we look forward to communicating on those in the coming months.

Speaker 2

The value we are creating today is laying a strong foundation for the long term As we build a global integrated multi asset immunology company focused on transforming the future for autoimmune patients. Thank you for your time today. I would now like to open the call to your questions.

Operator

Your first question comes from the line of Derek Akyla from Wells Fargo. Your line is open.

Speaker 5

Hi, everyone, and congrats on the quarter and a great Appreciate you taking my questions. So just recognizing that we're 5 quarters into the VIVGART launch in MG and things are going very well, I guess What are some of the factors that are keeping you from putting out official sales guidance?

Speaker 2

Eric, it's great to have you with us today and thank you for your question. This is one for my colleague, right. Karl, would you mind taking this question?

Speaker 3

Thank you, Tim. Thank you, Derek. Yes, we will not be providing guidance this year. There are still too many variables. We are only 1 year into the launch.

Speaker 3

We have benchmarked also and we don't see any reason to do it this year. We will, of course, stay close to our analysts and make sure that our launch is well understood. Thank you,

Speaker 5

Thanks. Maybe just pushing a little bit, I guess you said the key variables, that's kind of the question that I'm asking is like what are those variables that are most important to putting out sales guidance?

Speaker 3

Those variables include, of course, the subcu launch. It includes the pricing and reimbursement Discussions which are ongoing in the various European markets. We don't know when they will conclude. Those variables include the German price. We don't have any price in Europe yet.

Speaker 3

We're still negotiating the German price and that will be our first price. The China launch, which of Of course, it can be a big variable. There's some uncertainty around that, Canada and then also the speed of which we will continue to move into the earlier lines in the U.

Operator

Your next question comes from the line of Tazeen Ahmad from Bank of America. Your line is open.

Speaker 6

Hi, good morning. Thank you for taking my question. Maybe just a little bit more color. Tim, I know you had given us An explanation on the prep's remarks about the push to July for the top line readout. But since you have had those 88 events already And it's still early May.

Speaker 1

Can you give us a little bit more color on why you think you will need until July to get us that top level data? Thank you.

Speaker 2

This is Alina. Looking forward to being at the conference next week. So the good news is we have 8, 8 events I think the uncertainty about events is out of the system. So from now on, it's just a linear trajectory, right, to data readout. It's not because we have 88 events that the study is finished.

Speaker 2

So we're still dealing with the mechanics of unwinding the study. So we enrolling all the patients Or we're basically getting the patients then out of the study. So there are a number of steps to be taken to database lock. And then after database lock, we can go pretty fast to top line data readout. So we're working very hard.

Speaker 2

The team is working very hard, but of course this is such an important study that we also want to allow the team to do quality work. So we're not going to put Any unnecessary time pressure on that. Thanks for the question. Thank you.

Operator

Your next question comes from the line of rahansh Sharma from Goldman Sachs, your line is open.

Speaker 5

Hi, thanks for the question. Rajan Sharma from Goldman Sachs. Maybe one for Karen. Just thinking about the dynamics Between IV and subcutaneous at cartigimod and myasthenia gravis, it'd be good to get your thoughts on that and how you think it may play out in the long term?

Speaker 1

Yes. Thanks for the question. Happy to talk about it. We're excited to be on track So the subcutaneous launch with a PDUFA date of June 20. You heard from Carl and also earlier, the big focus And the opportunity for us is with early aligned patients with VIVVAT.

Speaker 1

And we believe that there's an opportunity with the subcutaneous to really help us open up more early aligned patients. And the reason for that is because it aligns with our strategy of offering choice To prescribers and to patients. So we can see that there might be, for prescribers, different reasons, Potentially in the community that they might prefer, maybe there's infusion capacity issues, they might prefer the subcutaneous option. And for patients depending on their lifestyle, depending on their payer coverage. So the fact that we're offering options, aligns with our strategy Similar to the individualized dosing.

Speaker 1

We're not providing guidance or a forecast of how the business mix will evolve between IV and subcutaneous, But we will be focusing on keeping the boat on the market and providing that choice to patients and prescribers.

Operator

Your next question comes from the line of Yatin Senya from Guggenheim. Your line is open.

Speaker 7

Hi. Thank you for taking my question. Question on the CIDP study, are you willing to share the relative mix of the So basically the baseline of the CIDP patient, how that might look relative to the first 40 patient baseline That you had shared. If you can answer it, I wanted to ask about Europe, especially as it relates to the gMG noise. Like what are some of the major hurdles For you to really accelerate the uptake in Europe similar to what you're seeing in the U.

Speaker 7

S? Thank you so much.

Speaker 2

Thank you, Yatin, for your quick questions. So on the first one, the answer is simple. I think we'll need to wait for the top line data release because We don't have that information at this point in time. And that's assured that in the typical style of the house, we will release top line data such There will be sufficient clarity about the context and the meaning of the data. With regards to hurdles to the European launch, Maybe, Karl, this is a question which you'll be comfortable to take.

Speaker 3

Yes. Thank you, Tim. I would say that the main hurdles, of course, is pricing and reimbursement processes. We have only launched in Germany and that is through the AMLOG process where we are throughout the 12 months we are negotiating the price. That leads to some positions in Germany have a natural conservatism as we go through this process.

Speaker 3

But that said, if we look at Germany, the unmet need is definitely there. The feedback we get back from physicians and patients are really positive. In terms of the rest of Europe, we say what we are imposing and reimbursement discussions in more than 10 countries, but basically also European countries. We are in various We hope to conclude some of those processes before the end of the year. But really, from a planning perspective, We see it more as 2024 launches, and that is basically the main hurdle.

Speaker 3

I just want to end back with the unmet need is there and the initial Feedback from the payers and their physicians and the patients where we have it is really positive, and we look forward to successful launches, but it will take time to get there.

Operator

Your next question comes from the line of Akash Tewari from Jefferies. Your line is open.

Speaker 8

Hey, thanks so much. So just number 1, any color on exactly when you hit the 88 events for CIDP? And on the placebo arm, what signals are you seeing internally that gives you confidence that placebos behaving kind of like the PAT study did And not a kind of bearish scenario where relapse rates are trending more in the 40% to 50% range. Thank you.

Speaker 2

Hey, thank you, Akash. Thanks for being with us today. So we're not giving any more granularity on exactly when these 888 events happen. I also don't think that's important. I think the most important fact is that we now have them and from now actually we're in control of the final steps in the process.

Speaker 2

We're not aware of any data. So we will need to wait for placebo data until we see the data and we then ready of course to present them to all of you. So Stay tuned. We will be talking about placebo during the top line release. Thank you.

Operator

Your next question comes from the line of Thomas Smith from SVB Securities. Your line is open.

Speaker 9

Hey, guys. Good morning. Thanks for taking the questions. You mentioned work going on in the background on a next gen subcutaneous presentation of I was just wondering if you could provide a little bit more details. Is this still using the ENHANZE enabled technology?

Speaker 9

And maybe if you could provide An update on the Electrify collaboration that would be super helpful. Thanks.

Speaker 2

Yes, Thomas, thank you for the question. I think we've doubled it on the fact that We're going to launch with a kind of 1st generation subcu, which is a pull up product from the vial like so many other product executions look. But then we are, of course, diligently working on a pre filled syringe. So that is the next generation that you're alluding to. You know that Discovery likes to plan for the long haul.

Speaker 2

So we're working on multiple product presentations, including of course a few product presentations And that's where you have to contextualize the Electrify collaboration. More on that you know when we've more advanced in the process. So Multiple generations in the works, not just for Vivcard, but also be applicable to other pipeline assets. Thank you.

Operator

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

Speaker 1

Hi, guys. Good morning.

Speaker 6

Thank you for the question.

Speaker 1

So it sounds like you're launching the subcu before we have top line CIDP data. So I'm just curious how this impacts your thinking on pricing strategy for the sub

Speaker 2

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 encourage you to have a few months patience to see how we're launching and The commitment of the company is, of course, to give you transparency on positioning of the product and pricing at the day of launch, okay? So bear with us.

Operator

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

Speaker 3

Great. Thanks. For the CIDP trial, what's most important to achieve for the trial to be considered a success?

Speaker 2

Hey, John. Thanks for being with us. The way we have been calibrating expectations By taking our audience back to the historical IVIG registrational trials, what we have been talking about As you know, the type of data coming out of the HD study, which would put us in a position to effectively compete with IVIG. So We would be triangulating towards kind of 50% response in Stage A and I think an 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 with IVIG, that's a comparable efficacy, roughly speaking.

Speaker 2

You know, of course, that you know The product will also be judged by its risks. It's not just the benefit also the risks. I think we're offering a very safe and tolerable product. And then of course convenience, which will be a game changer comparing a 32 and 120 seconds cell injection Compared to a life which is basically organized around the infusion shares. So I hope this answers your question.

Speaker 2

Thank you.

Operator

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

Speaker 8

Hey, great. Thanks for taking my question.

Speaker 9

I was hoping maybe you could provide a little bit more details around sort of the current patient mix in the U. S. On VIVGAR. Can you talk a little bit about the proportion of patients that are on drugs that are IVIg naive? And then maybe if you could comment on whether you're seeing any meaningful Off label use either in sort of non acetylcholine receptor positive antibody patients or in other indications.

Speaker 9

Thanks.

Speaker 1

Yes, this is Karen. I can provide some of those answers. What we've seen since launch We've been progressively getting moving up to earlier Lyme patients. So more momentum After orals and ISTs. In terms of the IVIG, around 50% to 55% of our patients Currently are coming from IVIG.

Speaker 1

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 don't from what we understand, we don't see significant off label use.

Speaker 9

Great. Thanks.

Operator

Your next question comes from the line of Allison Brasil from Piper Sandler. Your line is open.

Speaker 6

Hi, good morning and thank you for taking my questions. So just a commercial question on Vivintaert. Could you comment on any Q1 seasonal effects you saw With payer resets or re verification of benefits, was that a meaningful factor in the quarter, at least in the U. S? Any color there would be helpful.

Speaker 1

Thanks for the question. So as with other products, we did see Patients in January. As you all well know, we have very strong payer access for VIVGUARD. And so what we saw was None slowdown in January, but really those patients were back on therapy for February March. So it was really more of a push

Operator

And your next question comes from the line of Yaron Werber from Cowen. Your line is open.

Speaker 10

Great. I have a question on CIDP, sort of A 2 part question that's 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 it sounds to us that you probably ended up recruiting close to 180 patients with the upper end of the study. Is that correct? And then secondly, when you're talking about just before you're able to lock the database And moving patients to the open label extension, how does that work?

Speaker 10

It's not it doesn't happen automatically at week 48 You're referring to really now taking all the placebo patients and moving them over whatever remaining patients there. I'm just trying to understand You know why that's going to take a little bit longer than normal? Thank you.

Speaker 2

Yes. Thank you, Yaron. Thank you for the question. So You correctly call out that we continue to enroll patients to the trial even if we thought that we had sufficient patients in Stage B To ultimately hit the 88 events. So you will see the final details of the patients we effectively enrolled to the run-in Stage A and Stage B When we do the top line data readouts, the rollover mechanics are relatively complicated in that sense that a patient has an option To either go to the whole label extension or not go over to the whole label extension and then you need to do some close out visits, you need to collect some final information, etcetera.

Speaker 2

So you have the decision fork in the road and it just involves you know, confirmed visits, data collection Basically, that study is in the shape as you can see, okay, we have all the data into HOKA database and go with quality data to a top line data readouts. Okay. I hope that makes sense. Thank you, Eun.

Operator

Your next question comes from the line of Samantha Simonskyou from Citi, your line is open.

Speaker 6

Thank you very much for taking your question. So you have You're not talking about the 180 patients that you're enrolling in EDGAR. You aren't going to give any additional details on that at this time. Maybe could you just talk about

Speaker 1

sorry, excuse me, I have to get off on here.

Speaker 2

This will be an opportunity for me to finish up On the other question, once there is an event happening, of course, as a patient, you can make the decision to roll over For basically exit the study, so you don't have to be 48 weeks in the study. It is an event driven trial, not a time driven trial. And I hope that That answers also the question which we have from Citi. Let's move on. Thank you.

Operator

Your next question comes from the line of Myles Mentor from William Blair, your line is open.

Speaker 11

Thanks for taking the question. It's actually on the Genmab collaboration. Just curious as to how dedicated You are stepping into oncology in the joint venture. I know previously sort of out licensed an asset to AbbVie, but Just wondering whether that's a pillar outside of immunology or tangential to that that argenx is really dedicated to or is Genmab really the lead on that oncology Yes, and you're focusing on the immunology part of that deal. Thanks very much.

Speaker 2

Hey, Miles. Thanks for that question. It's a great question. So The way you need to think about our Genmab collaboration is in the context of our IIP program. We are externally focused.

Speaker 2

We'd like to partner with expert partners externally to go after novel type of biology. And this is just an interesting immunology pathway Well, we see utility in both autoimmunity and oncology. We think there's a real exciting Increase in probability of success by joining forces, I mean 2 antibody powerhouses with pretty complementary technology platforms and expertise. So we're having a go at this pathway. We will basically go in that fifty-fifty.

Speaker 2

We will share any investments and costs fifty-fifty and we will share any upside fifty-fifty. So whenever there is upside in oncology, we can share. Whenever there is upside in autoimmunity, we can share. So that's the gist of the collaboration more than anything else. Okay.

Speaker 2

Thank you for your question.

Operator

And your next question comes from the line of Neil Alexander from Deutsche Bank. Your line is open.

Speaker 5

Hi, guys. It's Neil Alexander from Deutsche Bank. It'd be good to get your views of how sale trends will evolve And as we get through the year in the U. S. And in the European regions.

Speaker 5

Thanks.

Speaker 1

Yes. This is Karen. I can comment on that. As Carl mentioned earlier, we won't be providing guidance. But in terms of the Friends, we've seen consistent growth and momentum in the U.

Speaker 1

S. Market, and we expect that to continue as we move to Early aligned patients and through the year. Carl already shared some thoughts on the European market. We're Pursuing pricing and reimbursement and so we think that will be a slower growth trajectory. It's also very important to note that we do have competition coming later in the year And so that will be a further unknown factor, but we're confident in our efficacy, safety and convenience profile But we can establish as those competitors come into the market.

Operator

And your next question comes from the line of Suzanne De from Kempen and Company. Your line is open.

Speaker 1

Hi, team. This is Suzanne. Thanks for taking my questions. I was wondering beyond efgartigimod for ARGX-one hundred and seventeen and the upcoming mid-twenty three Data release. Can you give some more granularity?

Speaker 1

I understood this is the 1st cohort readout. How many patients are that? How many are on drug and placebo? The doses that you're testing? And what other cohorts are there in this And then I have a follow-up, Octanev.

Speaker 2

That's great, Suzanne. It's an excellent question. Of course, AGX-one hundred and seventeen is a molecule we're very excited about. The way you have to think about the Phase II trial is the following. Nobody has any idea what level of C2 inhibition one needs to have a clinical effect in MMN patients.

Speaker 2

So what we're really trying to build is a PKPD model based on the Phase II data, which can reliably predict The Phase 3 dose in NMM, assuming of course the molecule is going to work in NMM. So think of cohort 1, the data we will be talking about Mid of the year as the 1st dose and dosing regimen cohort where we're aiming for a certain percentage of C2 inhibition. So we will be talking about 9 patients in total where we will basically have an idea for that type of C2 inhibition What clinical efficacy you can expect based on those data we have an option to either up the dose or lower the dose We then conclude the Phase II trial. Remember all MMN patients which we are realistically able to attract to the trial Or basically on IVIg. So this is again going to be kind of randomized trial design where we basically see The stable cadence on IVIg for these patients and then they get randomized after the run-in period either on ARGX-one hundred and seventeen or on placebo And we hope to see that we can keep these IVIg patients stable on ARGX-one hundred and seventeen, whilst of course you would expect The placebo patients do need V treatment after a while with IVIg.

Speaker 2

So that's the type of data we're going to talk about. You had a lot of questions.

Speaker 1

Yes, yes. Thanks a lot. That's very helpful. I just have one clarification question on the ADA Plus data presentation at AAM. There seem to have been more adverse events of Grade 3 or higher than before.

Speaker 1

Were those related to the COVID-nineteen infections or is there any other color you can give on this? Thanks.

Speaker 2

Thanks, of course, a caveat here, Susan. The open label extension is much longer, of course, than the randomized controlled trial. So the absolute number of events is going up Because you're just measuring over longer periods of time, I invite you to look at the column where we normalize per tonne unit. You will actually see that the safety profile of TypGuard continues to be very clean and in line with the ADAPT study itself. So I think the news of this post is outstanding.

Speaker 2

We have now multiple years of experience for GytGard, by the way not just in myasthenia gravis, But across many indications and the safety profile is consistent and encouraging, I think this is setting a whole new standard in terms of benefit risk profile In the severe autoimmune space. Thank you.

Speaker 1

Got it. Thanks.

Operator

And your next question comes from the line of Trevor Allred from Oppenheimer. Your line is open.

Speaker 10

Hey, thanks for taking the question. I just wanted to ask, so Tepes had a miss earlier just a few days ago. I wanted to see if you

Speaker 7

had any updated thoughts on

Speaker 10

the opportunity there and where Ethkar Tygabond fits in. Thanks.

Speaker 2

Perfect. We don't feel a bit sufficiently informed to talk about sales dynamics behind the Bezla. So I think this would be a question that's asked to Horizon. We repeat our conviction in the indication And Aviso, we selected that indication for VIVV guidance based on solid biology understanding and then of course the feasibility of learning clinical trials And the remaining unmet medical needs. Thank you for the question.

Operator

Your next question comes from the line of Douglas Tsao from HCW. Your line is open.

Speaker 8

Hi, good morning. Thanks for taking the questions and congrats on the progress, Tim. So maybe just for 117 as well as 119. I'm just curious because you've identified, we should have named Three indications for 117. You've sort of noted a couple potential ones for 119.

Speaker 8

How quickly after those initial studies do you think You might ramp into other indications and I say that just because with efgartigimod, we very quickly went from MG to a full pipeline of over double digit number of ongoing trials. And so do you see the same potential for those assets? And And do we think that, that Cartagena represents a roadmap for how quickly we might see the development programs for those assets expand?

Speaker 2

Thank you. Thank you, Blake. I appreciate your question. So you're right. When we select pipeline assets, we love to go for novel biology.

Speaker 2

We like to do that with what we think will ultimately be best in class antibody molecules and we like optionality. So we love molecules which can play in multiple indications. What ultimately the number of indications is going to be for our GENX-one hundred and seventeen and 119 we do not know yet. We think there is sufficient opportunity in front of us. But you know that we like to march based on conviction on the biology.

Speaker 2

So rest assured that argenx is doing its homework From a policy point of view, on opportunity above and beyond the indications we mentioned and we will inform you when we see sufficient ground to expand beyond the initial indications. Thanks for the question.

Operator

Your next question comes from the line of Joon Lee from Truist Securities. Your line is open.

Speaker 5

Hey, congrats on the quarter and thanks for taking our questions. For the planned TEP trial, it's sort of interesting to consider the possibility that Targeting FcRn could address not just the ocular manifestations, but also the systemic manifestations of hypothyroidism. Along that line, would you consider an endpoint other than proptosis for possibly a broader label? And as a follow-up, is there any data out there pointing How much IGT reduction you would need to have a clinical impact on proptosis? Thank you.

Speaker 2

Yes. Thank you, Jude, for the question. I'd love to answer it that the commitment we made during the JPMorgan conference was that clinical trial design details We'll be disclosed when the study will go online on clinicaltrials.gov. So I encourage us to be a little bit patient and then we can talk about primary, secondary endpoints, Inclusion, exclusion criteria, so we will be transparent there. It's just too early to talk about it.

Speaker 2

In terms of IgG reduction required To have a clinical meaningful effect in that patient, you know that we typically like to triangulate by a plasma exchange or unabsorption data. We also believe that some of the competitive data in the siren class constitute an interesting data point to triangulate it. So You know that with Viparct we achieved a comparable IgG level reduction as with plasma exchange and we think that will be sufficient to have a market impact in TD patients.

Operator

And your next question comes from the line of Charles Pittman from Barclays. Your line is open.

Speaker 12

Hi, thanks very much for taking my question. I've got a question on just MG and whether or not you could give us any details on the number of new patients that were accrued in 1Q versus Retreatments,

Speaker 8

whether you can

Speaker 12

give us any insight on the discontinuation rate of these patients now? And then maybe just a quick follow-up, if I'm not sure you'll give us much detail on this, but on the German pricing negotiations you have to start, how much is that likely to be? Are there any benchmarks that

Speaker 2

we should be looking at when we're

Speaker 12

considering Thank you.

Speaker 2

Charles, I'll give the first question to Carl on patient numbers and what is the formal line there. And then on this continuation, I will give the floor to Perin. And then maybe Karl, you also have to take the question on any benchmarks for Negotiated prices under the MLOC process in Germany.

Speaker 3

Okay. Thank you, Tim. On patient numbers, so thank you for the question, but we are not going to give patient numbers now. We do say that the launch is consistent, and we believe that the revenue number will be there to guide you. So we're not going to get into more details now.

Speaker 3

In terms of the German negotiations, we are, of course, at a very sensitive stage All the negotiations, we're not going to provide any comments. So please bear with us. We will, of course, start accruing Well, the difference between the old price and the new price effective March, I. E. You will see an impact on total revenues in Europe, I.

Speaker 3

E. Germany going down. But we're not going to provide any details due to the sensitivity and it will all be disclosed in September When the negotiations conclude. Thank you for the question.

Speaker 1

Thanks, Karl. And on the discontinuation rate, I would say it's too early for us to share any numbers. The data is still maturing. But it's about what you would About what we would expect at this point in launch from what we've seen. One important factor to remember is that Early on in the launch, we were getting more refractory patients.

Speaker 1

We've moved and are gaining momentum in the earlier Lyme patients And the discontinuation rate will reflect that as we move forward.

Operator

Thanks. And your final question comes from the line of Simon Baker from Redburn. Your line is open.

Speaker 13

Thank you for taking my question. Another one on Zivkart in M Chip. As I understand it, the only barrier to Early line usage is physician awareness. So I wonder if you could give us an idea of the rate at which you think Physician awareness will drive earlier line usage at a greater extent. The active efforts you're doing to Advance that more quickly and the importance of the subcutaneous formulation in driving earlier line usage.

Speaker 13

Thanks so much.

Speaker 1

Yes. Thanks for the question. It's a really good one. So I would say that during, of course, the 1st year of launch, A lot of the momentum that we gained, as you said, was through physicians gaining awareness and early experience with VIVGOT. And that what we've heard, the Feedback, I was at AAN last week and I heard this consistently, is that the experience and the early experience with DibGut reflects What they expected from the ADAPT study.

Speaker 1

And so actually what we see is the more experience as the physicians move from awareness To experience with Vivint, that's what's really driving the earlier line use and what's helping us with momentum In terms of moving earlier lines, so we expect that to continue as we continue You're executing on the launch as experience grows. In terms of the subcutaneous, that will help us. As I mentioned earlier, with earlier Lyme use, there are some patients that might not want to move from an oral to an infusion. There are some prescribers who might Prepare a subcutaneous options for logistics reasons, for patient preference, whatever it may be. So we believe it opens up a whole new patient Opportunity for us in the early line to have the opportunity to have either IV or subcutaneous.

Speaker 13

Great. Thanks very much.

Operator

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

Remove Ads
Powered by Quartr
Earnings Conference Call
argenx Q1 2023
00:00 / 00:00
Remove Ads