Galapagos NV (GLPG) Q3 2021 Earnings Call Transcript

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Galapagos NV (GLPG 1.31%)
Q3 2021 Earnings Call
Nov 5, 2021, 8:00 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good afternoon, ladies and gentlemen and welcome to the Galapagos Financial Results Q3 2021 Conference Call. [Operator Instructions] I would now like to hand over the call to Sofie Van Gijsel. Please go ahead.

Sofie Van Gijsel -- Director Investor Relations

Thank you operator and welcome all to the audio webcast of Galapagos Q3 2021 results. I'm Sofie Van Gijsel, Investor Relations representing the reporting team at Galapagos. The Q3 webcast is accessible on the Galapagos website homepage and will be available for download and replay later on today. I would like to remind everyone that we will be making forward-looking statements during today's webcast. These forward-looking statements includes remarks concerning future developments in the pipeline and our company, sustainable changes in the industry and competitive environment. Because if the forward-looking statements [Indecipherable] Galapagos actual results differ materially from the results expressed or implied [Indecipherable]. Today's speakers will be Onno van de Stolpe, CEO and Bart Filius COO and President. Onno will be reflect on the operational highlights and, Burt will go with the commercial and financials results as well as the expected [Indecipherable] for the year. You will see a presentation on screen. We estimate that Research remarks will take about twenty minutes then we'll open it up to Q&A with [Indecipherable] joined by the rest of our management group. And with that, I'll now turn it over to Onno.

Onno van de Stolpe -- CEO

Thank you, Sophie. Good day everybody. Thank you for joining this webcast and you already experienced and heard the changes. We have a change in IR, as well as in leadership. This will be the last webcast where Elizabeth will be part of the Galapagos team and Sofie is taking over and also this will be the last webcast where we think our CSO is present. So I would like to thank both of them for the fantastic services over the years and their contribution to building the company to what it was. It has been a fantastic journey and an honor to work with you guys. Thank you very much. Let me give you a short Q3 update if I can get to the next slide. We reported positive Phase 1b data with Arctic 2 molecule in psoriasis. We are excited about this mechanism and about a molecule. We are planning for two Phase 2b next year in psoriasis as well as in ulcerative colitis. So we're moving forward with that one. We reported biological activity in our SIK program with 30, 90, 70 both in UC and psoriasis, although we also had a disappointment in RA. Where we didn't see any activity, it's clear that we are unlocking a new mechanism for the treatment of inflammatory diseases. We still have one trial going and children's disease that will read out next year.

And we are busy in research to come up with new SRK molecules with specificities to tackle the problem of the activity in these diseases. Good news that after quite a long time, the diversity trial is fully recruited that's the Crohn's disease trial with filgotinib that is in a Phase 3 and that will read out next year. And then we're very pleased with the positive CHMP opinion on filgotinib first if colitis and we are expecting any day now the approval by the EU for filgotinib in most of colitis in Europe. In the meantime, we are launching filgotinib their silica in Europe that launch is on track and we will be reporting and the sales of the first months and Bart will give more view on that and you can ask questions to me later in the Q&A regarding the start of the commercialization in Europe by Galapagos. As you know, we are in full recruitment action regarding a new CEO, and a new CSO and that is ongoing. We've got good candidates, both for the CEO as well as the CSO identified. Clearly the CSO candidate will only join after the CEO has been appointed, at least been announced so a little bit of patients there is necessary. If we go to the next slide, we are very pleased that we have taken over all responsibilities regarding the Crohn's disease trial with filgotinib to diversity trial from Gilead. It's good for Galapagos to be in the driver seat here and to move this program forward.

The details are that we got a payment of Gilead of EUR50 million for this handing over of the trial and also importantly, we were able to negotiate the reduced royalty rate of the sales that we have to pay to Gilead to Europe of EUR5.6 to EUR10.5 on all indications of filgotinib. So also in RA as well as in UC when filgotinib gets approved in Crohn's disease. So that's in there, an important achievement for Galapagos. Gilead remains responsible for all commercial activities outside Europe, and we have taken over the majority of all the commercial activities in Europe and that will finally be finished by the end of the year. So if we go through the pipeline in the next slide, you see the problem that we are having in the pipeline, you see filgotinib advanced to commercial filing which you see in Phase 3 with Crohn's disease, but after that we have a big gap with the rest of the pipeline. After the affiliates, we have had earlier in the year in IPF and in OA as we now have an earlier stage pipeline with programs in Phase 1 and Phase 2. It's very promising but we need to progress these molecules toward the later stages as soon as possible. There is a case here, the [inaudible] that already was mentioned, we have in fibrosis very exciting molecules that are still very early, but hope to make a big difference there.

And then we have one program in kidney disease that is currently in Phase 2a which is in the CFTR molecule that's Galapagos developed. So, we are moving forward to our pipeline, but we will need time to progress that to the later stages and therefore, filling the gap will be an important one objective of the company and Bart will discuss more in that respect. With that, I would like to hand it over to our President and Chief Operating Officer, Bart Filius.

Bart Filius -- President/COO

Thanks, Onno. Good morning, everyone in the US. Good afternoon in Europe. Pleased to say a few words about the commercial performance of Jyseleca in Europe as well as on the financials, including some update on our cash burn guidance that I'll speak to in a few minutes. But first of all, Jyseleca in Europe, we are very pleased with how the launch is going in rheumatoid arthritis in Europe. Here on this slide, you see a view on sales, which is actually combined view of the sales booked by Gilead and Galapagos which we felt is the best way to show the performance of the products in the markets in Europe. So in grey, the sales are booked by Gilead, in orange, the sales are booked by Galapagos and that represents basically the handover of the commercialization efforts and the supply chain efforts from Gilead to Galapagos. A big chunk has happened in June, July and more to come by the end of the year. So there is still a little bit flowing through the Gilead P&L, but the vast majority is now on the Galapagos sites in orange. As you can see here the curve is going up with quite nicely in June, July, there was an exceptional stocking if you basically subject to roughly EUR1 million in June and added in July.

You see the curve lining up toward the September numbers. That's because of the handover in Germany specifically, we've made sure that the protocols that in good supply at the level of the wholesalers. It doesn't really affect at all our economics because obviously we are still sharing 50/50 all the profits and losses with Gilead in 2021. So nice curve upwards totaled $60 million year-to-date, of which $6 million is booked by Galapagos and we're happy with that trajectory. And then maybe on the next slide, a bit of perspective on the markets. First of all, this is EU 5 on the left, where we see the splits in the RA market between the anti-TNF class, the JAK inhibitor and the other biologics and we see a nice 17% share of the JAK class and still growing and that's across the five key countries in Europe. And then on the right, it's a graph that we've shown also when we did our Q2 results in August, the growing market share of Jyseleca. This is specifically in Germany, in all of the other countries, it's really too early days yet in France and UK we launched, I think it was June, July and Italy and Spain are just now going to be launched. So this is really focusing on our performance in Germany, where we're now, clearly you had a 4% of share of the dynamic markets.

So those are, those patients that are eligible for new prescriptions because of either switches for patients that are naive to therapy. So, growing market share there and we are pleased with our position. Also qualitatively on the next slides, we do our own market research, obviously where we are trying to see how the politics perceived both in terms of efficacy and safety, and we are really happy to see that despite the fact that we are in many countries just literally months into the marketplace, across the EU 5 we are really among the other JAKs in terms of efficacy and in terms of safety as well. So really being perceived at par with molecules that have been in the market for three, four years earlier. So, we are also happy with what we see in terms of the perceptions on the products. Then on the reimbursements we see progress as well and we are hoping to finalize the key parts of reimbursements this year. We're now in 14 different countries, that's all in dark green, there are some procedure still ongoing. As you can see here, Germany and Denmark and there are some submissions to be done still, but the key countries are there, the EU 5 is there, the Nordics, the Belgium and the Netherlands, Benelux countries are also fully reimbursed. So we're fully ready to roll with RA, with Jyseleca going forward.

And maybe last year also worthwhile mentioning is that we have signed a contract with a third-party distributor for Eastern Europe, Portugal and Greece, which we felt was the most operational savvy and economically logical thing to do for the promotion of Jyseleca in those territories. Then a bit on cash, we have an acceleration to reports on our savings program, you've seen the press release we are reducing our cash burn by EUR50 million coming to a level around EUR550 range between EUR530 and EUR570 and we were coming from a range between EUR580 and EUR620 and as a reminder that was already a reduction compared to will be initially announced in the year when we were still more in the area of around EUR680. So the big driver here is our cost reduction program that we've started to implement as of the results of the setback earlier in February and initially we had anticipated that we would materialize this year about half of that program or EUR75 million, we're not adding another EUR50 million to it. So we're making really good progress on that front, in cost savings.

In other words here on this slide still, it's a slide that I've shown before. But I'd really like to emphasize our cash burn is split up because on one hand, there is the R&D investments around EUR350 million currently. And on the other hand, there are silica investments, these are fully loaded costs, so that includes the sales and marketing expenses, but also G&A expenses and also the cost that we're running for trials such as diversity and all the long-term extensions on the initial trials. And we obviously anticipate to make the Jyseleca franchise breakeven in 2024. So the way to look at this from a cash burn point of view, as the company is progressing is that all things being equal, which we know they're not going to be, but all things being equal, the R&D sites and Jyseleca being at zero cash burn in 2024, we should be able to significantly reduce our cash burn annually. And then if you go to peak years, '27,'28 for Jyseleca where you actually anticipates to contribute significantly to our cash inflows. We should be able to significantly reduce our cash burn further. So we're in very good shape. I think from a cash burn point of view also in the medium and long term. Then a few words on the actual results.

First of all, in cash, EUR377 million is our cash burn for the nine months leading up to the end of September. As usual we exclude specific items such as the currency and the Fidelta proceeds and a little bit on warrant exercises as well and our total cash balance stands at EUR4.9 billion at the end of that quarter. On the key financials, more details obviously to be found in the reports and also happy to take any further questions but it's not highly eventful in terms of key financials. Perhaps, a quick word on revenue recognition. That's slightly more complicated this quarter as we had the diversity amendments. It's a bit technical, but frankly, what happens is that we are adding budgets to our total development costs for filgotinib and as a result the way we account for this on the IFRS percentage of completion is going down and technically as a result, our revenue recognition for the quarter was therefore reduced and that's a one-off effects that you see in Q3. That's why we're a little lower than our run rate of revenue recognition that you've seen in earlier quarters, but that should be moving forward, going to the normal levels.

And as those budgets evolves, as a reminder, if we are able to reduce our spend on our development budgets, we would actually get a positive effect on revenue recognition here because overall there's still EUR700 million on our balance sheets in terms of deferred revenue for filgotinib next to the EUR1.8 billion that is on our balance sheets in terms of deferred revenue. And on the rest of our platform, and that all combined EUR2.5 billion is still to be recognized over the next eight years. Their sales and royalties on Jyseleca and revenues as well. Operating costs are flat versus where we were year-to-date Q3 2020. That is basically on one hand, an increase in the commercial and G&A expenses on the other hand, it's a decrease in the R&D expenses. Last year we were ramping up throughout the year in terms of expenses. This year we are ramping down, but as a net results were more or less flat versus 2020. And then to get to the net loss, we this time have a financial income gain in currency and we have obviously the Fidelta disposal that we took in January as well. Moving to the outlook, a lot of the event that we were anticipating have indeed occurred and materialized. We discussed many of those.

Still to come, is the anticipated approval for [Indecipherable] by the European Commission and that is hopefully imminent. And then lastly, there is also the anticipation that we will have fully recruits, the mangrove trial with 2737 in polycystic kidney disease. Then maybe lastly, before we move over to the Q&A, a slide that we've been showing before really we are laying the foundations for future growth with the company, following our strategic review that we've done in March with 4 key focal points. First of all, on R&D continue to discover and develop novel targets. Our business model, there is unchanged, there is a gap in our pipeline, but we will progress our existing programs from preclinical to clinical and from Phase 1 to Phase 2 and hopefully in due course also to Phase III. So focus on R&D and focusing on the right opportunities there. The second thing that we want to get right is the commercial launch and that we spoken about that in some detail. And next year we will be adding ulcerative colitis to the indication.

So that's an extra challenge and the next opportunity for the company. On the BD front, no specifics to report today, but we are definitely very active on that front and we definitely want to bring in, let's say opportunities both in earlier R&D, as well as in commercial stage. So we're active in discussions on several opportunities and as soon as we've got something to report there, we'd be happy to bring that to the public domain. And then lastly our focal point on the financials. Clearly, disciplined cost savings is what we are executing on and all the time. Well as speaking to that searching for a new CEO and CFO and that announcements to be expected in the next months to come. With that, concludes, we're indeed 20 minutes over the hour. So roughly in the time that we were given by Sofie. I suggest we hand it back to Boston there and we start with the Q&A. Thank you.

Sofie Van Gijsel -- Director Investor Relations

Thanks very much, Bart. So this concludes the presentation portion of today's audio conference call and I would now like to ask the operator to open up the line for Q&A.

Questions and Answers:

Operator

[Operator Instructions] Our first question comes from the line of Wimal Kapadia from Bernstein. Please go ahead with your question.

Wimal Kapadia -- Bernstein -- Equity Analyst

Great. Thank you very much for taking my question. So I guess just one. Just curious to hear your thoughts on the recent failure of [Indecipherable] in UC and how that potentially changed your thinking about your own TYK2 program, if at all. Any read across, any comments would be much appreciated. Thank you.

Walid Abi-Saab -- Chief Medical Officer

This is Walid, I'll take this question. Good morning and good afternoon everybody. It's surprising actually for us to see these data because JAK2 inhibitors are expected to work in ulcerative colitis by inhibiting the signaling through IL-23 as you know IL-23 inhibitors demonstrated efficacy in [Indecipherable] colitis. Nonetheless, I think pertaining to the information that we know about [Indecipherable] and what's been shared by DNS it might be a question of dose. I think they mentioned that they have an ongoing another study where they evaluating a higher dose. We also know that in ulcerative colitis in general need a dose that's two to threefold higher than what works and other inflammatory conditions such as psoriasis in RA. So it's not surprising that that might be a question. In our case, we feel quite comfortable with the compound that we have, our select TYK2 inhibitor.

Right now we are finishing the Phase 1 studies as well the preclinical work that would enable us to chronic dosing and enable us to move into Phase II for psoriasis as well as ulcerative colitis. So we continue marching forward, if it's a matter of dose ultimately we just have to do the assessment of our molecule in these indications to see whether we have the necessary exposure to produce these effects because I don't think we question the mechanism of action here. It might be a compound specific dose limiting effect. Thank you.

Wimal Kapadia -- Bernstein -- Equity Analyst

Great, thanks very much [Indecipherable].

Operator

Our next question comes from the line of Dane Leone from Raymond James. Please go ahead with your question.

Dane Leone -- Raymond James -- Senior Biotech Analyst

Hi, thank you for taking the questions and updates on the progress. I guess I'll use my one question to ask this, has the Board and management going through the process of looking at new leadership and-or the way the companies to be run forward considered actually breaking up the company. We have a recent example Bluebird Bio splitting company effectively into a commercial asset and asset that is still in the development phase. Why wouldn't you consider that given, as you pointed out, have a big gap between filgotinib being a commercial asset and then a very early stage R&D portfolio where you get out two companies that have two different necessary skill set to run them maybe be more efficient on an operating perspective. So would appreciate your thoughts there. Thank you.

Unidentified Speaker

Yeah, thank you for the question. And of course this is in the scenario we have discussed internally as well. We think that keeping the two together makes most sense for Galapagos at this point in time, we believe that filgotinib is sound business case for us in Europe, it's looking positive although Of course, we have high start-up cost. We are convinced that we can turn this around into a profitable enterprise. We brought filgotinib to the markets, we are still planning to build a European commercial infrastructure with more than the filgotinib, of course, that has now caused a delay, with the delay in the further molecules coming through to the market that we think we can fill those gaps. So we believe that to bridge this, we rathere go into an BD M&A scenario rather than splitting up the company which would have been a quite a bit destruction of capital for Galapagos because it would be very difficult to retain the people that are currently marketing filgotinib in Europe. So we believe that keeping it altogether and fixing the problem that we currently have in the pipeline through an external acquisition as the best option to create shareholder value.

Operator

Our next question comes from the line of Jason Gerberry from Bank of America. Please go ahead with your question.

Jason Gerberry -- Bank of America -- Wall Street Analyst

Hey guys. Good morning. Thank you for taking my question. Just wanted to come back to the commentary about how you guys are evaluating BD and sort of juggling that in parallel with the CEO hiring decision sort of, are you guys aggressively looking at larger, more transformational type deals or just smaller type of transactions until you get a CEO in the seat? Thanks.

Bart Filius -- President/COO

Yeah. Hi, Jason. Bart speaking here. No, I think that's a great question and obviously pending a new CEO nomination, one should not expect BD which is completely different from the strategic direction that we've given to the company and that the Board has pointed out. So our focus in BD clearly is on the inflammation area or the fibrosis areas that we know very well and that we're committed to. And potentially on the commercial side, if there are opportunities for Europe specifically where we can leverage our commercial infrastructure a bit better. So I think it's really bolton transactions of that nature that we're looking for. But I think pending a new CEO nomination, you should not expect a large transformational deal that will completely change the course of the company or the size of the company for that much.

Jason Gerberry -- Bank of America -- Wall Street Analyst

Okay, thank you.

Operator

Our next question comes from the line of Rosie Turner from Barclays. Please go ahead with your question.

Rosie Turner -- Barclays -- Wall Street Analyst

Hi. Good afternoon. Thank you so much for taking my question. [Indecipherable] to ask. I guess, it will be useful to hear a little bit more about this partnership actually in Eastern Europe, Portugal and Greece, and economics you can give us around that and whether that deal will extending to UC as well. Thank you very much.

Unidentified Speaker

[inaudible], will you take that?

Unidentified Speaker

Yeah. So, I wasn't sure about the question. The question is about the partnership in the rest of Europe?

Unidentified Speaker

Yeah. Eastern Europe.

Unidentified Speaker

So, absolutely. So that's the decision we took to have that role with the company that have already infrastructure build there and it's about the whole internal pipeline of Jyseleca. It's about, relaunch of course and then will be extended in due time after approval to their indication so ulcerative colitis a constant that will allow us to optimize our P&L by course getting a boost in the top line without having to need to invest in operations there. Did that answer your Eastern question?

Rosie Turner -- Barclays -- Wall Street Analyst

Yeah, Great. Thank you.

Operator

Our next question comes from the line of Mathhew Harrison from Morgan Stanley. Please go ahead with your question.

Matthew Harrison -- Morgan Stanley -- Managing Director in Research,

Great. Good morning, thanks for taking the question. I guess I was just curious if you guys have any interaction with AbbVie related to the CF program or have any idea of what's going on there and any thoughts on the outlook for that. Thanks.

Onno van de Stolpe -- CEO

I'm Onno. Of course, we have a bit of an idea of what's going on there. We get updates from AbbVie on a 6-month basis, but they're quite brief, so not a lot of detail, so we don't know much more than you know from what AbbVie has published. The good news is that AbbVie is talking about the same numbers of molecules, the Galapagos numbers that were part of the collaboration as being part of their typical if that is true, then that's good news for Galapagos if it ever reach market because as you know, the royalties are linked to the number of molecules that are in the triple combo. We have a basic loyalty and then add royalty percentage based on one molecule and a percent based on the second molecule. So yeah, we hope that 2 of the 3 molecules come from our stable, but we have no confirmation from AbbVie in that respect.

Operator

Next question comes from the line of Steven Duong from RBC Capital Markets. Please go ahead with your question. Steven, you might be on mute, can you mute yourself, please.

Steven Duong -- RBC Capital Markets LLC -- Analyst

Thanks for that. This is Steve Duong. Onno, can you share with us any additional insights alluded to preclinical safety of the Toledo molecules and whether you have any greater clarity on the relative compound specific versus target specific safety touched us of the and tolerability there. Thanks.

Onno van de Stolpe -- CEO

Well, thanks, that's a good question. I want to refer to what we shared on the to the profile of the triple combo as we before and in principle we never share details on specific organs of any kind. So we are pleased with the profile we've seen. We have sufficient margins and they have allowed us to move the first combo into Phase II, we have another one in the Phase 1 and based on what we've seen. We hope to with the NEX compounds, I suppose, especially focus to hit the targets harder and as well to come up with selective as in Q2 and so and selective as in Q3 to get the combined. So these are the 3 axis we follow up today, the profiles make us comfortable to play on those three axis.

Steven Duong -- RBC Capital Markets LLC -- Analyst

Thank you.

Operator

Our next question comes from the line of Peter Welford from Jefferies. Please go ahead with your question.

Peter Welford -- Jefferies & Company -- Pharma & Biotech Research Analyst

Hi, thanks for taking my question. Can I just ask just regarding the costs and the force brand. When we think about the sales and marketing spend, should we consider the current sort of run rate, is going to modestly increase going into 2022 given I guess you already beginning to take on full control from Gilead or will there be a further brand as we consider the UC indication and perhaps you can give us some sort of idea of what you're thinking regarding the incremental I guess head count that could be needed to UC and that's if could but I just point of clarification, just on the CEO search you're doing. Could I just ask, is the criteria for the CEO such a scientifically focus, CEO. When you talk about BD in the pipeline, so the bar retains into the CFO commercial role or is a much broader search for a CEO and we shouldn't limit ourselves that sort of thinking when we think about the Board's search for replacement. Thank you.

Bart Filius -- President/COO

Hi, Peter, it's Bart speaking. Let me take the first point on the cost and then maybe Onno can say a few words about the CEO search question. So I think with regard to where we are now in terms, organization, there is a slight ramp up, still to be done on UC and there's also some country transfer still to be done from Gilead to Galapagos but it's not huge anymore and so I think we're at a run rate as to be anticipated. But one word of caution is that we are next year no longer sharing our expenses and our results with Gilead 50/50 but we're taking on 100% of both the top line and the costs. So, we'll give a bit more detail for your expectations for 2022 when we do our results announcement in February as usual, because on one hand, we're going to see ramping up revenues on the other hand, we're going to see this cost share changing from this year to the next. Net-net, all in all, I do not expect it to be a major deviation from where we are this year in terms of costs.

Onno van de Stolpe -- CEO

Yeah. Regarding the CEO profile, clearly it we have already communicated that it has to be an individual with a strong R&D background and that is important for the future of the company, we have the partnership with Gilead, we got EUR5 billion in the bank to bring novel molecules into the clinic. So we wanted or the Board wants to CEO that can really guide that process and take strategic leadership there. But on the other hand, it's obvious that with a company that has a product on the market that is looking for strategic BD activities, we need somebody with the right experience and the right weight in that area as well. So I think all in all, this is going to be a very seasoned executive, clearly with somebody who has her or his feet very strongly in the research, because that is something that remains at the focus of this company.

Operator

Our next question comes from the line of Steve Nadeau from Cowen, please go ahead with your question.

Philip Nadeau -- Cowen and Company -- Mng Dir:Biotechnology Health Care/Sr Analyst:Rsch

Hi. This is [Indecipherable] sale, and thank you for taking our questions. Still for us, Stolpe, I wonder if you could provide some color into the next generation Toledo compounds. Any updates on the development from that, are you still expecting for a candidate to [Indecipherable] in 2022 and why you're looking for. And then the second thing is, in terms of Jyseleca potential in IBD in the US, can you provide some color in your strategy of discussions given that we've done the results of MANTA and MANTA recently studies available? Thank you.

Unidentified Speaker

So should I take the first question then I will pass it on? Yes, I think Peter has answered some of it before. So, as you know, our first foray into that space was 39.70 and we were pleased to see evidence of clear clinical activity in psoriasis and biological activity in UC but what was clear to us from looking into these data is that we need to inhibit these enzymes for a longer period of time and that's currently what we're working toward. That's one of the [Indecipherable], with this (SIK) 2/3 inhibitor to come up with compounds that will enable us to inhibit these two enzymes throughout the day for longer period of time, so that we can fully test the potential in these indications. In addition, also, there is a lot of learning that's happening with these whole platform and we at Galapagos are at the forefront of elucidated the role in inflammation, which we're very proud of. But that will take also time and diligence effort to be able to get selective compounds. We have one, which is the (SIK)3 inhibitor, currently in the clinic, and that will derive a lot of information and tell us the way forward in that space.

In addition, as Peter also mentioned another major axis is for us to work on generating (SIK)2 inhibitors and those are still in the research phase, but hopefully will go into the clinic. So in terms of the way forward, there's going to be a lot of analyzing of the data that we have preclinically but also clinically with 3970 and soon with, 4399, which is basically inhibitor and doing sort of the forward and back translation, so to speak. Bench to bedside and bedside to bench so that we can better position our molecules going forward. For this coming year, we expect to have at least a (SIK) 2/3 inhibitor into the clinic in Phase 1 and be able to better test the hypothesis whether inhibiting those two enzymes will provide better efficacy enough that the and going indications.

Bart Filius -- President/COO

Yeah, let me take the second half of the question with regard to Jyseleca in the US. I think with the EU with excluding the class has come under in the US, it has become increasingly unlikely that Gilead will be launching Jyseleca in the US markets. Obviously, there is still an important study the grown study II readouts and that will come once it's early 2023. But honestly I think we're focusing very much on Europe and some other territories in the rest of the world, but I think the chances of Jyseleca reaching the market are very slim.

Operator

[Operator Instructions] We have a follow-up question coming from the line of Rosie Turner from Barclays. Please go ahead with your question.

Rosie Turner -- Barclays -- Wall Street Analyst

Hi, good afternoon. Again, I'm just thinking about UC I guess in terms of and the hopefully upcoming approval and then launch. What are the kind of economies of scale of already having your approval and does that actually mean, I guess we're now rolled out in 12 countries. Is that going to be a quicker process, a second time round? Thank you.

Michele Manto -- Senior Vice President Commercial Operations

Yes. This is Michele, I'll take this question. So definitely when we built the countries in the past months and their organizations therefore, we already thinking ahead for the addition of UC. So we did an evaluation country by country, and together with external help of experts and consultants to find the most efficient and effective operating model for each country. Which in a way, allows us to flexibly add personnel sales for medical organization to address that additional target group of the gastroenterologist of course doing in a way, which is efficiency in some countries will add some parallel forces to the existing RA in some others will enlarge the scope of activity, of the hematology team to also address that. And that's very good because this makes us efficient country by country looking at the different systems right there. There are countries like Germany which are office based in countries like France, which are hospital based where all the prescribers are in the same building, in the same place both rheumatologists and [Indecipherable]. So in that way, we have already started, of course, hiring where we need and diligently also considering the different reimbursement time. So we are ready to go say in Germany and will take more time in Italy or Spain, where the reimbursement takes a year longer standard in the industry.

Rosie Turner -- Barclays -- Wall Street Analyst

Perfect, very clear. Thank you.

Operator

We appear to have one question that just got registered. It comes from the line of [Indecipherable] please kindly ask your question.

Unidentified Participant

So thank you for the chat this far and the information. Maybe one question surrounding Jyseleca. Can you provide some further insight on what the physician and then feedback is on the product this far specifically in Germany. Any specific things need to be aware of, how do they look at it compared to their peers and other specific patient populations, for which it is, let's say, more appropriate?

Michele Manto -- Senior Vice President Commercial Operations

Yes. Here Michele, again. Thank you for the question. So the feedback we're getting is consistently positive on the profile and the efficacy and safety profile we have and actually the referencing back to the JAK1 preferential features that we had, and actually that has become a clear reason to believe about the differentiating profile. Would you have actually recognized in the market research of the lives that part presented earlier in the prepared remarks and it is recognized in Germany and in the other countries, but that's very comforting because this set the base for the continued performance of Jyseleca even in the current situation with the JAK class, but it's a good point of differentiation and positive comfort. In terms of experience, we also getting that back from physicians, they see the rapidity of effects, the speed of effect. And also in the patients that are already for a longer time on the drug. So say one year in Germany as we announced a year ago. Also there persistency persistence of effect. So consistently with the expectations we had at launching with the position that we have executed across the geography.

Operator

That appear to be the last question coming from [Indecipherable] who's from KBC Securities. We appear to have no further question at this point. So I hand the conference back to Sofie.

Sofie Van Gijsel -- Director Investor Relations

Thanks so much, operator. So this concludes the Q&A portion for today. Please feel free to reach out to the IR team if you still have questions. Our next financial results call will be our full-year 2021 results on February 25th of next year. Thank you all for participating today and have a great rest of your day.

Operator

[Operator Closing Remarks]

Duration: 45 minutes

Call participants:

Sofie Van Gijsel -- Director Investor Relations

Onno van de Stolpe -- CEO

Bart Filius -- President/COO

Walid Abi-Saab -- Chief Medical Officer

Unidentified Speaker

Michele Manto -- Senior Vice President Commercial Operations

Wimal Kapadia -- Bernstein -- Equity Analyst

Dane Leone -- Raymond James -- Senior Biotech Analyst

Jason Gerberry -- Bank of America -- Wall Street Analyst

Rosie Turner -- Barclays -- Wall Street Analyst

Matthew Harrison -- Morgan Stanley -- Managing Director in Research,

Steven Duong -- RBC Capital Markets LLC -- Analyst

Peter Welford -- Jefferies & Company -- Pharma & Biotech Research Analyst

Philip Nadeau -- Cowen and Company -- Mng Dir:Biotechnology Health Care/Sr Analyst:Rsch

Unidentified Participant

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