argenx SE (ARGX) Earnings Call Transcript & Summary

Good morning, and good afternoon. I'm James Gordon, JPMorgan European farmland biotech analyst. And today, kicking off the JPMorgan Healthcare Conference from the European side, I have the pleasure of introducing the argenx presentation and Q&A. So argenx CEO, Tim Van Hauwermeiren joining us, and it's an exciting time to talk to the company following FDA approval of Vyvgart for MG late last year. So really looking forward to the presentation. Thanks a lot. Over to you, Tim.

Thank you, James, and good morning and good afternoon, ladies and gentlemen. A very warm welcome to this argenx presentation. During the next 20 minutes, I will share our excitement about the year 2022, which is going to be an incredible year for us. We will see a great cadence of commercial Vyvgart launches. We will see numerous clinical catalysts and we will show how we continue to build a world-class product pipeline. We will discuss how we realize our innovation mission across the value chain. And yet this is just the beginning. We will talk about our steep value creation path between now and 2025, which is a path bringing us to being a global immunology powerhouse. Slide #2. We ended 2021 with the FDA approval of Vyvgart for generalized MG in adult patients who are anti-acetylcholine receptor antibody positive. This approval came in as planned, and we are pleased with the strong label we got, which reflects the strength of our drug as demonstrated in the ADAPT trial. Its safety profile comparable to placebo, full-dosing flexibility and a very broad patient population we can treat. We were prepared for this approval. And I am pleased to inform you that the Vyvgart launch is happening whilst we speak. This is the beginning of a very exciting chapter in the history of our company. And I'm personally very proud of my team, which made this happen through literally thousands of hours of hard work and personal sacrifice. We know gMG patients are waiting and we are ready to honor our commitment to serve them. We believe Vyvgart will be nothing less than a true revolution in the way we think about MG, and how we treat MG. Slide #3. And how do you do that? Well, we're going to work with all 3 of our key stakeholders, patients, health care providers and the payers. Our strategic imperatives for the Vyvgart launch are as follows: empower patients to demand better, provide best-in-class patient support, ensure rapid health care provider adoption of Vyvgart and enable appropriate access. Slide #4. We have a very robust field team to read the estimated 7,700 neurologists who treat approximately 79% of all gMG patients. Our field team moved into action at the end of December, and we already have drug in the channel. We started to engage with health care professionals and have reached our first patients. The field team consists of 71 territory business managers, 10 thought leader liaisons, 16 medical research liaisons, 10 nurse case managers, 13 market access professionals and 10 field reimbursement managers. It is important for us to be able to meet patients where they are. This is why we create the options of infusion sites, home infusion and specialty pharma across the nation. Slide 5. This is going to be a global launch, and we're kicking it off here in the United States first. Next, we expect a decision by the Japanese authorities in the first quarter of this year in Europe during the second half of this year, anticipate filings in China and Israel. In addition, we announced we are establishing argenx Canada based on attractive business case for building out our own infrastructure. We have made a commitment to make Vyvgart broadly available to gMG patients and their communities, and that is exactly what we're going to do. Slide #6. [indiscernible] that we call it the Vyvgart launch, I want to home in on our mission as argenx. Our mission is innovation. It is our sole reason of existence. We can see that our understanding of immunology is increasing exponentially, redefining the way we understand serious diseases. Our opportunity to translate this understanding into innovation and bring this to patients is limitless, hence the infinity symbol on this slide. Slide #7. But our innovation mission does not stop at the bench. It only starts there. We innovate in our trial design, taking the interest of patients into account and seeking to document the value of our treatments as completely as possible. We also innovate the way we reach patients through patient-focused initiatives such as MG United, My Real World MG and the award-winning MG docuseries. Finally, we innovate the way we seek to align interest with payers, Vyvgart's individualized dosing reflects what the patients told as they prefer and aligns the interest of physicians and payers as well. Finally, the value-based agreements we started to install with payers reflects again how we seek to innovate in the way we can organize access to Vyvgart. Slide #8. The success formula behind our innovation is built from the principle of co-creation. The idea that 2 parties joined forces to create something which none of them individually could create just by themselves. More specifically, We, as Black Belt Antibody engineers teamed up with top-notch academic labs, which are working on breakthroughs in immunology. Together, we can create a type of innovation which can transform the way we think about the treatment of serious diseases. Interestingly, we are now creating a dynamic that after the [ bench to bet ] co-creation, we're now seeing the [ bet to bench ] work kicking in through the very same collaboration mechanism. This means we are uniquely positioned to change the way we understand disease biology, the pathways we play in and with the molecules we develop, we can actually redefine the way we think about these diseases and reclassify them based on molecular pathways instead of just clinical symptomatology. Slide #9. Here we see the co-creation formula in action. Efgartigimod was born out of groundbreaking immunology research performed by Dr. Sally Ward from UT Southwestern combined with top-notch antibody engineering. Efgartigimod is a human IgG1 FC-fragment engineered with our proprietary [indiscernible] and is uniquely designed to interfere with IgG recycling without affecting any other aspects of FcRn biology. This translates into a uniquely differentiated safety and efficacy profile for this first-in-class molecule. Slide 10. And gMG is just the beginning. Based on our proof-of-concept data in ITP and CIDP, we know efgartigimod has the right to be a true pipeline in a product opportunity. We are very methodological about how we add indications, each time starting from a solid biology rationale, proven feasibility of running clinical trials and the existence of a high unmet medical need. We prioritize indications which fit our franchises and are now adding kidney as a fourth franchise. This is setting up the company for an exciting cadence of additional commercial launches starting as of 2024. With positive data, we expect to launch in 4 new indications by 2024. This time, we're not adding 1, we're not adding 2, we're not adding 3 new indications. We're adding 4 indications, leveraging our strategic alliances with Zai Lab and IQVIA. I would like to call out lupus nephritis and membranous nephropathy, specifically as diseases where we seek to leverage the clear biology rationale, but also the clean safety profile of efgartigimod that means no impact on serum albumin levels and no downstream effects on lipid housekeeping. This is especially relevant in indications where kidney function is already impaired and where patients may suffer from lower serum albumin levels and elevated LDL and cholesterol levels. Slide 11. Taking this one step further, efgartigimod is actually a tool which will allow us to further our understanding of so many more autoimmune diseases and to reclassify them as being truly IgG-mediated diseases. It is in this context that I want to call out our new indications of Long COVID-Associated POTS and Sjogren's syndrome, where it were the experts themselves in the field, calling our attention to the evidence they gathered that these are true IgG-mediated diseases. Slide 12. Similar to efgartigimod, ARGX-117 is borne out of deep insights into complement biology and top-notch antibody engineering. It is an interesting point of intervention in the complement cascade, [indiscernible] and carefully selected based on the unique benefit risk rationale based on our knowledge from genetic knockout information in humans. [indiscernible] is sitting at the nexus of the classical and the lectin pathway and blocking C2 allows a blockade of both pathways without affecting the alternative pathway, which is important for protection against life-threatening infections. Importantly, the phenotype of C2 genetic deficiency shows minimal risk of infection and lupus. ARGX-117 is a unique sweeping antibody. It is designed to tightly bind the target C2 in circulation and to drop it off in the endosomal lysosomal degradation path was being recycled itself, escaping from the same degradation pathway. In this way, 1 ARGX-117 molecule can actively clear multiple C2 molecules, planning its unique PK/PD profile which is designed to enable infrequent subcu dosing. Again, similar to efgartigimod, we anticipated ARGX-117 has true pipeline and a product potential. Next to the MMN proof-of-concept study, which is actively enrolling, we have now added delayed graft function as a second proof-of-concept indication. This is based on a strong understanding of the fact that ischemia reperfusion injury is driven by both the classical and lectin pathway, this is demonstrated in kidney biopsies. And this is just the beginning. More indications to follow. On Slide 13, ARGX-119 is our newest molecule, which is gearing up for clinical development. It combines deep fundamental understanding of the neuromuscular junction, its structure and functioning in close collaboration with leading academics, professor [indiscernible] on the 1 hand, with our world-class antibody engineering on the other hand. ARGX-119 is designed to regain muscle function, which opens up a universe of opportunity in the neuromuscular space. Just imagine what such a mode of action could potentially achieve in diseases like myasthenia gravis, SMA or ALS. Slide 14. So where is this all leading to, where is this all taking us? Well, we are on our way to build a global, multi-franchise autoimmune portfolio. Looking at the indications, we are already addressing, we have an incredible opportunity right now, and we believe this is just the beginning. By the end of 2022, we will be active in clinical development in 12 high-value autoimmune indications across 4 therapeutic franchises. With our neuromuscular franchise actually becoming a true company in a company, and we are reaching patients globally. This is how we build a global successful, independent immunology powerhouse. On Slide 15. This is our argenx 2025 vision. By 2025, we seek to be a key player in a global autoimmune market which has surpassed value of USD 150 billion. Efgartigimod will be made available globally. We will enjoy vibrant neuromuscular, heme skin and kidney franchises. Efgartigimod will play in 15 indications in clinical development or commercial. ARGX-117 will be multiple late-stage clinical trials. ARGX-119 will have demonstrated clinical proof of concept and we will continue to create new assets from our immunology innovation program. Slide 16 and my last slide. Dear shareholders, dear investors, our 2025 vision is bold, but I know we can do it. We have the molecules to make it happen. We have an experienced team to make it happen. But most of all, the entire company has the determination to make it happen, to do the unthinkable, to step in the footsteps of the Argonauts, which were sailing to the end of the world, conquered the golden fleece and return it back home. I would like to thank each and all of our Argonauts for their unwavering commitment. I would also like to thank our stellar shareholder base which have given us the trust and the support to build an incredible company with an even more incredible value creation path in front of it. Thank you.

Thanks for the presentation, Tim. I think you're being joined by a couple of other members of argenx's management there.

That is correct. We have Karl Gubitz, our Chief Financial Officer; and we have Keith Woods, our Chief Operating Officer.

Great. We've got 20 minutes of presentation -- 20 minutes of questions, sorry. And as a reminder, the way you can do that, you can log your questions through the website. So if you're looking at the slide presentation, there's a button to raise your question. And with that, we'll go to questions. So maybe take off the questions. And congrats on the gMG approval. Can you talk about the label, is the label all you could have hoped for? Are there any populations the label doesn't cover? And is this the final label for what you're going to have in gMG? Or could the label change over time?

Keith, do you want to comment on this one?

Yes. Thank you for the question, James. I have to tell you, we are extremely pleased with the label. I mean if you take a look at that, it is a very broad label. It covers all the way across the treatment paradigm. We have patients treated for gMG that start all the way from second line and go all the way to the severe relapse/refractory with no restrictions. Additionally, the safety profile demonstrated by efgartigimod, by Vyvgart comes very clear in the label. You don't need any premedication. There's no vaccinations required. Truly, we have a clean label, not only in our words, but also in the view of the physicians that we've been able to share it with and the payers that we've been able to share it with.

And James, there was a lot of concern or questions with our Investor Days about exactly how this drug would be dosed. Again, there, there's full dosing flexibility, the redosing simply happens based on clinical evaluation. So I echo what Keith is saying, this is a very strong label.

And in terms of where are we now on commercialization plans, when could we start to see some sales for the product?

Well, the team has already been out there. As Argonauts, we don't take off the Christmas and New Year's week and say, let's wait and launch in January. The team was already out there meeting with physicians and payers starting on the Monday after the approval on December 17. So as you know, we have a long way to go. We've shared with you that there's 7,700 treating neurologists in the U.S. and of that 7,700 in our own market research, it shows only roughly 10% were even aware of FcRn. So we have already started the process of commercialization. We are already working with physicians, some who have already identified patients. I just want to call out teams that most of those that have called out to us that they've identified patients are the same physicians that had already used Vyvgart during the clinical trials. So a lot of education ahead of us, but we're off and running.

And so one factor would be positioned awareness of the product, but another would be reimbursement. In terms of what do we actually need to do in terms of things like J codes and even when you get the J code, could there be other gating factors that we need to be mindful of when we're thinking about the launch?

Yes. I mean I hope you see from our announcement that we shared on December 17 that one of our plans around reimbursement was early engagement with national and regional payers. And we've had them under CDA and have been working with them with efgartigimod, with Vyvgart for quite some time. That's why we were able to say on December 17 that we had EBAs in principle, in place. Now what's the next step? It's to take those EBAs and have them formalized in the first half of this year. I think you'll see policies that will be established in the first half of this year. And also, we are on track with the J code as we had said to submit for our J code and have a specific J code to Vyvgart by quarter 3 of 2022.

And how much impact did that have ahead of having a J code? Is that going to be a very new to launch or can you still achieve significant size even ahead again that [indiscernible]?

I think it's going to be -- it's going to vary on an individual-by-individual basis, okay? Certainly, we are putting tools in place for without having a J code, if you are a buy and bill office, and this would give you hesitation, we're putting tools in place that might help to ease that pain. It's not going to shorten the process, okay? We're still going to be going through appeal process. It's still going to take a little bit longer, but we want to make it to where it's not as painful for the office to experience. Some offices, they will say, we're going to take the extra step. We will do this. We appreciate this, and we want to get this product to our patient. Others, it might be a little bit of a wait and see. It goes right back with the early adopters and those that come on slightly thereafter.

And how as investors or as analysts should we track the launch. Is this something where we can be able to look at IQVIA data? Or will argenx be giving us information about patients that are on drug or vials or how are we going to be able to follow what's going on? What's the best way to understand what's going on with the drug like this once it does launch?

Yes. I mean the first thing I would say is we have always been guiding to a gradual consistent growth with this launch. That does not change after approval. It does not change in the first few weeks of feedback. There's an excitement around FcRn for those that we get to speak to. But we're in the minority of people that we are able to speak to right now. And quite frankly, James, the spike that we're seeing in the pandemic is not actually opening more doors. We're actually having to transition back to more virtual. So really, that is probably one of the biggest concerns around education. It's also one of the biggest concerns around patients coming to their physician office and trying out a brand-new biologic for the first time ever. So we continue with the guidance that we have. As far as what type of metrics and such that we'll share with you during the launch, it's early to say. I can tell you that we've been studying peer launches and such but 2 areas that I think are really important is the demand, right? The demand for the product and ultimately, how are we doing with covered lives and coverage with payers. So those are 2 areas that I think you can expect to get more color on it after the end of the first quarter.

And maybe one for Karl, which would be, does this shift how argenx does guidance? Will we be getting like an annual projection for the product is going to sell or anything like that? Or does that only happen if it happens later down the line?

Yes, it'll only happen later down the line. We're not going to give specific guidance now during 2022.

And maybe just 2 other considerations about how the launch might go. So one would be, do you think -- and clearly, [indiscernible] promote off-label, but do you think that this is a product that is going to be used very strictly according to the label or could doctors actually use it for some other things as well. I know that MG is treated by the same type of physicians as another disease CIDP where you're still running trials. And there's all sorts of other autoimmune diseases that aren't particularly well treated or very well served at the moment. So do you think it's a sort of condition where people are going to very narrowly keep the label? Or could there be some [indiscernible]?

Well, James, let's be really clear that as argenx employees, we will only promote to the label. And that will be the extent of our promotion. I can't comment on what a physician would choose to do. I know that many physicians are excited about the other indications that we're currently studying. I mean you heard Tim in the presentation today share with you that 2 of the new indications came to us from physicians that ask for efgart for particular areas. But as far as promotion, we will strictly promote on-label for gMG and acetylcholine receptor positive patients.

Maybe one more question about MG or 1 or 2 and then I'll move on to the other areas we'll be talking about. But one other question would be just the competitive outlook and the differentiation because this is the first FcRn inhibitor, but it's not the only FcRn inhibitor out there. And there's also other therapies like C5 that are on the market already and potentially more coming to market for MG. So what's the differentiation, particularly in MG for this FcRn versus other ones?

Yes, I will take this question, James. So first of all, let's focus on the patient. I think it's excellent news for the patients and the entire MG community that finally, there is innovation coming into that space. This space will start for innovation, and this is a very serious debilitating disease. That's the first thing I would like to say. Secondly, I think Vyvgart is exceptionally well placed to serve the needs of these patients. You do know that MG is driven by pathogenic IgG [indiscernible]. I mean they are the cause of the problem. At the neuromuscular junction, they block signal transmission. They will cross-link receptors and internalize and making them available for signaling. And these autoantibodies will also recruit complement is one of the many things they do at a junction which is creating a problem. So by removing the pathogenic autoantibody, you hit the disease in its heart, okay? That's the first thing I want to say. Secondly, I think efgartigimod, which is engineered to optimally interact with FcRn has put the bar really high. If you're a physician, if you're a patient, you know that you have about an 80% chance to derive a clinically meaningful benefit during the first 2 cycles of treatment. So that's within just a few weeks. We also know that you have a more than 80% chance to respond after the first or second infusion. And we know that we put 60% of patients into minimum symptom expression during the first 2 cycles that means for the audience that the patient can walk around without any meaningful symptoms of the disease. This is the Holy Grail. This is the best thing you can achieve next 2Q and we do not know how to cure MG. So from an efficacy point of view, I think the bar is high. This is very exciting for patients. From a safety point of view, this is the first time you are offering a drug where you do not seek a trade-off between symptom suppression on the 1 hand and managing side effects of the drug on the other hand. I mean this is a clean safety profile, no distinguishable from placebo. That's exciting. And then from a convenience point of view, we're the only company which has shown data for both in IV and subcu product presentation. And we explained before, James, that we think both product presentations will be complementary, right? So in order to serve the community in the broadest and the best possible way, we know we need both the IV and the subcu products. So I think we're putting the bar pretty high, and this is very exciting news for MG patients and their community.

I've got a follow-up question from someone on that, which is -- so the question is, is the subcutaneous form a must have for long-term competitiveness for Vyvgart? And also what is the timing that you could have to the subcutaneous version approved?

Maybe, Keith, you want to take part 1 of the question, and then I will take the second part, okay?

Yes, I'm happy to, Tim. James, what I would first say for that question is when we have surveyed patients and physicians, the #1 criteria that they're looking for in a product is clinical efficacy, followed by safety, okay? Route of administration does not fall as high amongst the priority. But when we think about Vyvgart, we think about the possibility of this pipeline in a product that's serving 15 indications or better, that's going to be globally available. And we know that there are different dynamics in different markets across the globe and having the optionality to have both IV and subcu is absolutely the best option for patients, for providers, but also potentially for payers. So is it a must have? I don't know if I would say it as a must have. Does it strengthen our position as a whole? Absolutely, it does. Tim?

Thank you, Keith. And on time line, look, the good news, James, is that we could now refine the guidance for readout of the MG Subcu study as being Q1 this year. So this is around the corner. And it's a very exciting study because it's a non-inferiority trial between the subcu product and the IV product based on total percentage IgG reduction. The rate limiting step for filing then the BLA and this will be a separate BLA because it's seen by the FDA as a combination product with Halozyme's Enhanze technology is going to be the safety data package. So again, the good news is that we did triangulate with the FDA on exactly what is the safety database they want to see in the filing in terms of number of subjects and duration of the exposure. We will be able to give you more clarity on the speed by which we were able to build that safety database. It's still a bit too early to talk about it. But that will be the guiding step, the rate-limiting step for filing of the BLA. And remember, we also have a priority review vouchers, PRV. We may or may not decide to play that card, depending on a number of business considerations, but this could be one of the ways to accelerate potentially the path to approval.

I've got quite a few questions on other indications. Maybe -- So 1 question has been about -- a good segue, it's been about CIPD and the data timing. I may be [indiscernible] to tag on to that one, just if you could remind people sort of how you see the risk profile in CIDP versus some of the other indications, whereas I believe some of the indications we've seen detailed data presented whereas we have them for CIDP.

L That is correct, James. And remember the reason why we could not disclose a full data -- set of data readout is because this was and is a registrational trial, right? So if we would have completely unveiled the data set, we were basically exposing ourselves to the risk that this study would be basically seen by the FDA as just a Phase II study and no longer a Phase III study because we could have biased the study. So what we do know is that the signal our statisticians have seen on the back of the -- on the basis of the first 30 patients that we believe that signal is reasonably exceeding a placebo response. We know that with a 95% confidence. And remember, we feel strong about CIDP. And people do believe it's a pretty heterogeneous disease, and they believe so based on the clinical presentation, there are various subsets of CIDP based on clinical symptomatology. Now we believe when you look at CIDP through the lens of immunology, this is just an autoimmunity by IgG autoantibodies on the peripheral nerve system attacking autoantigens on the Myelin sheath and Schwann cell. So from an underlying balance sheet point of view, we believe this is an IgG mediated disease. And we believe so because techniques which specifically and selectively remove IgGs only like immunoadsorption, they have a higher response rate in CIDP than IVIG. So I think that's all boding very well. We are really looking forward to reading out the Phase III trial, and we have now been able to give guidance that this is an event likely to happen in Q1 next year.

Thank you. And one other question about other trials. So the question has been the two of the new proof-of-concept indications are partnered with IQVIA. So why have you chosen to partner for trials?

This is basically a strategic consideration, right? So in front of you, it's an abundance of opportunity, and we're scaling this company at a pretty high speed. So we just doubled the company last year. And the strategic question is how do you continue to add indications in a responsible way. So we're really leveraging here, on the 1 hand as Zai Lab strategic alliance. We always expressed our excitement about Zai Lab as a strategic partner not just to bring the product to market in China, but also to leverage the development ability to add proof-of-concept trials. We're now doing the same with IQVIA. So we work with a number of CROs. This is an innovative model where IQVIA is, in fact, taking on more responsibility than they would typically do under a CRO relationship. But everything continues to be under the R&D covenants of argenx. So here we're now working with a network of strategic partners to try and realize, capitalize on a huge abundance of opportunity in front of us, which efgartigimod representing.

If we shift to another indication, which is ITP, where I believe you will find the time lines, so we're going to get the Phase III data in Q2 this year. So how confident are you in success there? And I know in the Phase II data before there were some patients that had bleeding, but then could that be part of the disease. So confidence there on efficacy and any side effect risk around that readout?

Yes. Let me comment on bleeding first real quickly, James. So there was no significant bleeding in the 5-milligram or the 10-milligram per kilogram efgartigimod arms. We only had mild skin bleeding of [indiscernible]. So there was no signal of bleeding in both arms, and we published that in a very nice publication in blot. The first thing I want to say about ITP is there is strong conviction on the biology. We do know this is an IgG mediated disease. Pathogenic IgGs, they basically accelerate the destruction of the platelets. They will attack the megakaryocyte in the bone marrow, which are producing the platelets, but they also impair platelet function. So just looking at plated mean platelet count doesn't help you if your platelet is basically covered by pathogenic IgGs, it cannot undergo the 3D change. It needs to undergo in order to, for example, form the plug and stop bleeding. Now what did we see in Phase II? What we saw in Phase II is actually a very attractive signal in a pretty relapsed/refractory patient population, we had a 46% response after a very short exposure of these patients to the drug. Mind you, they only received 3 weeks of drug. The surprise in the Phase II study was that the placebo patients actually have platelet counts, which [indiscernible] all the time too. So it's not difficult for placebo patients to accidentally hit the 50,000 platelet mark and therefore, be counted as a responder was in fact another response. So the primary endpoint in the Phase III trial is really leveraging that insight and learning. So we now demand some level of durability in your response. We want to see in at least 4 out of 6 visits between week 19 and 24 a platelet count of 50,000 or more. And we hope that's really going to differentiate the real signal of efgartigimod from the placebo noise. So what we are hoping for is a statistically significant delta between efgartigimod on the 1 hand and placebo on the other hand for the primary endpoint. And then the secondary endpoints are designed such that they will be able to provide much more color on the value and the specifics we can bring with efgartigimod to ITP patients, they will also be very informative about how we can think about positioning efgartigimod in the ITP treatment paradigm.

Maybe the same source of question, but for the other key readout this year, which would be PV? So how confident are you on PV? Are there anything in areas where we need to be cautious pace in the Phase II? Or are you able to see anything clever that increases the chance of success for the Phase III?

Yes. Thanks for that question, James, again. Very strong excitement about the underlying biology in pemphigus. I mean, just like myasthenia gravis, this is a poster child indication when it comes to understanding that this is IgG-mediated. We did a lot of work in Phase II. Remember, we had these different cohorts, learning how to dose in such a bad disease and how to synergize with low-dose corticosteroids. So what is important for patients is that you close the skin lesions as fast as possible. You stop the formation of new lesions and basically, the skin needs to get clear of lesions. The second important thing for them is steroid tapering. I mean they hit steroids with a passion. So the primary endpoint is about trying to create a delta between the treatment arm and the placebo arm in terms of achieving complete remission. That means lesion free skin on minimum therapy that's really on the lowest possible dose of steroids. And again, in the secondary endpoints, we will accumulate or we will collect evidence on steroid tapering going to complete remission of therapy, quality of life and things like that. So again, I think a very well designed, very well thought-through study design with a tough primary endpoints really seeking to differentiate statistically, significantly from placebo. This is not an easy indication to do a Phase III trial.

I think maybe we've got that for one more question. So I have a question. Who is doing the manufacturing and who is doing the manufacturing specifically for China for the commercial product? And will you ultimately be having the product made in China?

So James, we continue to take control and have control over manufacturing. As we explained before, we're working with some of the best in our industry. So we are manufacturing out of 2 commercial plants of Lonza, 1 in Europe, 1 in Singapore, and we are investing heavily in [indiscernible] to the East Coast here in the United States as fast as possible. We will continue to manufacture out of these plans and supply our partners, including Zai Lab to serve their markets.

Great. Thank you very much. I can see we're just about out of time. So I think we're going to have to leave it there. So thanks very much for joining us today and enjoy the rest of the conference.

James, thanks for having us.

Thank you.

Thanks, everyone. Bye.

Thank you, James. Take care.