Good day and welcome to the Galapagos Half year results call. At this time, I'd like to turn the conference over to Miss Elizabeth Goodwin. Please go ahead.
Thank you all for joining us today for the audio webcast of Galapagos's first half 2020 results. I'm Elizabeth Goodwin, Investor Relations, also representing a great reporting team. This recorded webcast is accessible via the Galapagos website homepage and will be available for replay later on today. So that your questions can be included, we request that you call in to one of the telephone numbers given in last night's press release. I've got one for you here, thirty two for Belgium, two four zero four-zero six five nine with code eight nine nine seven seven one zero. I'd like to remind everyone we'll be making forward-looking statements during today's webcast.
These forward-looking statements include remarks concerning future developments of the pipeline in our company and possible changes in the industry and competitive environment. Because these forward-looking statements involve risks and uncertainties, Galapagos's actual results may differ materially from the results expressed or implied in these statements.
Today's speaker will be Onno van de Stolpe, CEO, as Bart Filius is away. Onno's going to go through the operational highlights and explain the financial results and expected future news flow. You'll see a PowerPoint presentation on screen. We estimate that this will take about 10 minutes. Then we're going to open up the call for questions with Onno, who will be joined by Walid Abi-Saab, our CMO, Piet Wigerinck, CSO, and Michele Manto, who's our Chief Commercial Officer. Now I'd like to hand to Onno. Go ahead, Onno.
Thank you, Elizabeth, and thank you all for attending this webcast. I hope you're all enjoying the summer. A weird summer in view of COVID-19, but we're all making the best of it. We're all dispersed in various locations today, so hope the logistics go well. Yes, let's start with a very positive note on the positive CHMP opinion for filgotinib in rheumatoid arthritis. Of course, a hallmark moment for Galapagos, our first molecule that received a positive CHMP opinion. We're very pleased with the progress we're making to get filgotinib introduced into the market. This opinion is a recommendation for marketing authorization in Europe for treatment of moderate to severe rheumatoid arthritis patients.
The very good news is that we got both the 100 mg as well as the 200 mg dose recommended, which will give an option to doctors to prescribe a lower as well as the higher dose, which we believe is a benefit for this molecule. The patients that will receive filgotinib are those patients who have inadequate response or intolerance to one or more DMARDs and monotherapy or in combination with methotrexate which was as expected in the recommendation. We're very pleased with that recommendation. All of this is based on the FINCH and the DARWIN data, the phase III and the phase II data set, that in total included 4,500 patient-years experience. There's a lot of efficacy and safety data on filgotinib with the regulators. We're now awaiting the EU marketing authorization that normally should come in a two-month period.
If we look at how we are approaching this in the commercialization, clearly we will start in a limited number of countries. Gilead will have the remainder of Europe to introduce filgotinib in RA. Galapagos will do this in the Netherlands and Belgium, as well in France, Italy, and Spain. Quite a large geography where Galapagos is responsible for the full marketing and commercialization of filgotinib. We're also expecting that later we will also get authorization to market filgotinib for IBD, inflamed bowel diseases. In that case, we will be marketing that in Belgium, the Netherlands, as well as the U.K. and Germany. Different geography than for rheumatoid arthritis.
The big advantage for us is that we can gradually increase our marketing efforts and footage in Europe, preparing for a full European presence on the commercial side for our next product that would hit the market and most likely, that should be our product for idiopathic pulmonary fibrosis, ziritaxestat. For now we're ramping up for the first product launch for filgotinib in those five territories, which we believe is a great challenge, but we're very well ready to take on that challenge and we're very well prepared. With that, we go to the next slide. Let's spend a couple of minutes on the SELECTION Phase III results in ulcerative colitis with filgotinib. Clearly, we saw very good data coming out of this trial. We hit the primary endpoint both for the 100 mg and the 200 mg on EBS remission at week 10 and 58.
With the 200 mg, we achieved both the induction as well as the maintenance endpoints. The 100 mg achieved the maintenance endpoint but not the induction endpoint. It was a tough population to treat these patients. We were very pleased with the outcome of this trial. If we looked at the safety side, the rates of serious adverse events were low and very comparable across the treatment groups and in line with what we have seen with other trials in rheumatoid arthritis and other indications. The full data will be presented at a future medical conference in collaboration with Gilead, obviously. That's for the science and development part. Let's switch to the financials. Normally, Bart would have presented that, but I'll try to do it as good as I can.
We started the year at EUR 5.8 billion, the big cash burn this year on the operational side reduced that with EUR 230 million, completely according to plan. We ended the first half on a cash pile of EUR 5.6 billion. That was completely in line with the expectations. We can go to the next slide. You see the financial highlights. We see the revenues going up substantially compared to a year ago. We had an extra EUR 160 million, which landed the revenues at EUR 224 million. Having said that is, of course, the consequence of the big deal we signed with Gilead, where we have revenue recognition on the technology access that they receive through the option agreement and the upfront that they paid, and that is recognized over a 10-year period. That brought us to the total revenue of EUR 224 million.
Operating costs went up substantial with EUR 150 million, and that's because we are expanding in all areas, being it development, research, G&A, and also, of course, the preparation of commercial launch, which starts to kick in seriously on the financial side. All according to plan, and we're very pleased with how that is all coming along. That combined led to a net result of a loss of EUR 165 million compared to a loss of EUR 17 million last year. That, of course, is a consequence of the substantial increase that we're doing in the various aspects of our business. Nothing to be concerned about. It's as we had previously communicated to the market that we would ramp up pretty much all the expenses in research, development, and commercialization.
If you go to the next slide, we reiterate our guidance for operational cash burn of EUR 400 million-EUR 430 million, and that includes EUR 205 million in potential milestones subject to regulatory approval. Those milestones have to come in to enable us to keep that cash burn. If the milestones, for whatever reason, would not come in this year, then clearly, we would have a higher cash burn than the EUR 400 million-EUR 430 million. The last slide is about the milestones that you can expect for the remainder of the year. We have the SELECTION data come in. We are now awaiting three phase II readouts, two phase II-A and one phase II-B. The first one, PINTA study, is in idiopathic pulmonary fibrosis with GLPG1205. That data we are expecting shortly. We have the second indication for GLPG1690, ziritaxestat. The first indication, as you know, was in IPF.
The second indication, this is in systemic sclerosis, where we're getting that data in the NOVESA trial, also in the upcoming month. Also the long-awaited and important trial of GLPG1972 in the ROCCELLA trial, which is in osteoarthritis, which is a very large trial of over 800 patients that we're doing together with Servier. Also that data set should come in the remainder of the year. Everybody is awaiting the anticipated regulatory decisions in RA, being it in the EU, following the CHMP opinion, as well as the FDA and Japan. All three of them should come in the coming months, and we should know how we're going to market filgotinib based on those decisions. With that as an introduction, I'll hand it back to Elizabeth to take the Q&A.
Okay. Thanks, Onno. That does conclude the presentation part. Questions will now be taken on a first-come, first-served basis. You know we don't manage the queue. Please limit yourselves to one question per caller today. Now I'd like to ask the Operator, Jennifer, to connect us to anyone with questions for the team. Go ahead.
Yes. If you'd like to ask a question on today's call, that is star one on your telephone keypad. We'll go first to Rushee Jolly with Bernstein.
Hi, Rushee Jolly, Bernstein. Thanks for taking my question. Do you expect a warning on the filgotinib label for testicular toxicity? If there is such a warning, how quickly would you be able to remove it from the label post MANTA data? What impact could you see on uptake as a result of that? Thank you.
Maybe I'll address the regulatory question and then turn it over to Michele. This is Walid.
Good morning and afternoon to those folks on the phone. I'm assuming you're referring to the European label, because we don't know anything about the U.S. yet. I think the MANTA data or MANTA studies are meant to evaluate whether we see any evidence of effects in humans based on the sperm safety or sperm toxicity and these endpoints that we use. Those data will be very important to inform, actually, on any potential risks to humans. As soon as we have those data, we will be submitting them to the CHMP and discuss with them the way they will be implicated in the label. We believe that this is the right study to be done, and those are the results that will truly inform about the potential risk, if any, to humans. I'll turn it over to Michele regarding the uptake question.
Yeah. Based on what Walid said, the driving force will be the label. Of course, we have confidence, but there's no one to speak with now. We also know that the rest of the profile of filgotinib has strong values and strong points to make a good launch.
Perfect. Thank you very much.
We'll go next to Debjit Chattopadhyay with H.C. Wainwright.
Hey, good afternoon. In the SELECTION study, male patients on the 200 mg dose had both a TNF and vedolizumab, which lowers their placebo-adjusted rates to between 8% and 11% range. Well short of clarity on how women might have fared and if these rates are comparable. Thank you.
Yeah, thank you for the question. You broke up a little bit, but I assume you're asking whether there's any difference between males and females in the trial. I'll be honest, we haven't yet disclosed those information. As you know, we plan to present the details of the SELECTION trial at an upcoming scientific conference, and then we can go into the details of the breakdown based on previous treatment, vedolizumab, TNF, failures on both, and how do they compare to the others, as well as male, female, and age. At this point, I can tell you, I don't have any unusual results, and maybe I'll leave it at that, and we'll have to see it when we present the data at an upcoming conference.
Suffice it to say that in this trial we had, and I think Onno alluded to that, we had, as you can imagine, a higher number of people who have been exposed to two different types of biologics, TNFs and vedolizumab, and we have a significant number of patients, close to about 50%, who actually got exposed to both, not just one or the other. We are looking forward to sharing those data with you at an upcoming scientific conference. Thanks.
Thank you.
We'll go next to Evan Seigerman with Credit Suisse.
Hi, guys. Thank you so much for taking the question and congrats on the progress. As we head into the potential launch of filgotinib in the U.S. and Europe, can you just review some of the pre-commercial activities you're engaging with, especially in Europe, given how competitive the space is? Any points of differentiation? I know it's a common question you get a lot, but it's a question I get a lot as well. Thank you so much.
Yes. Hi, this is Michele. Thank you for the call. First thing for Galapagos, of course, was to build up our presence and operations, as Onno highlighted in the slide earlier. We are very happy with the progress we are doing with that. First thing, of course, being the recruitment of the team. We are recruiting really strong talent, coming with experience in RA and respectively in IBD already in Germany and U.K., who really have already strong contacts with the customers, know the market, and at the same time, also experts in medical and access. As you can imagine, our first actions are, of course, in tracking and planning the best and most effective way to achieve reimbursement and also setting up the contacts in the compliant way that we can have before the actual approval of filgotinib.
I would say despite also the COVID-19 situation, we have strong contacts, strong first outputs, connections with the experts, very strong also feedback, and expectation about our upcoming launch. As you might also have observed, had a very strong presence at EULAR in a virtual way. It was also a way to test our virtual capabilities given the uncertainty on the future scenario. We did that together with Gilead, our presence there at EULAR was top level with the top leaders in rheumatology. Thanks for the call.
Great. Thank you so much.
We'll go next to Brian Abrahams with RBC Capital Markets.
Hey, guys. Thanks for taking my question. Coming out of the SELECTION study, I was wondering if you could talk a little bit more about the status of regulatory engagement, and maybe your expectations for the GI division's view on MANTA and MANTA-RAy, what they might look for there, and your confidence that this division would be amenable to a broad label, I guess at least in ulcerative colitis including the 200 mg dose, just given the limited number of TNF-naive male patients that were enrolled in the U.S. at that dose. Thanks.
Yeah. Thanks, Brian, for this question. Yeah, tough to answer. I can tell you that we in Gilead are preparing for submissions. Not just the U.S., also Europe and Japan, for ulcerative colitis. We cannot give any color as to where the agencies sit on this. It would be speculation at this point. I think suffice it to say that we are quite confident with the data that we have with filgotinib, with the totality of the safety data that we've seen, both from the rheumatoid arthritis but also the IBD data. I cannot speculate on where the agency would sit and about approval on the 200 mg. We're going to have to wait a bit longer for that. Thanks.
Okay, understood. Thanks.
We'll go next to Jason Gerberry with Bank of America.
Hey, good morning. Thanks for taking my questions. My question just on Toledo. When you look to initiate your proof- of -concept trials in the second half, I know that the plan was to initially evaluate ulcerative colitis. Just wanted to confirm that, will you be conducting trials in other populations or is that going to be strictly limited to the UC population? Thanks.
Jason, Piet here. Thanks for the question on the other pipeline. No, for the Toledo program, we remain as ambitious as we've been before. GLPG3970 is going to be explored broadly, and we'll have different waves. We'll start with wave one, which will have three PoC studies, and then will come wave two, which has longer studies, and then a wave three, which is on the more chronic indications. We remain with our ambitions, and we plan to start in second half if COVID allows, a different number of clinical studies there. Thank you.
We'll go next to Matthew Harrison with Morgan Stanley.
Hi, all. Thanks for taking the question. This is Connor on for Matthew. Just two quick ones from us. Can you comment on the enrollment speed in the IPF studies and if they remain generally on track amid COVID, and on track for the futility analysis? You noted in your press release, pending successful start of the Toledo studies, you plan on providing more information. We were just wondering if you could provide more information on what kinds of impacts you're seeing and the potential for a delay on those, given COVID. Thank you.
All right. I'll take the first question. This is Walid. I'll talk about the ISABELA program. As we've discussed before, in the ISABELA program, just like virtually everybody, COVID had an impact on these trials and enrollment. That impact actually has not been consistent and uniform across the world, but it comes in waves, and I think it follows, to a great extent, the pandemic that we are continuing to live through. We have seen a return towards normal in the studies that we have and the recruitment, and we feel confident that we should be able to finish recruitment sometime in the first half of next year. The futility is still on track to be conducted also the first half of next year.
While the situation is fluid, as you know, with that caveat in place, currently, we feel optimistic that we are starting to see a pickup. Maybe less so in certain parts of the U.S. and mostly in Latin America. The rest of the world, I think we're seeing a return gradually towards normal. Not fully there yet, but on our way.
Thanks, Walid. I'll cover the question on the COVID-19 impact on the Toledo study. The challenge there was a bit different in the sense that we had to start up those studies, and during the first wave, especially the countries where we've planned to start up those studies, we simply could not get to the hospitals, and they were not ready to initiate any clinical studies. That's now over. Our current view is that we will be able, and that's out of our direct contacts with the involved sites, that we'll be able of starting up these studies in the second half of the year. We are ready to kick them off. Of course, we hope that there is not a second wave that paralyzes the whole medical system again, but we don't think that's going to happen.
We are confident today that we will start up those studies in the second half. Thank you.
Thank you.
We'll go next to James Gordon with JP Morgan.
Hello. Thanks for taking the question. James Gordon, JP Morgan. My question is actually a finance one on OpEx. OpEx was about EUR 200 million when you reported last night, annualizing at about EUR 800 million. If we look into 2021, presumably quite a bit of ramp-up in sales and marketing and also lots going on in the pipeline. For next year, could OpEx significantly exceed this sort of higher annualized 2020 figure, or is this somewhat exceptional for this quarter?
Well, we haven't given guidance yet on 2021, clearly. This is Onno. Thanks for the question. It's clear that our costs are going to increase with regard to the ramp of commercial, especially as we are ramping up for IBD. Of course, also our trials continue to mature to a later stage. We'll be doing more phase IIs and hopefully more phase IIIs, the costs are going up. On the other hand, we will see our first commercial sales coming in. We see revenues coming in. We have further milestones coming in with regulatory approvals. It's pluses and minuses, in general it's clear that 2021 is not going to be financially a year where we will be moving closer to a break-even or profit situation.
Thank you.
We'll go next to Lenny Van Steenhuyse with KBC Securities.
Hi, good afternoon, everyone. A question on the commercial side from my end. We've seen AbbVie being able to ramp up RINVOQ sales quite impressively last quarter. Of course, there the main focus lies in the U.S., while you yourselves, apart from Gilead, will be commercializing in Europe. I was wondering, how do you think about differences in competitive pressure in these two regions? Are there any specific dynamics that are unique between each market? Do you believe a higher or lower market share is possible versus Europe or U.S.? Can you give a bit of color on that?
Yeah, thank you for the question. This is Michele. Of course it is also a very unique time to look at uptake course with the COVID pandemic ongoing. That of course affects the number of patients being treated, being started. That said, of course, we're looking at it and looking at the geographies. Our focus is on Europe specifically and frustrated the strength of Gilead to do a great launch in the U.S. and prepare for it. The difference of course, if you can look at, is how, for example, OLUMIANT and XELJANZ launch also in Europe and we've seen there also strong uptake. We have already 15%+ from those two products and becoming JAK the next mode of action after anti-TNFs. In the U.S., the success of RINVOQ, if you want, that way testifies the need for patients for new oral therapies that are there.
That creates also base for new JAK launches, and that's very important as well. The other element that's also very reassuring for the need of JAKs is the fact that all across the geographies, JAKs are being used also in first line, so in bDMARD-naive patients, whereas in later years the thought was only to limit the use in TNF failures, and that also creates another need, another platform for successful launches. Thank you for the question.
Thanks very much.
We'll go next to Emily Field with Barclays.
Hi, I just had a quick follow-up on the question on OpEx. I couldn't quite hear the last comment you made on 2021. Did you say that that will be progressing towards break even? Just if you could clarify what you said. Then my second question was, I believe this would be for Walid. A competitor recently showed very compelling data in psoriasis with a IL-17A and F inhibitor and has expressed optimism about that mechanism of action in psoriatic arthritis and ankylosing spondylitis, given the potential beneficial impacts on joint inflammation. I was just wondering if you could comment on why you think that JAKs will be a particularly compelling mechanism action in those two indications. Thank you.
Okay, I'll give Walid a second to think. I'll start. What I said, and maybe it wasn't clear to hear, is that because of the substantial increase in cost next year related to commercial as well as to our pipeline progression, we're not expecting that we will be moving towards break even. You can assume that our cash burn will at least be as high as this year. Yeah. Walid.
Yep. Thanks, Emily. Look, I think, the data that we have currently with the JAKs, based on the way we know the mechanism of action is in RA and also our initial data in psoriatic arthritis, including also our competitors, tell us that we have a very good efficacy there. Whether or not the competitor will have similar efficacy, less efficacy, a slower onset of action, those are things that will remain to be seen when we have those data. Theoretically, one can come up with a variety of hypotheses, but at the end of the day, we just need to look at the data. Speed of onset, magnitude of effect, but also sustainability of effect.
Those things we have seen very nicely with our own filgotinib, with the EQUATOR study and also the long-term extension that we've been publishing data on to see how nicely the efficacy has been maintained and sustained. Also, we've seen some data also with other JAKs that show very good effects in psoriatic arthritis. We're very confident that we'll be very competitive in that space. Thank you.
Great. Thank you.
We'll go next to Benoit Louage with Degroof Petercam.
Hello, good afternoon. Thank you for taking my question. Maybe just a small one from my side on the SELECTION trial. Just maybe to verify, so the submission for filgotinib in UC, that would still be planned for this semester, or would it be more in 2021? Thank you.
Usually, submissions for another indication will need to wait for approval in the first indication. This would be then dependent on, for the U.S., what's happening with the RA. For Europe, I think now the path seems to be clearer. Usually, we should expect an opinion from EU that follows the CHMP advice. Again, they have the prerogative to change their mind. Assuming that they were going to go down that same path, we would expect that to still happen this year. Similar for Japan, we still are on track, but first we need to hear on the primary indication before we move forward.
Thank you.
Thank you.
We'll get next to Dane Leone with Raymond James.
All right. Thank you for taking the questions, and congratulations on the progress. I just wanted to actually focus on IPF. Could you just, one, set the table for us a bit with PINTA and what you're expecting on that readout? Any color on your thoughts around what we had seen historically with the ProMetic asset with a similar mechanism. Secondly, we get asked the question on the stat plan for ISABELA a lot around the futility analysis. Could you just update us, remind us of the particulars of the stat plan for that futility analysis? Thank you.
Let me start with the ISABELA stat, and then we'll see who will take the PINTA question. The plan for the futility is, as we mentioned, I've discussed it before. The idea is that we wanted to make sure that we will not continue in a very long and massive program if the results from the FLORA were sort of a fluke, for lack of a better word. This is how we designed the futility analysis. We needed to have data from approximately a third of patients actually in each trial. This will translate into 70% information because we take the information from those 30% who have completed 52 weeks, plus all the others until that point. We have our various degree of involvement there. With that, we will estimate the difference between drug and placebo on the FVC annual rate, so 0 - 52 weeks.
Our objective that, if both doses in a given trial do not show separation from placebo or we have confidence that they're not going to be separating from placebo, then we will stop that trial. It's meant to really protect us against exposing a lot of patients to an ineffective drug, and that's what's driving the futility analysis. I will ask also, maybe, Piet, do you want to tackle the PINTA question or do you want me to do that?
I can do PINTA. We are pleased that the study is fully recruited. We are awaiting the results. It's a bit of a different design compared to FLORA in the sense that we have a mix of backgrounds there. We have the patients on nintedanib, about 1/3, 1/3 on pirfenidone, and about 1/3 on a local standard of care, which is different from one of those two because they are not available. In that sense, PINTA has a design which is similar to the ISABELA, but it's a phase II PoC study, much, much more. It's a 24-week study. In that sense, we hope that second half we can come out with a positive study, which will allow us to immediately start on top of each.
We will get a view how this compound behaves on top of those three medications, and if data are okay and not different for any of the backgrounds, that would be a clear path to progress into next phase of studies as we hope for. There's been a competitor which shows efficacy on one of the backgrounds, on nintedanib, but that did not show efficacy on pirfenidone. We don't anticipate to see such end results, but you can never exclude any of those. Thank you.
Okay. Was there something specific about the mechanism of the ProMetic asset that you think your team has engineered differently? Sorry, that was the last part.
Well, yeah. If you look to the two compounds, ours is specific GPR84 antagonist. Their claim, the compound is a dual. It's hard to compare the compounds. While ours is a classic, very potent, selective small molecule, their compound is weakly potent and touching a couple of targets. We've in fact never been able in our experiments to confirm a GPR84 antagonistic activity. I'm not going to say that it doesn't work like that, but it's a complete different type of how it modulates the target. That is clear. We are hopeful and confident that in PINTA, we will show that a GPR84 antagonist can show and will show good activity in IPF patients. Thank you.
Great. Thank you.
Okay.
We'll go next to Phil Nadeau with Cowen and Company.
Good morning. Thanks for taking my question. A question on GLPG1972 clinicaltrials.gov lists the study as completed as of mid-July. Should that imply to us that we're going to see data over the next several weeks to month? Secondly, can you talk a little bit about the primary endpoint in this study? How is the study powered on its endpoint of cartilage thickness at the cMTFC? What's a clinically meaningful difference on that endpoint? Thank you.
Thanks, Phil. Walid. Indeed, the study is finished, and we are in the process of doing the data cleaning and locking the database and with all the difficulties that you now face because of COVID. As you can imagine, visiting the sites and doing closing of queries and stuff like that are a bit more challenging than usual. We're still on track to have the data in the second half of the year for the study. In terms of how the study was powered and the primary endpoint, the study is powered using MRI, as a primary endpoint. The MRI will measure cartilage thickness in the medial portion of the knee. We follow a very rigorous algorithm that is automated. We work with sort of the best imaging groups out there.
We've learned a lot also from a lot of studies that we've conducted in the field, particularly with sprifermin, where they have a very large database. The way we powered our study is to be able to detect a reduction in cartilage loss by about 75% over a year period. Essentially, people who have a certain degree of knee osteoarthritis, use on average about 100 microns over a year, and you can measure that very accurately actually with MRI. With the variability that we expect, we powered the study to be able to detect a difference between drug and placebo when we reduce this by about 75%. You asked a very important question, what is the clinically meaningful effect? Actually, the simple answer is, and honest answer is, we don't know. Simply nobody has demonstrated these kind of changes and linked them to clinical meaningfulness.
This is one of the opportunities and also challenges of being at the forefront and treading into uncharted territory. We look forward to get the data and see how these will match and align with some of the very important endpoints that we measure, including pain, including function. We will work with our experts to be able to interpret this. Also we work with health authorities to figure out how we can design the subsequent trial to demonstrate indeed, that the changes that we see are clinically meaningful to these patients. A very important question, but it's a question that unfortunately today we don't have an answer to. We are working with the right people externally and also the regulators to better understand what that means.
That's very helpful. Thank you.
Thank you.
We'll go next to Laura Sutcliffe with UBS.
Hello. Thank you. On MANTA and MANTA-RAy, you've mentioned your plans today and previously to share the data from those trials with regulators. Will you ever make the data from those trials public? Thank you.
Yeah, good question. I don't think we have specifically discussed this with Gilead, but honestly, I think judging from the way we operate and the way they operate, these are very important data. I think the scientific community also would be very interested in it. I'm not going to go out and commit before getting that okay from Gilead, but if you ask me, I think there's no reason why we would not. Actually, I think it's our obligation to the patients who took part of the trial, to the community, to be able to share the data. I think that's probably what we'll do. I don't have a fully confirmed answer, and ultimately, this is their decision, so I'm going to not go beyond this in promising that we will share the data. Thank you.
We'll go next to Graig Suvannavejh with Goldman Sachs.
Great. Thank you for taking my question. I just wanted to talk about the PINTA study and what you're looking for in the phase II-A results for that asset. I'm curious, is the bar for success what you saw with ziritaxestat? Do you need for the data to be as good as that to be able to move forward? Is the expectation that you'll see something better? If you don't see something that was as good as ziritaxestat, would that be something you'd consider in terms of whether you'd want to move that forward or not. Thanks.
Okay. Thanks for this question on PINTA. We see IPF as a space of unmet medical needs, where there are early treatments approved, but where we hope to bring to patients treatments that are at least as effective, if not better, and as well can be differentiated on safety. We think that in that space, in that disease, there is space for more than one safe and efficacious drug. In the end, that's still a dream, if you could combine different mechanisms of action, that is assumed to be a good way to get more control and to slow further down the progression of that disease. In that sense, in PINTA, which is a proof of concept we hope to see and the primary endpoint is FVC.
We've also included FRI to see a clear signal that our drug is effective within the same range as ziritaxestat. We have longer data here. It's not a 12-week, but it's a 24-week study. We have a larger patient group. It should help us well to come to better data that will allow us to take the best decision in this program. Thank you.
We'll go next to Alex Cogut with Kempen .
Hi, Thanks for taking my question. I'd just like to understand a little better the timing of the three readouts this year. Maybe if you can share a bit, how would you expect the sequence of them to be and whether we should take later, meaning simply late in Q4? Thanks.
I'm sorry, I'm not sure I heard you. You were breaking up a little bit. I don't know if anybody else heard the question.
What is it about the sequence of the readouts in phase II? How is it planned? We have the NOVESA, we have the PINTA and ROCCELLA. Can you comment on how you see that sequence?
Yeah. I'm not sure if we have the details of it, but I think we should be expecting those data in the second half of the year. Probably, the first one would be NOVESA, and then I think ROCCELLA and PINTA might be right around the same time. That's kind of where we are with this.
Right. With later, you're meaning essentially Q4, right?
Yeah.
Okay. Thank you.
At this time, there are no further questions.
All right. Well, thanks, everybody. That does conclude then our call. Please just reach out to the IR team if you have any other questions. Our next scheduled financial results call will be for the Q3 results on the 6th of November. Thanks everyone again for all of your participation, and wish you all a great weekend, and please stay safe. Thank you.
This does conclude today's conference. We thank you for your participation.