Good afternoon, everyone. Sorry for the slight delay, technical difficulties. Bart, myself, and the team were in separate rooms. We're here now, day two of Citi's BioPharma Conference. It's Peter Verdult here, and on behalf of the team, I'm delighted to introduce Bart Filius, President and COO of Galapagos, along with the IR team. Bart's going to make some introductory remarks before we head into Q&A. As I always say, I'm here to moderate, not to monopolize. You do have the function on screen to submit your questions, they'll be emailed through to me, or you can just email me directly. I will make sure anything that comes through gets put to Bart and the team. Without further ado, Bart, over to you.
Yes. Hi, Peter, thanks for having me in the conference. Pleasure as always, to speak with you and the rest of the audience. Indeed, I thought it would be good to just take you through a couple of slides, roughly 10 or so, to give you the highlights of the Galapagos story as it stands today. Happy to spend the rest of the 45 minutes that we have together to do Q&A. Sandra from our IR team is going to switch slides. Maybe, Sandra, you can start with the first one. Highlights. We think current valuation of the company is actually an opportunity for investors.
The key elements of the investment case are a very strong balance sheet, a EUR 5 billion cash balance at the end of June, and a very strong collaboration with Gilead, that can benefit from, let's say, a scientific collaboration, but also indeed, economical collaboration. Jyseleca as a second pillar under the company is the brand name of our product filgotinib, which is now in the market in Europe. I'll say a few words in a second about where we're doing and how we're doing with our commercial efforts there. We have a deep pipeline in inflammation and fibrosis, with both a very attractive preclinical, but also some interesting clinical assets to look to. I'll say a few words later down in the presentation about what we think we can expect in the months and years to come in terms of clinical evolution there.
Lastly, we are interested, as we have announced previously, to use at least a portion of our cash balance for business development, to get our pipeline, let's say, rebuilt after what has been a pretty difficult 12 months for the company and the investors in our company, with a couple of scientific setbacks that we had to absorb. BD can be an angle to support rebuilding that. Currently, we are trading at levels that are below our cash balance of EUR 5 billion. Hence, we think that with the assets that we have in place, it actually is a good investment case. We have done, on the next slide, a strategic review of the company together with our board, and we have highlighted what we would call the four strategic imperatives for the company.
First of all, we want to make sure we get our organic R&D back on track, and we have refocused our pipeline. We've taken a couple of products out of our pipeline and wanted to be sure that those products that are in there, those projects that are in there, remain the core interests for the company to move ahead. We've also taken a very serious look at what we would call lessons learned from, let's say, the clinical setbacks that we've had over the last 12 months to ensure that we can use those lessons going forward in our R&D work, as it's going on in the company organically. The second key strategic imperative is to make Jyseleca a success. We're doing that exactly in Europe. We're well on track in terms of reimbursement progress in the various countries in Europe.
I'll say a few word about that in a second. BD, scouting for opportunities. I think there's two angles that we're after. One angle is to leverage our commercial infrastructure in Europe, seeing if there are, for example, U.S. biotech companies that do not have such infrastructure, and that actually would be interested to partner up with Galapagos, that can actually provide for that infrastructure in all of the different countries. I think for the right opportunity in the right therapy area and the right size, that could be actually an interesting win-win between us and the third party. The second element that we're looking at in terms of BD is to what we call fill the gap in our pipeline. We've lost an important phase II and an important phase III program in the last 12 months, and that's what we're trying to recuperate from.
We think that our cash balance is an excellent opportunity to scout for replenishment of our late-stage pipeline to ensure that it doesn't take, let's say, the three to five years that it would otherwise take with organic R&D development to get back on our feet. Lastly, what's really important is also financial discipline to make sure that we spend the money on the right projects, on the right efforts. We are executing on a major savings program that we have started following the Ziri setback earlier this year, which is generating about EUR 150 million of annual savings, half of which to be realized still this year and half next year. That reflects roughly 25% of our intended cash burn for the year.
Lastly, we are also, and it's been announced last week, looking for a new Chief Executive Officer and a new Chief Scientific Officer for different reasons. The departure of both Piet Wigerinck, our CSO, and Onno van de Stolpe, our founder and CEO, have been announced over the last months. We are looking, or the board, I should say, is looking for suitable external candidates to strengthen the management team. A few words maybe on the financials, on the blue element there. Cash burn is expected to peak this year at roughly EUR 600 million. This slide is trying to give a bit of perspective as to what actually is the underlying, let's say, run rate of cash burn at the company.
If you look at the EUR 600 million that we are this year spending, it's roughly 70% focusing on what we would call R&D and roughly 30% focusing on Jyseleca. Let's not forget, Jyseleca is not just about the commercial efforts in the marketplace, but it's really also about finishing and continuing some of our long-term extension studies and finishing our Crohn's phase III program. There's an important investment in the next couple of years still to have for Jyseleca to finalize the development path. Going forward, the R&D burn, as I announced just now, we are pushing the expense down there.
We actually think that the, let's say, approximately EUR 400 or EUR 425 that we would be spending on R&D there this year will be pushed down already next year to roughly EUR 350, which if all things are equal, would be our run rate of underlying R&D expenses. The Jyseleca burn by itself will go down. Next year, it's not going to go down that much for the simple reason that our cost share next year is with Gilead, which is a 50/50 cost share in 2021, will go away. That's compensated by the sales that is also 100% in our pockets. We should be able to get to a breakeven territory in the course of 2024. That will bring our cash burn for Jyseleca down to zero by the time we reach that stage in the decade.
Actually, if you look at the outer years of the decade, at peak, we think Jyseleca can be a EUR 500 million product. The contribution from that product, even taking into account fully loaded G&A, et cetera, could be in the vicinity of roughly EUR 200 million. As a result, our actual underlying cash burn will then go down quite significantly in the years beyond 2024. Just to highlight, because it's a point of attention, obviously, for investors, our cash value being an important pillar under the value of the company, that we are going to be extremely careful and disciplined in terms of how we spend our money over the next couple of years. What is to be expected in terms of outlook for the next years? 2022 will be the Jyseleca franchise buildup and the rebuild of the pipeline.
We'll have data on the MANTA study. We'll have, hopefully, the launches of Jyseleca in Europe and Japan in ulcerative colitis, and we anticipate CHMP opinion shortly on that filing. We will also have top-line data from our program GLPG0555 in OA in phase I-B in patients. We'll have top-line data from a phase I in healthy volunteers with our SIK2/3 inhibitor, and we should be able to start next year two phase II programs, one with the TYK2 inhibitor GLPG3667 and one with GLPG4716, a chitinase, which we're going to progress in idiopathic pulmonary fibrosis. In 2023, we will be able to see some first data sets coming out of some of the ongoing trials. We have then still the filgotinib or Jyseleca data on Crohn's disease to come. We have a program in kidney, GLPG2737. We should see phase II data by then.
The TYK2 data should be generating top-line results as well in 2023. Hopefully, we'll be able to start a new phase II program with our Toledo compound or new Toledo compound, GLPG0623. A lot going on in the next 24 months in those two years. A quick word maybe on commercial, as I promised. How are we doing? The market launch is on target, and that is really reflected, first of all, in the level of reimbursement that we're getting. As you know, in Europe, you really go country by country to get reimbursement, and that's very specific also in terms of exact population, exact price, exact reimbursement scheme by country, and we're making good progress to have all the key countries reimbursed by the end of the year, maybe even by the end of this quarter. Market launch on target.
It's a bit too early to say a lot about the actual market performance. The only country where we are in the market for a little bit longer than one or two months is Germany. There we are in line with our own internal budgets. We're happy what we are seeing so far. We're nearly recruited with our phase III program in Crohn's disease, which is an important extra indication to the molecule. We are filed with the EMA for ulcerative colitis. We're also filed for ulcerative colitis in Japan, by the way. That's marketed by Eisai, who has partnered up with Gilead for Japan. The key message that we're putting out there is that we are a preferential JAK1 inhibitor. That's also reflected in the label with that same wording. That resonates well with healthcare professionals.
We see that we have a differentiated option there for prescribers. All in all, we think this could be a profitable business case, as I explained before, for Galapagos. Then moving on to Research & Development, our pipeline. I've said a few words already on the different data points and readouts that we should be expecting over the next 24 months. Here in the slide with arrows, you see the overview. Indeed, our JAK1 inhibitor filgotinib, and GLPG0555 are there. Our TYK2 inhibitor are going into phase II next year. We have three compounds, or actually it's four compounds, I should say, but it's likely going to be three because we're going to choose one of the two candidates for SIK2/3 inhibition to go into phase I next year.
We have also a local application, JAK1/TYK2, which goes under the code name of GLPG3121, and that's in IBD. In IPF, we have three programs as well, the most advanced being the chitinase program. Lastly, one kidney program in polycystic kidney disease, GLPG2737, which is currently in phase II and should show data in 2023. Maybe a quick deep dive on first the TYK2 and then on the SIK inhibitor. We think this can be an extremely interesting new class of oral medication. We know BMS is currently undergoing regulatory review, at least in the U.S., with their TYK2 inhibitor. We think that actually our TYK2 inhibitor, which is really selective for that member of the family, has a good deal of promise there to be competitive. We don't know yet exactly where and how and how it's going to be differentiated.
That's going to be the key focus of the phase II study that we intend to start next year. On the next slide, some outcomes that we've seen before is positive top-line data in a phase I-B in patients, where we've seen that 4 out of 10 patients on the high dose reached a PASI 50 response, as opposed to 1 out of 10 on placebo. Now, admittedly, those are small numbers, still they give promise, we think it's really worthwhile to test this further in psoriasis in the phase II-B, we'll also start a phase II study, a smaller phase II study in ulcerative colitis in the course of next year. That's an important effort for us in that class. Lastly, maybe quick words on Toledo. Toledo is the code name for a series of compounds that are SIK inhibitors.
We've seen in the discovery work, we've seen very interesting animal results, animal data, where we see the dual mode of action from the SIKs in terms of working towards regulatory cytokines as well as to the pro-inflammatory cytokines. That has led us to a phase II program with our initial compound GLPG3970. I think I have a slide on that one as well, where the top-line results were encouraging in psoriasis. They were a bit mixed in ulcerative colitis, some signals of activity, but not yet the level that we would like to see, and they were negative in RA.
We have come to the conclusion that we like still very much the targets and the biology that we're after here, but that we need a compound with higher target engagements to test further in the clinic to evaluate whether we can actually get a compound that can reach the finish line or can reach later stages of development. That brings me to my concluding slides, outlook for 2021. These are the outcomes that we've promised. We've seen the data in GLPG3667 and the SIK2/3 inhibitor. We're still anticipating, and it's quite around the corner, the CHMP opinion on Jyseleca, and then hopefully also the approval by the European Commission to extend this indication into ulcerative colitis. In terms of trial progress, we anticipate to announce shortly the full recruitment of our Crohn's disease study, as well as the
Let me stop there, and Peter, back to you for perhaps moderating some of the questions from the audience.
Thanks, Bart. Pretty comprehensive. Look, I appreciate you being very candid, given obviously the highs and lows of the last 12- 18 months. Look, I think let's start with sort of the big picture questions. I think they're the most important. I realize the CEO announcement was only made literally five minutes ago, but can we just push you a little bit in terms of what is the type of person that the board is seeking to hire? Is this exclusively external, or could the candidates involved be internal and external? I'll start there.
Yeah. No, happy to say a few words, even though I should also say that this is the prerogative of the Board to make those choices clearly, this is handled by our Chairman with the rest of the Board members very closely involved. I think the retirement of Onno is not necessarily a major surprise. I think people both internally and externally were expecting this to come after 20 years at the helm of the company, having founded the company and brought it to the successes that we have today. That he moves out for a new CEO, I think is in line with expectations. The Board felt it was important to announce that before actually going active on a search for a new CEO. As far as I understand, they're going for an external candidate.
Given the, let's say, the rebuild that is required on the R&D front. This is likely to be a candidate with a scientific profile, at least in terms of backgrounds.
Clear. As you said, again, being candid, there's EUR 5 billion of cash on the balance sheet. The market cap of Galapagos is significantly below that. That's either a massive opportunity or that's a signal from how the market perceives the quality of the portfolio right now. You've made it very clear that from a capital allocation perspective, you want to put some of that cash to work because you can't wait organically for the R&D engine to be turned around. Is it also fair to say that nothing will happen until a new person arrives, or is that incorrect? Are you actively involved at the moment in BD?
Yeah. I wouldn't go too far to say that nothing will happen until a new person arrives. I don't think that's necessary. The executive team is also mandated by the board to continue with business development. It needs to be, obviously, business development that's in line with the strategy of the company. You'll not see us making. We wouldn't do that anyway. As an example, you'd not see us make a multibillion-dollar acquisition in an Alzheimer space, for example. If we'd want to go there, that's probably a little bit more of a big strategic shift for us.
As long as it's within the strategy of the company in inflammation, and if it's not, let's say, betting the bank, I think, we're definitely mandated to move ahead and we'll bring forward proposals to our boards and they will look at them and see if they make business sense, and we can work on that.
Just two clarification points. Again, big picture. You got the lockout with Gilead, until 2024. That's a given. What about, when it comes to the assets, the SIK and TYK2 that you're developing, do they have to be opted in by Gilead? Is that part of the deal? Would they need to sort of green-light and partner with you? If they didn't, would you be prepared to sort of go it alone as it relates to mid- to late-stage development? I'll pause there and ask my second question after you've answered that one.
Yeah. The current structure of the deal with Gilead is quite straightforward. Any compound that we bring to the end of phase II-B, they have a right to opt in. If they do not opt in, we have the right to still continue with the compound, obviously we will be bearing 100% of the cost as well. If they would opt in, it's a cost share from there on, 50/50 between the two companies. They have the rights to exploit the compound outside Europe, and we have the right for Europe. They pay us royalties as well, Europe is unencumbered ours. That's the basic structure. By the way, they pay us a milestone for the opt-in, $150 million for any opt-in that they would take.
Indeed, if they would choose not to opt in, we could move ahead if we believe that it's a viable path, but then we bear the cost ourselves as well.
Very clear. Just lastly, you've had to obviously do a cost savings program. At the same time, you're trying to maintain a discovery engine and commercialize Jyseleca. How have you managed that balance and not just completely disrupt the company? Can you just talk a little bit about that?
That's a great question, indeed, we need to be careful that we balance that properly. I would indeed say that those areas in the company that have been most affected by the cost savings program are the development organization and the support organization. The commercial organization is obviously trying to do as efficiently as possible the launch of the product, but we do want to give them the right chance and the right opportunity to actually make a success out of it. We do need to invest to make that happen. On the other end, in the value chain, in discovery, we think it's also extremely important that we continue to invest in our early-stage research work. That's where it all begins. That's how we can differentiate ourselves from the competition.
That's also not the area of focus in terms of the cost saving, but it's more on the project side, in development and in all the supporting functions as well.
Got it. In the world of JAKs, look, we've seen a couple of things happen in the last few weeks. The U.S., I don't think anyone's surprised, they went ahead and slapped on the black box warnings for the JAKs. We've also seen in Europe two JAKs approved for atopic dermatitis. I was just wondering, I suppose a two-part question. One, when you think about developing your TYK2, there is a sort of concern that the FDA might do the same with the TYK2 class going forward. Also with your efforts potentially still to get filgotinib approved in the U.S., just how you're thinking about the risks or not that these regulatory changes are bringing to the filgo program.
Maybe take the last point first. In all fairness, Gilead has been communicating about that as well in their quarterlies and in different conferences. The base case is that Jyseleca will not be marketed by Gilead in the U.S. It's as plain as that. As painful as it is for us as a company because we believe we have an excellent drug that is really a solution for patients. The regulatory environment is clearly not working in our favor. The one caveat or the one question mark that we have, and that Gilead has, is what are the data from the Crohn's trial going to show us in about a year and a half from now. If there is a major breakthrough in terms of outcomes there, that would probably allow for a revisit of that decision.
I do not anticipate that Gilead will, in the short run, make any efforts to get filgotinib to the U.S. market. On your second question, what is the regulatory environment applying to the TYK2? We will know the answer, I think, somewhere in the next, let's say, six months or so from the evaluation by the FDA of the BMS program. That should help us understand how they look at the TYK2 in relation to the other JAKs. We think that both our compound, and by the way, also the BMS compound, are highly selective for TYK2, and should avoid some of the liabilities on some of the JAKs. I would find it reasonable if it would not affect that label in the same manner as they've treated the JAKs in RA.
I obviously cannot speak to how the regulators look at that, who have not always been as, let's say, precise in their application between, let's say, different JAKs and the TYK. Let's see. We'll take it when it comes.
That's fair. Just look, I have to ask. You say it yourself, Bristol have already got a full phase III data package filed for TYK2. It's way too early for me to start asking you about differentiation because you haven't got the data yet to answer that. You also going to be bringing a TYK2 in OA, osteoarthritis. I'm just trying to work out, what is the mindset here? Are you just thinking, look, the mechanism is attractive, hoping to get a partner. I just want to understand why you're sort of prosecuting those assets given the sort of current environment, both in terms of the competitive landscape and potentially how the regulatory landscape might change.
Yeah. Just as a clarification point, we are evaluating it not in osteoarthritis, but in psoriasis and most likely in UC. The psoriasis choice is really a result of the fact that we actually can compare ourselves very well with BMS because we know the data for the BMS compound in that space. That's really a benchmarking study, if you like, in phase II that will tell us whether or not we are differentiated. Ultimately, we need to be, and there needs to be a differentiation element there, be it on safety, be it on efficacy, to progress with the compound. Today we need to really first do the work and analyze the data. We really like the target as such.
We think it is a good class to go after, which can really help solving some unmet needs, and it can be oral therapeutic as well. We like the class. We think it has potential. We'll need to see how we stack up against the competition at the end of phase II before we're able to conclude on how we bring that forward.
Apologies, I thought I was trying to sort of throw two assets in for one question. Correct me if I'm wrong. The asset that you are bringing into the OA, I think it's GLPG0555.
Yeah.
That is also a JAK1 or not?
That is a JAK1. It's an intra-articular JAK1.
Great.
That's a bit of a special case. Much smaller market. Let's see what the data says from that very small trial that we're running there now. That's your point taken with regard to the JAK class with regard to that compound.
Sorry, I was throwing the JAKs and the TYKs into one bucket.
Yeah.
Okay. Clear. Just to push you. You do have a lot of cash on the balance sheet. If you do show proof of concept and Gilead doesn't want to partner in, what is the mindset of Galapagos right now? Do you have to have a partner to sort of spread the risk, or is there a mindset where you would, given you have the resources, be prepared to go into phase III on your own?
Yeah, I think the fact that you have the resources should not be the reason to progress something on your own. Which doesn't mean the other way around, that you shouldn't progress something on your own, but it should not be driven by the fact that we can afford it. I think we need to be very careful, evaluate the data very carefully, understand also the reasons why our partner would not opt in very thoroughly. If they would not opt in, I think we need to be totally honest with ourselves and transparent and see, okay, is this a viable option for us as a company? That takes then also into account that we do not have a U.S. infrastructure, and we do not intend at this stage to build one either.
I frankly don't see us very quickly going into the very competitive U.S. markets in a, which you could almost call a mass market specialty product, with the Galapagos name alone. Probably it makes more sense to look for other partners as a solution. Again, it's way too early to make that call. Let's first have the data out of the phase II study 2023, and then we'll talk with our partner. I know for a fact that at least the TYK2 is a target that Gilead is interested in, is a market that Gilead is interested in. Whether ultimately it's going to be our compound good enough for them to make the investments, we'll see that when we see the data.
Do those comments apply to, I know they clearly cover psoriasis and so forth, but what about in Crohn's? If filgotinib hits in Crohn's, but Gilead doesn't want to pursue, is that still seen as a very competitive market, or is that something that might interest you or you would go for?
Yeah. It's a slightly more complex contractual situation, Peter, because filgotinib is de facto opted in. That was the original 2016 agreement that we had with Gilead. On the TYK2 that we were just discussing, it's a situation where they still would need to opt in or not. Here in the TYK2, the case is very clear that if they don't opt in, we are in a position to progress. On the Crohn's indication, it's going to be more a judgmental question on the Gilead side, whether they think there's a commercially viable opportunity here for the U.S. If they believe there is stable, they will launch. If they do not believe there is stable, they will not launch in the U.S. either. There's no immediate, let's say, opportunity for us then to do it on our own.
Yeah. Just on that U.S. Crohn's trial that's being run, is there anything you can say in terms of timelines, how it's recruiting? Just any flavor you can give on the status of that study.
Yeah. Recruitment is almost done. Literally in the next, I don't know, couple of weeks or maybe months, we should be able to conclude recruitment for that study. It's called DIVERSITY. It's a study with an induction period of 10 weeks and a total duration of, I think it's 56 weeks, if I'm precise. Let's say roughly a year. That should give our last patient last visit somewhere in the fourth quarter of 2022, top-line data probably in the first half of 2023.
Clear. Okay. Can we come back to Jyseleca in Europe? I mean, you've laid out your equations for breakeven and peak sales. I know there's not much you can say on market share performance, but how has the product done in Germany from the data that you're seeing? And if we take a sort of, I'm not asking for a blow-by-blow, but by the end of this year or by the middle of next year, can you give a sense as to how many countries you'll be launched properly and reimbursed in? Just some sort of sense as to that progression on Jyseleca in Europe.
Yeah. I think we should, again, taking the last question first, we should be launched in all the key countries in Western Europe by the end of this year. Currently Germany, France are in the market. U.K. is in the market. Italy has just been announced reimbursed and will be in the market next month. The same will apply, most likely to Spain. The smaller countries, the Nordics, we're there. In the Benelux countries, we are there. In the vast majority of the Western European markets, we will be in the markets by the end of the year. We'll be able to start tracking seriously how the performance of the drug is doing in all of those countries. Hopefully, we'll be also able to add a second indication if we get a positive decision by the European Commission later this year as well.
Then the whole, let's say, reimbursement track will restart. First, again, probably Germany and the U.K., generally the early launch countries also for new indications. During 2022, we'll be able to add France and Spain and Italy and so on. These two years, 2021 and 2022, the real key focal point for us as a company is to make sure we get reimbursed and we get access to the patient population. In the meantime, we want to track obviously how we're doing with actual in-market performance. On your first question, how are we doing in Germany? As of June, we were in line with our own internal expectations. Those are relatively small numbers. As you know, a pickup of a drug in the early months, it always takes a bit of time to get to a proper run rate.
That's in line with our own expectations. At our Q2 call, we've highlighted, I think two market figures. One is the markets for the JAKs in Germany is progressing really nicely. I think we're talking about 15% or 16% by the end of June of this year out of the total advanced therapy market in RA. The class itself is having good traction. We've also highlighted our share of what's the dynamic market in RA, which at the end of June was up to 4%. That means that for those patients that are either switching from existing therapies or naive to advanced therapies coming off, for example, methotrexate, we're able to capture 4% out of the market. That's a market that includes then also the biologics. That's a decent place to be.
As an overall perspective, we've indicated that at the peak, we want to be in the RA market, let's say somewhere around the 10% market share. That means that you need to have a good number of years of that type of market share in the dynamic market first to get to that level. We're okay with what we've seen so far.
Just to push, have you got any other data points that you've seen of late beyond what you cited at Q2 and the June data that you just mentioned?
No. We'll leave it at that for the time being. What I did say there was that once we do the Q3 results, we'll give a bit more perspective as well. This is going to be late October, early November. One of the caveats here, it's a bit technical, we're still in transition from Gilead to Galapagos for the marketing authorization as well as the sales distribution. Actually, our own Galapagos sales in Germany is only starting as of Q3. All the sales that was done early on in the year was still done at the side of Gilead. What I'm going to be trying to do when we present our Q3 numbers is to give a bit of market perspective to the streets as to how combined between the two companies, we're executing on our launch efforts.
When will we actually see a clean Jyseleca number reported by Galapagos? Is that not until Q4, or will the Q3 number be a clean number?
Yeah, it will never be clean because, for example, the U.K. is not yet fully booked by us, and the Nordics are not yet fully booked by us. Clean, it will only be in full as of the end of this year.
Okay
Going forward. Obviously, we can give some insights and some perspective how we're doing in the marketplace, so that you have a better chance to evaluate this more closely.
Just wrapping up because I see we're fast running out of time. Just when you think about, obviously, this is the asset that you need to make work from an NPV perspective, where are you currently on the IP and potentially seeking SPC or PTE? How do you think about the IP situation for Jyseleca?
That's the reason why we think it's actually a very attractive opportunity for us as a company, financially attractive. We have IP, including the extensions until 2034. If we are able to get to breakeven in 2024, that gives us a good 10 years of life in positive cash flow territory. That's why we think actually it's attractive to keep on pushing Jyseleca.
Obviously, the key now is to get people to believe more in the pipeline. You helpfully gave a summary of the next data points, but in terms of the nearest couple, when are we next going to get data on the TYK2 or the Toledo program? Are we talking back end of next year or as soon as first half? Can you just remind us those sort of data points when they come to sort of assess the pipeline and potentially drive a little bit more investor confidence in the pipeline?
I think that's why we are starting to give a little bit more insight into what 2022 and 2023 are actually going to look like. It's fair to say that the TYK 2 and the Toledo program will not give data yet in 2022. That will be in 2023, together with the kidney program. That should also be in the course of 2023. 2023 is going to be a bigger year from a data point of view, there are some interesting readouts to come as well in 2022. Obviously, there is all the work around Jyseleca, which is going to be front and center, I think, on the communication front in 2022. I think you are on mute now, Peter.
Yeah, I was saying the year of Jyseleca, obviously knowing the new strategic direction and CEO. Well, listen.
Yeah.
I wish you all the best with the launch of Jyseleca, and look forward to charting your progress going forward, too. On behalf of the team, once again, thanks for you participating at the conference this year.
Thanks, Peter, and thanks for having us at the conference.
Thanks, Bart.