Aug 7, 2020
Operator
Good day, and welcome to the Galapagos Half Year Results Call. At this time, I'd like to turn the conference over to Ms.
Elizabeth Goodwin. Please go ahead.
Elizabeth Goodwin
Thank you all for joining us today for the audio webcast of Galapagos' 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 into one of the telephone numbers given in last night's press release.
I've got one for you here, 32 for Belgium, 2404-0659, with code 8997710. I'd like to remind everyone that we'll be making forward-looking statements during today's webcast.
These forward-looking statements include remarks concerning future developments of the pipeline and our company and possible changes in the industry and competitive environment. Because these forward-looking statements involve risks and uncertainties, Galapagos' actual results may differ materially from the results expressed or implied in these statements.
Today's speakers will be Onno van de Stolpe, the CEO, as Bart Filius is away. Onno is 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 and we estimate that this will take about 10 minutes. And 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 is our Chief Commercial Officer.
And now I'd like to hand to Onno. Go ahead Onno.
Onno van de Stolpe
Thank you, Elizabeth, and thank you all for attending this webcast. I hope you all are enjoying the summer, weird summer in view of COVID-19, but we are 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 that's caused 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.
This 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 [indiscernible] and monitor the all in combination with methotrexate, which was expected in the recommendation, so we're very pleased with that recommendation.
All of this is based on the FINCH and the DARWIN data, the Phase 3 and the Phase 2 dataset that in total included 4,500 patients experience. So there is a lot of efficacy and safety data on filgotinib with the regulators.
So, we are now awaiting the EU marketing authorization that normally should come in two months period. So if we look at how we are approaching this in the commercialization, then clearly we go start in limited number of countries.
Gilead will have the remainder of Europe to introduce filgotinib in RA, with Galapagos will do this in the Netherlands and Belgium, as well in France, Italy and Spain, so quite a large geography where Galapagos is responsible for the full marketing and commercialization of filgotinib. And we are 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 UK and Germany, so different geography, yes and for rheumatoid arthritis.
Big advantage for us is that we can gradually increase our marketing efforts and footage in Europe preparing for full European presence on the commercial side for our next product that would hit the market and most likely that should be our products for, yes idiopathic pulmonary fibrosis, ziritaxestat. So for now, we are ramping up for the first quarter [ph] launch for filgotinib in those five territories which we believe is a great challenge with very low, ready to can take on that challenge and we're very well prepared.
So with that, we'll go to the next slide, let's then take couple of minutes on the SELECTION Phase 3 results in ulcerative colitis with filgotinib. Clearly we saw very good data coming out of this trial.
We hit the primary endpoint, both with the 100 mg and the 200 mg on EVS [ph] remission at week-10 and 68, 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 and 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 what we have seen with other trials in rheumatoid arthritis and other indications.
So the full data will be presented at a future medical conference in collaboration with Gilead obviously. So 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.
So we've started the year at €5.8 billion and the big cash burn this year on the operational side reduced at €230 million completely according to plan, so we ended the first half on a cash file of €5.6 billion. So that was completely in line with expectations.
If we can go to the next slide, you'll see the financial highlights. And we see the revenues going up substantially compared to a year ago, we had an extra €160 million which landed the revenues at €224 million.
Having said that, 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 received through the option agreement and the upfront that they have paid and that is recognized over a 10-year period, so that brought us to the total revenue of €224 million. Operating costs went up substantial with €150 million and that's we are expanding in all areas be it development, research, G&A and also of course the preparation of commercial loans will start to kick in seriously on the financial side.
So all according to plan and we're very pleased with how that is all coming along. Total debt combined to the net results of a loss of €165 million compared to a loss of €70 million last year and that of course is a consequence of the substantial increase that we're doing in the various aspects of our business and nothing to be concerned about and actually had previously communicated to the market that we would ramp up pretty much all the expenses in research, development and commercialization.
If we go to the next slide, we have provided our guidance for operational cash burn of €400 mg to €430 million and that includes $205 million in potential milestones subject to regulatory approval. So those milestones have to come in to enable us to keep that cash burn if the milestones for whatever reason would not come in in this year then clearly we would have a higher cash burn than the €400 million to €430.
And the last slide is about the milestones that you can expect sort of remainder of the year. We the SELECTION data come in and we're now awaiting three Phase 2 readouts, two Phase 2a and one Phase 2b.
The first PINTA study is in idiopathic pulmonary fibrosis with 1205 and that data we are expecting shortly. Then we have the second indication for 1690, ziritaxestat and the first indication as you know was in IPF with the second indication in systemic sclerosis.
So we are getting that data in the NOVESA trial also in the upcoming month. And then also the longer wait at an important trial of 1972 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 and also that data set should come in the remainder of the year.
And then everybody is awaiting the anticipated regulatory decisions in RA, beginning in the EU following the CHMP opinion as well as the FDA and Japan, all three of them should come in, in the coming months and we should know how we're going to market filgotinib based on those decisions. So with that as an introduction, I'll hand it back to Elizabeth to take the Q&A.
Elizabeth Goodwin
Okay, thanks Onno. That does conclude the presentation part.
Questions will now be taken on a first come, first serve basis. You know we don’t manage the queue, so please limit yourselves to one question per caller today and now I'd like to ask the operator, Jennifer to connect us to anyone with questions for the team.
Go ahead.
Operator
[Operator Instructions] And we'll go first to Rashid Ali [ph] with Bernstein.
Unidentified Analyst
Hi Rashid Ali, good afternoon. Thanks for taking my question.
Do you expect a warning on the filled out label for tested kind of toxicity and if there is such a warning, how could filgotinib and the label post MANTA data and what impacts could you see on uptake as a result of that? Thank you.
Walid Abi-Saab
Maybe I'll address the regulatory question and then turn it over to Michele. This is Walid.
Good morning, good afternoon to those folks on the phone. The – I am assuming you are referring to the European label, because we don’t know anything about the U.S.
yet. So I think the MANTA data is or MANTA studies are meant to evaluate whether we see any evidence of effects in humans based on the safety or as per toxicity these endpoints that were used and those data will be very important to inform actually on any potential risks to humans.
And so, 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. And we believe that those are the right – 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.
And I'll turn it over to Michele regarding the uptake question.
Michele Manto
Yes, so based on what Walid said so the driving force will be the label, so of course we have confidence, but there is no point to speak with now and again we also know that the rest of the profile of the drug becomes [indiscernible] to make us make a good note.
Unidentified Analyst
Got it, thank you very much.
Operator
We'll go next to Debjit Chattopadhyay with H.C. Wainwright.
Debjit Chattopadhyay
Hey, good afternoon. In the SELECTION study, male patients on the 200 mg dose had both a TNF and etrolizumab [ph] which lowered the placebo adjusted rates to between 8% and 11% range, well short of clarity on how women might have fared if those and if these rates are comparable?
Thank you.
Walid Abi-Saab
Yes, thank you for the question. You broke up a little bit, but I assume you are asking whether there is any different between males and females and the trial and I'll be honest, we haven’t yet disclosed those information, so 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 with etrolizumab [ph], TNF, both failures on both and how do they compared 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 at the – when we present the data at an upcoming conference. It is suffice it to say that in this trial we had, and I think Onno alluded to that, we had as you can imagine higher number of people who have been exposed to two different types of biologics, TNF and [indiscernible] and we have a significant number of patients, close to about 50% who actually got exposed to both and not just one or the other.
And so we are looking forward to share those data with you at an upcoming scientific conference.
Debjit Chattopadhyay
Thanks.
Onno van de Stolpe
Thank you.
Operator
We'll go next to Evan Seigerman with Credit Suisse.
Evan Seigerman
Hi guys, thank you so much for taking the question and congrats on the progress. So as we head into the potential launch of filgotinib in the United States and Europe, can you just kind of review some of the pre-commercial activities you're engaging with especially in Europe, given how competitive the space is?
Any point of differentiation? I know it's a common question you get a lot, but it is a question I get a lot as well.
Thank you so much.
Michele Manto
Yes, hi this is Michele. Thank you for the call.
So, first things, we got up and this of course was to build up our present operations as Onno highlighted in the slides earlier, and very happy with the progress we're doing with that. So, first thing of course being the recruitment of the team.
So we are recruiting really strong talent probably with experience in Array [ph] and respectively in IBP already in Germany and UK, who really have already strong contacts there with the customers, know the market, and at the same time also experts in Medical and Access. And as you can imagine now the first actions are of course talking and planning the best and most effective way to achieve reimbursement, and also setting up the contacts in a compliant way, that we can have before the actual approval of filgotinib.
And despite also the COVID situation and strong contacts, strong first adverse [ph] connections with the expert, very strong also feedback, and expectation about our upcoming launch. And as you know, also I have observed the very strong presence of [indiscernible] in virtual way, was also way to test our mutual capabilities given the uncertainty on the future scenario, we got together with Gilead, and our presence there our dealer was top level with the top leaders in rheumatology.
Thanks for the call.
Evan Seigerman
Great, thank you so much.
Operator
We will go next to Brian Abrahams with RBC Capital Markets.
Brian Abrahams
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 divisions 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 male patients that were enrolled in the U.S.
at that dose? Thanks.
Onno van de Stolpe
Yes, thanks, Brian for this question. Yes, tough to answer.
All 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 agency sits on this.
It just would be speculation at this point. So, I think it is suffices 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.
But I cannot speculate on where the agency would sit and about approval on the 200 milligram, so we're going to have to wait a bit longer for that.
Brian Abrahams
Thanks. Okay, understood.
Thanks.
Operator
We'll go next to Jason Gerberry with Bank of America.
Jason Gerberry
Hi, good morning. Thanks for taking my questions.
So my question is just on filgotinib, when you, 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. I just wanted to confirm that you will be conducting trials in other populations or is that going to be strictly limited to the EC [ph] population?
Thanks.
Piet Wigerinck
Jason, Piet here. Thanks for the question on the other pipeline.
Note for the later program we remain as ambitious as we've been before and so filgotinib [ph] is going to be explored broadly. We'll start with different, I will have different ways to start with, we have one which will have three proxies, and that will come to wave 2 which has longer studies and then wave 3 which is under more chronic indications, but we remain with our ambitions.
And we plan to start in the second half if COVID allows a different number of clinical studies there. Thank you.
Jason Gerberry
Thank you.
Operator
We'll go next to Matthew Harrison with Morgan Stanley.
Unidentified Analyst
Hi all. Thanks for taking the question.
This is Connor on for Matthew. So just two quick ones for you.
Can you comment on the enrollment speed in the IPF studies, and if they remain generally on track mid COVID and on track with the futility [ph] analysis? And you noted in your press release pending successful start of the Toledo studies, do you plan on providing more information?
And so, we're just wondering if you could provide more information on what kinds of impacts you're seeing and the potential for delay on those given COVID? Thank you.
Walid Abi-Saab
All right, so I'll take the first question. This is Walid.
I'll talk about the developed program. As we've discussed before, in a developed program, just like virtually everybody, the COVID had an impact on these trials and enrollments.
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 in the recruitments, 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 in the first half of next year. So, while the situation is fluid as you know, we continue to with that caveat in place, currently we feel optimistic that we are starting to see a pick up, maybe less so in certain parts of the U.S.
and mostly in Latin America, but the rest of the world I think we're seeing a return gradually towards normal, not fully there yet, but on our way.
Onno van de Stolpe
Thanks Walid. I will go for the question on the COVID impact on the Toledo study, so 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 planned to start up the studies, we simply could not get them to the hospitals, and they were not ready to initiate any clinical study.
So that's now over and our current view is that we will be able and that is out of our direct context with [indiscernible] science that we'll be able to starting of these studies in the second half of the year, so 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.
And so, we are we are confident today that we will start up those studies in the second half. Thank you.
Unidentified Analyst
Thank you.
Operator
We'll go next to James Gordon with JP Morgan.
James Gordon
Hello, thanks for taking the question, James Gordon with JP Morgan. My question is actually on OpEx, so OpEx was about $200 million when you quoted last night annualized and about $100 million and if you look at the 2021, so could you make out ramp up in sales and marketing and also what's going on in the pipeline.
So, the next could OpEx significantly exceed this higher annualized 2020 figure or is this somewhat exceptional for this quarter?
Onno van de Stolpe
Oh, we haven't given guidance yet on 2021 clearly. This is Onno, thanks for the question.
But it's clear that our costs are going to increase in regards to the ramp up of commercial, especially as we are ramping up so already. Of course, also our trials continue to mature to a later stage, so we'll be doing more Phase 2s and also more Phase 3s, so the costs are going up.
On the other hand, we will see our first commercial sales coming in, so we see revenues coming in. We have shorter milestones coming in with regulatory approvals.
So it's pluses and minuses, but in general it is clear that 2021 is not going to be financially a year where we will be moving closer to, to a breakeven or profit situation.
James Gordon
Thank you.
Operator
We'll go next to Lenny Van Steenhuyse with KBC Securities.
Lenny Van Steenhuyse
Hi, good afternoon, everyone. A question on the commercial side from my end, who has seen [indiscernible] being able to ramp up or invoke 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. So I was wondering, how do you think about differences and 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 was possible versus Europe or U.S., can you give a bit of color on that?
Michele Manto
Yes, thank you for the question. This is Michele.
So of course it's also a very unique time to look at our pickers with COVID pandemic ongoing, that of course affects the number of patients being treated being started. That's it.
Of course we’re looking a bit and looking at the geographies, our focus is on Europe specifically and plus with the strength of Gilead to do a great launch in the U.S. and prepare for it.
The difference of course if can look at is how, for example, [indiscernible] launch also in Europe and we stay in there, also strong uptake we have already 15% plus from those two products and becoming JAK the next mode of action after anti-TNF. In the U.S., very successful deal, but if you want specifies the mutual patients for new oral therapies that are there.
And so that's was also base for new JAK, JAK launches and that’s very important and that's very important as well. The other element that also very reassuring for the need of JAKs is the fact that all across the geographies JAKs are being used, also in first lines on naive patients, whereas in the major years that was only to limit the use in TNF failures and that also creates another need, another action for successful launches.
Thank you for the question.
Lenny Van Steenhuyse
Thanks very much.
Operator
We’ll go next to Emily Field with Barclays.
Emily Field
Hi, I just had a quick follow up on the question on OpEx. I couldn't quite hear the comment, the last comment you made on 2021.
Did you say that, that will be progressing towards breakeven, just if you could clarify what you said? And then my second question was, I believe this would be for Walid, a competitor recently showed very compelling data in psoriasis with a IL-17 A 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 particularly compelling mechanism of action in those two indications? Thank you.
Onno van de Stolpe
Okay, I'll give Walid a second to think, I'll start. Yes, ma'am.
What I said maybe wasn't clear to hear is that because of the substantial increase in costs next year related to commercial as well as to our pipeline progression, we're not expecting that we will be moving towards breakeven. So you can assume that our cash burn will at least be as high as efficient.
So yes, Walid?
Walid Abi-Saab
Yes. Thanks, Emily.
Look, I think, the data that we have currently with the JAKs based on the way we know that the mechanism of action is in RA and also our initial data in psoriatic arthritis, including also our competitors tell us that we have very good efficacy there. Whether or not the competitor will have similar efficacy and less efficacy is slower onset of action, those are things that will remain to be seen, when we have those data, I mean, 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 effects. And 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.
And also, we've seen some data also with other JAKs that show very good effects of psoriatic arthritis. So we're very confident that we'll be very competitive in that space.
Thank you.
Emily Field
Great, thank you.
Operator
We’ll go next to Benoit Louage with Degroof Petercam.
Benoit Louage
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 end the submission for filgotinib in UC, that would still be planned for this semester or would it be more in 2021? Thank you.
Onno van de Stolpe
So, usually submission for another indication will need to wait for approval and the first indication, so this would be then dependent on for the U.S., what's happening with the RA. And for Europe, I think now the path seems to be clear, usually we should expect an opinion from EU that follows the CHMP advice, but again, there's always they have their prerogative to change their mind.
But assuming that they were going to go down that same path, we would expect that to still happen this year. And similar for Japan, we still are on track, but first we need to hear on the primary indication before we move forward.
Benoit Louage
Thank you.
Onno van de Stolpe
Thanks.
Operator
We’ll go next to Dane Leone with Raymond James.
Dane Leone
Hi, thank you for taking the questions and congratulations on the progress. I just wanted to actually to focus on IPF.
Could you just kind of one set the table for us a bit with PINTA and what you're expecting on that feed out? And any color on your thoughts around what we had seen historically with Palmitic acid [ph] with similar mechanism?
And then, secondly, we get asked the question on the stat plan for ISABELA a lot around the futility analysis. Could you just update us, just remind us of the particulars of the stat plan for that futility analysis?
Thank you.
Walid Abi-Saab
So Dane let me start with the ISABELA stats and then we'll see who will take the PINTA question. So, the plan for the futility is, as you 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.
And this is was 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 are, who have completed 52 weeks plus all the others until that point, we have our various degree of involvement there. And with that, we will estimate the difference between drug and placebo on the – we see annual rate, so zero to 52 weeks.
And 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. So, it's meant to really protect us against exposing a lot of patients to an ineffective drug and that's kind of what's driving the futility analysis.
And I will ask also, maybe Piet, you want to, do you want to tackle the PINTA question or do you want me to do that?
Piet Wigerinck
Quite, I can do PINTA, but okay, PINTA is well we are pleased that the patient will be recruited. We are awaiting the results.
So it's a bit of a different design compared to FLORA in the sense that we have a mix of backgrounds there. So we have the patients on [indiscernible] about one third, one third on [indiscernible] and about one third on local standard of care which is different from one of those two because they are not available.
So in that sense, PINTA has a design which is similar to the ISABELA, but its Phase 2 proximity, so much, much more. It's a 24-week study.
So in that sense we are, we hope that second half, we can come up with a positive study, which will allow us to immediately start on top of each. We will get to 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 pleased about to progress into the next phase of studies. As we hoped for there's been a competitor which did not show well, which shows efficacy in one of the backgrounds on [indiscernible], but that did not show efficacy on [indiscernible].
We don’t anticipate to see such results, but you cannot exclude any of those. Thank you.
Dane Leone
Okay, was there something specific about the mechanism of the palmitic acid [ph] that you think your team has engineered differently? Sorry, that was the last one.
Onno van de Stolpe
Well, if you look to the two compounds, obviously GPR84 antagonist, they explained the compound is a jewel, it's hard to compare the compound, so while ours a classic, fairly potent, selective, small molecule, their compound is weakly potent and touching a couple of targets. We've instead never been able in our experiments to confirm GPR84 antagonistic activity.
So I'm not going to say that it doesn't work like that, but it is a complete different type of how it modulates a target, that is clear. And so we are hopeful and confident that in PINTA we will show that the GPR84 antagonist can show a good activity in IBS patients.
Thank you.
Dane Leone
Great, thank you.
Operator
We’ll go next to Phil Nadeau with Cowen & Company.
Phil Nadeau
Good morning. Thanks for taking my questions.
A question on 1972 clinical trials.gov lists the study has completed as of mid July. So should that imply to us that we're going to see data over the next several weeks to months?
And secondly, can you talk a little bit about the primary endpoint in the study, how is the study powered on its endpoint of cartilage thickness at this cMTFC? And what's the clinically meaningful difference on that endpoint?
Thank you.
Walid Abi-Saab
Thanks Phil. This is Walid.
So indeed the study is finished and we are in the process of doing the data cleaning and locking the database and all, with all the difficulties that we new face because of COVID-19, as you can imagine, visiting the sites and doing closing of queries and stuff like that are a bit more challenging than usual. But we're still on track to have the data in the second half of the year for the study.
In terms of the, how the study was powered and the primary endpoint. So this is - the study is powered using MRI.
As a primary endpoint, the MRI would measure cartilage thickness and the medial portion of the knee. We follow a very rigorous algorithm that is automated.
We work with the sort of the best imaging groups out there. And we've learned a lot also from a lot of studies that were conducted in the field, particularly with Furman [ph] where they had 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, so essentially, people who have a certain degree of knee osteoarthritis use, on average, about 100 micron over a year and you can measure that very accurately, actually with MRI and with the variability that we expect, we powered the studies 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. Hope, because 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. So we look forward to get the data and see how these will match or aligned with some of the very important endpoints that we measure, including pain, including function, and we will work with our experts to be able to interpret this and also we will work with health authorities to figure out how we can design the subsequent trials 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. But we are working with the right people externally and also the regulators to better understand what that means.
Phil Nadeau
That's very helpful. Thank you.
Operator
We’ll go next to Laura Sutcliffe with UBS.
Laura Sutcliffe
Hello, thank you. And on MANTA, and MANTA-RAy, you've mentioned your plans today and previously to share the data from those trials with regulators, but will you ever make the data from those trials public?
Thank you.
Onno van de Stolpe
Yes, 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. And I think the scientific community also would be very interested in it.
I am not going to go out and commit before getting that okay from Gilead, but I do, 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. And I think that's probably what we'll do, but I don't have a fully confirmed answer and ultimately this is their decision.
So I'm going to not go beyond this and promising that we will share the data. Thank you.
Operator
We’ll go next to Graig Suvannavejh with Goldman Sachs.
Graig Suvannavejh
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 2a results for that asset and 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 or could you, is the expectation that you'll see something better?
And 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.
Onno van de Stolpe
Okay, thanks for this question on PINTA. So, we see IPF as a space of unmet medical needs, where there are early treatments approved, but there are patients 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.
So we think that in that space, that is in the disease space for more than one safe and efficacious drug in the end, so 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 down the progression of that disease.
So in that sense in PINTA, which is a proof-of-concept we hope to see and the primary endpoint is what we see. We've also included MRI [ph] to see a clear signal that our drug is effective within the same range as we see in ziritaxestat, we have longer data here something is a 24-week study, we have a larger patient group, so it help as well, to come to better data that will allow us to take the best decision in this program.
Thank you.
Operator
We’ll go next to Alex Cogut with [indiscernible].
Unidentified Analyst
Hi, thanks for taking my questions. I'd just like to understand a little better the timing of the speed out is here.
Maybe if you can share a bit, how would you expect the sequence of them to be and whether we should take clearer meaning simply late in Q4? Thanks.
Walid Abi-Saab
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.
Onno van de Stolpe
Walid, it is about the sequence of the readouts in Phase 2. How we plan that so the NOVESA, we have the PINTA and the ROCCELLA, can you comment on how you see that sequence?
Walid Abi-Saab
Yes, I think, 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.
Unidentified Analyst
Right and with later you, your meaning essentially Q4 right?
Walid Abi-Saab
Yes.
Unidentified Analyst
Okay, thank you.
Operator
And at this time there are no further questions.
Elizabeth Goodwin
All right, well thanks everybody. That does conclude then our call.
Please reach out to the IR team if you have any other questions. Our next schedule financial results call will be for the Q3 results on 6th of November.
So thanks everyone again and 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.