Galapagos NV

NASDAQ:GLPG

Earnings Call Transcript 2018-Q1

[Operator]

Good day, and welcome to the Galapagos quarter 1 webcast and conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Elizabeth Goodwin. Please go ahead.

[Elizabeth Goodwin]

Thank you, and welcome all to our results call today. I am Elizabeth Goodwin, Investor Relations. I'll be hosting the event. This recorded webcast is accessible via the Galapagos website home page and will be available for replay later on today. So that your questions can be included, we request that you dial in to the number given in the press release from last evening, that's 32 for Belgium, 24040659 and the code is 5747918. I remind you that we will 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's actual results may differ materially from the results expressed or implied in these statements. Today's participants will be on Onno van de Stolpe, CEO; Walid Abi-Saab, CMO; Piet Wigerinck, CSO; and Bart Filius COO and CFO. We will begin with some PowerPoint slides, followed by a Q&A session. And with that, I'd like to hand over to Onno. Go ahead, Onno.

[Onno van de Stolpe, Co]

Thank you, Elizabeth. Welcome everybody to our webcast. We have decided to change the format of the webcast somewhat by making the official part of the presentation quite a bit shorter to allow more time for Q&A. So I'll jump right in with the first slide about the delivery in the first quarter of 2018. If you look at the inflammation part of our portfolio, we were very happy that filgotinib Phase II trials in psoriatic arthritis and ankylosing spondylitis were fully recruited. Very pleased that, that went ahead and on time, and we're awaiting the data when the results will come in. We also announced the target engagement in OA patients of '1972. Very pleased with the outcome of that, and that's the basis of the large Phase II study that's being planned. We also announced the MOR106 results in atopic dermatitis at the AAD conference.In IPF, we were very pleased that the FDA and the EMA agreed to our plans to move this program directly into a Phase III program, and we announced the planning of this program recently. And I'll come back to that. In cystic fibrosis, we completed our Phase I study with the second triple, and we also completed the recruitment of the PELICAN study, which is the combination of RC2 with Orkambi. And then finally, we got approval for the FALCON first triple combo trial. So we'll be moving our first triple into CF patients, and I'll lay out the trial design later. On a corporate level, we announced a cash balance of EUR 1.1 billion by the end of the quarter. So let's start with the Phase III program ISABELA for '1690, our IPF program. We will conduct 2 Phase III programs for a total of 1,500 patients, and all these patients will remain on the standard of care throughout the trial and they will stay on drugs throughout the whole Phase III program until the last patient has been dosed. There will be 2 dosages tested. It's a 52 week trial, and afterwards, it will continue in an open label extension. The primary endpoint is forced vital capacity, and there are a number of secondary endpoints in this trial. It's exciting for us. It's our first Phase III that Galapagos will be running ourselves, and it is quite something that after one Phase II trial, key opinion leaders as well as the regulatory agencies all supported the move of this program into a Phase III registration trial, very exciting for Galapagos. If we move to cystic fibrosis, the FALCON study is long awaited; it's taken a long time before we got the approval from the authorities and the ethics committee in the U.K., but everything is now in order, and we can move forward with the recruitment of these patients and the opening of the centers. We'll have a trial designed that's listed in this slide, where we start with a dual, followed by a triple dosing, both of them for 2 weeks. And we'll start with a first dose in homozygous patients, delta F508, and then followed by a second higher dose, where we'll dose both in heterozygous as well as homozygous patients. Small cohorts, short dosing, but that should be sufficient to give us a good view on the safety as well as the efficacy of the triple into patients. Primary endpoints are safety and tolerability, of course, PK, but also very important to look at the efficacy levels in this trial. If you look out for the rest of the year, then you'll see a number of late-stage trial initiations. We're nicely on track to execute everything there that we were planning to execute. And a number of those trials will take quite a long time to recruit and, of course, administer the drug, so they will run for a long time. But the good news is that we're also expecting a lot of trial results in the time to come. If you look at this quarter, we'll get the read-out of filgotinib in psoriatic arthritis. We'll get the PELICAN cystic fibrosis study. Also important, we'll get the go, no-go with regard with filgotinib in ulcerative colitis, if it will move from the Phase II into Phase III. We will not release data on that. It will just be an announcement that this trial has moved from a Phase II to a Phase III. And we're expecting very shortly the full enrollment for FINCH 1 and FINCH 3, greatly ahead of the original scheduled timing. For the next half year, to after this quarter, very importantly, the first Phase III trial will read out, the FINCH 2 trial in -- with filgotinib in RA. Also the Phase II trial of filgotinib in ankylosing spondylitis, and we'll get the first triple combo data of FALCON. So a lot to look forward to. And with that, I am happy to hand it over to our CFO. Bye.

[Bart Filius, COO & CFO]

Thanks, Onno, and good morning, everyone in the U.S., and good afternoon in Europe. Happy to give you the view on the Q1 financials as well. And as usual, I'll start off with cash, which is a slide that many of you have seen before, but then with the updated numbers, obviously, for 2018. And we closed out the quarter with a cash balance of EUR 1.1 billion, down from EUR 1.15 billion at the end of December. Our net cash burn in our definition was EUR 40 million for that quarter, consisting on one hand of cash out, cash expenses, of roughly EUR 60 million and on the other hand, cash income from milestones of a little less than EUR 20 million. So we've maintained our guidance, obviously, in the first quarter. We're early on in the year. Between EUR 220 million and EUR 240 million for the full year. So we're below that 25% mark after the first quarter. That's really due to 2 reasons, one hand is, obviously, as you can see, the offsets of cash income from milestones. And on the other hand, the expenses will be gearing up towards the later parts of the year, when the ISABELA programs will go online in full in the second half. Two other elements that have influenced our cash position to a lesser extent, a bit from capital increases. Those are related to warrant exercises. And we have a currency translation effect, which is really not cash in the sense that it's not a cash expense but it's a translation of our dollar position into euros due to the weakening of the dollar against the euro, on average, over the quarter. Then, on the next slide, I'm summarizing the key other components of our P&L. Also, as Onno was doing, in a shortened version compared to what we've done in the past. So I'll take you through the P&L on this slide with the highlights thereon. Revenues are up by EUR 5 million to EUR 45 million. That includes roughly EUR 10 million of revenue recognition that is due or thanks to the implementation of IFRS 15, a new accounting guideline that has led us to evaluate our position vis-à-vis the Gilead and the AbbVie contracts at the opening balance sheet of 2018. And we are recognizing roughly EUR 10 million in this quarter, and this will influence our top line positively for the next 8 quarters, so until, let's say, the end of 2019, is our estimation, by roughly this amount, to total roughly EUR 80 million of re-recognition on the IFRS 15. So this is all a bit complicated. It's really all accounting-driven. There's really no cash involved. This is all about when we recognize and how we recognize license income and milestones from those partnerships with Gilead and AbbVie. Our operating costs are EUR 77 million, and they are higher by roughly EUR 25 million vis-à-vis the same quarter of last year. That increase is some that we've seen over the last sets of quarters and is really driven by the mid- and late-phase pipeline and the significant number of Phase II and Phase III trials that we're actually running at Galapagos. And then finally, net results down by EUR 24 million, mainly driven by the operating costs, but also this unrealized currency translation effect has a negative on our P&L, even though we see this is not fully materialized until you expense it. So with that, I conclude the financial comments. There is clearly a lot more detail in our Q1 report available on the website, or I'm happy to take questions as well. And with this, I'll hand it, actually, back over to Elizabeth to take us through the Q&A, for which Onno and I are available, but also, Walid and Piet are available for taking any of your questions.

[Elizabeth Goodwin]

All right, thank you, very much, Onno and Bart. That does conclude the presentation part of our call today. Now I'd like to ask the operator, Claddagh, to connect us to callers with questions for the team.

[Operator]

[Operator Instructions] We will take our first question from Anastasia Karpova from Kempen.

[Anastasia Karpova, Research Analyst]

Hi, 2 clarifying questions on the upcoming read-out. Mechanistically speaking, would you expect to have dramatically different efficacy in psoriatic arthritis compared to what [ sulfa ] has shown due to lack of JAK3 inhibition? And for the second, can you help me understand how aggressive is the futility threshold in the upcoming ulcerative colitis trial? Is that something that's very challenging ahead of available therapies or something more conservative?

[Walid Abi-Saab]

Okay, this is Walid. I guess I'll take both questions. So first, let me start with the futility analysis. So the point there is to compare each dose of filgotinib to see whether it's performing worse than placebo. And if that's the case, you would meet futility. So essentially, the point is that the threshold is really not very high. So in other words, it's very unlikely that we will be meeting that futility analysis. But that's an important test that we needed to do. On your other question regarding mechanistically whether we see -- we expect anything different than tofacitinib, I would expect we should be expecting at least efficacy as good as tofacitinib, but we are hoping that we are going to be better on the account that we are not as limited by the dose that we can give because of concerns with going to sort of nonselective hitting other JAKs. So we're quite hopeful that we will have efficacy better than tofa.

[Operator]

We will now take our next question from Peter Welford from Jefferies.

[Peter James Welford, Senior Equity Analyst]

Got a couple, really, on the upcoming planned trials, and firstly on cystic fibrosis. I was wondering if you could reveal the dosing schedule that you're going to be using for the different components in the triple. Particularly, I guess, with regards to the potentiator, is it still the plan to do a loading dose on day 1 and then a lower maintenance dose? And then, should we understand, in the higher fixed-dose combination dosing that's going to be used in Part II of the trial, is that a higher dose of both potentiator and corrector I? Or is that just a different dose of the early stage corrector that's going to be used in that FDC? And then, in a similar vein, for the IPF '1690 Phase III, the ISABELA trial, I presume that one of the doses, either A or B, will be the dose that was used in the Phase IIa trial. But can you give us some insights into what the other dose that was chosen will be? And will that dose be the same in both of the Phase IIIs? Or will one Phase III perhaps investigate a lower and the other a higher dose? I guess, curious with any sort of feedback you've got on the dose selection when you had the meetings with the regulatory authorities.

[Piet Wigerinck, Chief Scientific Officer]

Okay, Piet here. I will start with the question on the FALCON design. So FALCON design is the first CF study in which we'll dose our fully owned -- or our fully homemade triple combo in CF patients. So it's a design where we start with the dual lead-in 2 weeks, and then step up to triple for the remaining 2 weeks. So indeed, in this study, on day 1 the patients will get a loading dose of potentiator and then a maintenance dose. As the trial is kept quite short in terms of dosing, it's important that we are as quickly as possible on the effective levels that we anticipate we'll have for both the dose A and the dose B. So at this moment, we will not disclose which these doses are and what components we are giving -- we are escalating. That will come in later with the data. Walid, over to you for IPM, then.

[Walid Abi-Saab]

Okay, thanks, Piet. So the ISABELA studies are identical. Identical doses will be used in both trials. The top dose will be the one that we've used in our Phase II study, but we're not disclosing at this point what is the other dose, which obviously, is a lower dose in that trial. So in terms of feedback, those -- the design of the study, including the dose selection, was discussed with both the FDA and the EMA, and there was full support for our proposal. And based on that, we confirmed the trial that we moved forward with.

[Operator]

We will now take our next question from Brian Abrahams from RBC Capital Markets.

[Brian Corey Abrahams, Senior Analyst]

A couple on IPF and then on CF. On the ISABELA studies, can you maybe talk about the decision to do both combination and monotherapy in both studies rather than testing those separately? How you think about sort of powering these studies, given you'll have patients both on and off standard of care, and whether you're stratifying for patients on the individual concurrent therapies verses not on [indiscernible] or [indiscernible]?

[Walid Abi-Saab]

Okay, so you want me to answer this, and then you'll ask the CF question, Brian?

[Brian Corey Abrahams, Senior Analyst]

Yes.

[Walid Abi-Saab]

Okay. All right, so when you look at, I mean -- so just to take a step back. IPF is really a severe disease. People, when they are diagnosed, their median survival rate is about 2 to 5 years after diagnosis, which puts this in the category of some of the bad cancers. So as such, there is -- ethically, it's very difficult to do long enough trials to demonstrate efficacy on monotherapy. We're essentially changing the standard of care for these patients. They don't have 1 year of their lives to give up to do a placebo-controlled trial. This has been an issue that's been very clear to us when we talk to the KOLs, when we talk to the Pulmonary Fibrosis Foundation, which, obviously, we work very closely with, and also when we talk to regulators. So as a result, we decided to design a study to go on top of standard of care. Now the way the standard of care is, and we mostly have that information from the U.S., where the Pulmonary Fibrosis Foundation has a good assessment of the situation, we know that about a third of the patients are on pirfenidone, about a third, roughly, are on nintedanib and a third are on neither pirfenidone or nintedanib. And that is a representative sample of the U.S. population, which is going to be forming the basis of how we are going to be doing our trials. So essentially, in our trial, we will make sure that we keep people on whatever background medicine they're on. If they're on either, they can stay on either and come into our trial. We will not be dictating any changes in their background therapy. But we make sure that we are adequately stratifying, because we don't want certain groups to be overrepresented in one dose group or the other. So we'll be watching this very carefully, and it will be stratified in the trial. In terms of powering of the study, we also discussed this extensively with KOLs and with the health authorities as well. And the consensus is that there's a certain level of change or effect that you need to see on top of either background therapy or no background therapy for this to be clinically meaningful. So anything in the 30, 40 mls over a year is very weak. Just to put it in perspective, the current treatments with nintedanib and pirfenidone usually have a reduction of about maybe 120 mls to 150 mls after a year. So essentially, there's still room to grow, but anything less than sizeable, about 80 mls per year, would be perceived as nonclinically meaningful, even though you can demonstrate it in a large enough trial, it's not clinically meaningful. And this is what we used as a guide to power our studies. So our studies are powered to detect, with 90% power, which is typical of Phase III, to detect an 80 ml difference from background of treatment. And that's kind of what we proposed, and the health authorities supported us with this.

[Brian Corey Abrahams, Senior Analyst]

That's really helpful color. And just real quick on CF, I understand you're not disclosing the specific doses in the FALCON study. But I guess I'm just sort of wondering, based on prior preclinical and clinical data, whether you would expect the doses being used in Part 1 to be the therapeutic doses? And maybe what you would see as an FAD1 [indiscernible] for that Part 1, and then perhaps how the results of the upcoming PELICAN read-out would influence your dose selection plan for 2737 in the second 2 weeks, when it gets added on.

[Piet Wigerinck, Chief Scientific Officer]

Okay, Brian I'll try to answer, because you broke up for a moment while asking your question. So the FALCON study, so Part 1, we should be at around EC80, EC90 level with the first dose. So we really should see efficacy. It's clear that the dose of 2222 is informed with what we've done up to now in patients, which is well known to all of you. And so for that Part A, in fact, the only unknown there is whether our assessment of active dose of potentiator 2451 is right. But we've chosen a dose which should clearly give us a good signal in that population. PELICAN upcoming data, in principle, we don't need those data for the FALCON study to start. It's a study where we dose 2737 on top of Orkambi. There, of course, the unknown is how big will be the impact of lumacaftor in terms of PK, interaction of 2737, as well, there, based on studied results on a [ DDI ] study with the [ revamping ]. We hope to be at around EC90 for 2737, but the big unknown will be on how accurate the [ revamping ] data will predict the exposures we will observe, then, with the 2737. So if the exposure of 2737 is high enough, we should see good efficacy, but that's an unknown, and that's what we will work out in that study.

[Operator]

We will now take our next question from Adam Walsh from Stifel.

[Adam Anderson Walsh, MD & Senior Analyst]

I guess this one's for Walid. In terms of both the tofacitinib and baricitinib Ad Coms, the FDA seemed to be focused on the doses tested in the clinical trial program, and it seemed like with an eye toward whether the sponsors had identified a minimally effective dose that avoids certain AEs. And obviously, in the case of baricitinib, the agency was focused on BTEs. So with respect to filgotinib dosing in the ongoing clinical trial program, can you just remind us of the rationale for the doses you're currently testing? And whether you're comfortable that you've selected the right dose?

[Walid Abi-Saab]

Thank you, Adam. So if you recall, in the filgotinib program, we did a dose range finding in Phase II. And based on these data, the doses of 100 and 200 milligrams were selected. Those doses were reviewed and discussed with the agency at the time as part of the end of Phase II meeting. And they were approved and endorsed. What came clear in the Ad Com is that the FDA wants to see a robust database to allow adequate decision making for each of the doses. And I'm very pleased that this is exactly the plan that we and Gilead have put together not only for RA, but also for the IBP program, where we test fully 100 and 200 and not favor one versus the other, such that, at the end of the day, we will have a solid database that will permit us to make the adequate risk/benefit assessment of each dose and be able to recommend whether one, the other or both should be recommended for approval.

[Adam Anderson Walsh, MD & Senior Analyst]

Okay, that's helpful. And then just one follow-up if I could. On the ISABELA Phase III program in IPF, can you just give us a rough idea when we might see first data from those trials?

[Walid Abi-Saab]

It's a tough question, Brian. At this point, I don't feel comfortable guiding on the time. And for the simple reason is that there's no good way to estimate it. So now when we do our feasibility and talk to a number of people, they come back with some numbers based on their experience with pirfenidone and nintedanib in the past. But we're dealing with a completely different situation right now. One, there is a vastly different appreciation of the disease that we have today compared to when both these studies with pirfenidone were conducted, the Phase III programs. And number two, in our case, we are going on top of standard of care, whether you are on nintedanib or pirfenidone or you are not. And as such, we believe that our inclusion/exclusion criteria are also vastly different. And I think we're not getting accurate, actually, results. And I don't feel like we should be guiding at this point before we start seeing and realize how well we're doing with recruitment. And we will be able to come back with better estimates at a later date.

[Operator]

We will now take our next question from Vamil Divan from Credit Suisse.

[Vamil Kishore Divan, Senior Analyst]

So just 2 things. One on the filgotinib side, and then one on CF. So on filgotinib, if you could just provide an update on the long-term safety study and timing around when those results will be available. And just to confirm, because we've gotten some questions, if that is a requirement before you can submit the filing to the FDA or not? If you could confirm that. And then on -- going back to CF and the FALCON study, just with 2451, I'm just curious, if there is any special sort of safety requirements incorporated into that trial, given some of the previous discussion around the longer lasting metabolites? Is there anything beyond what you normally would be doing in a trial of this sort?

[Walid Abi-Saab]

So may I ask a clarifying question. This is Walid. You said long term safety?

[Vamil Kishore Divan, Senior Analyst]

The male safety trial.

[Walid Abi-Saab]

The male safety trial, right. So the male safety trial is ongoing, as we talked about -- as we discussed previously, and we believe that we will have the right data set by the time we are ready to file, to be able to have a total package that would satisfy the FDA's requirement.

[Piet Wigerinck, Chief Scientific Officer]

Okay, Walid. Thanks, I'll comment then on the CF question. Well, in this, which is in the FALCON study, which is the first time we dose 2451, in Phase II. It's logic that we want to follow-up both safety and efficacy of 2451. Also there is a component allowance. What is foreseen in the protocol is that the patients will be invited to come to the center as long as we detect the long-living metabolite. And so the expectation is that with a couple of months, that will disappear, but that's what is foreseen currently, that we monitor the metabolite up to the moment where it disappears.

[Operator]

We will now take our next question from Phil Nadeau from Cowen and Company.

[Philip M. Nadeau, Managing Director and Senior Research Analyst]

Just a couple on the design of the FALCON study. I was curious about a couple of things. First was on the 2-week lead-in with the dual therapy, what's the rationale behind that? Is that to show the additive efficacy of the C2? Or is that to get the dual therapies up to steady state levels before adding the C2? That's the first question, and the second question is in Part A, why are you looking at only homozygous patients? Why not include heterozygous patients, het/min patients in Part A as well? Or Part 1, sorry.

[Piet Wigerinck, Chief Scientific Officer]

Okay, thank you for the question on FALCON. So the 2-week lead-in dual and then 2-week triple, indeed, the reason for that is that we really want to see what the additional benefit is of the C2 to dual therapy. If you would start with a triple therapy immediately, then whatever you can mention in terms of improvement at the end is a sum of the 3, and you -- it's impossible then to distinguish how much comes from the C2 and how much comes from the dual platform. So that is -- that is the reason why we've chosen 2 weeks dual lead-in, and then add the third component so that we have a comparison as well, dual versus triple, and what -- how good a dual platform is and how much the C2 adds to it. The homozygous, heterozygous, that more has to do then as a consequence of the dual lead-in where, in fact, for the heterozygous, you don't expect too much of efficacy. So that's why we said okay, putting the heterozygous patients on the 2 week lead-in is something which, okay, there is zero benefit from them expected. And that's why we have limited that to one part of the study only, is the reason.

[Philip M. Nadeau, Managing Director and Senior Research Analyst]

And then one last follow up question on CF. On the PELICAN trial, I think in the answer to a previous question, you said if the levels of 2737 that are achieved are sufficient, you expect to see good data. I'm just curious, in your mind, what would be a good additive impact on FEV1 on top of Orkambi?

[Piet Wigerinck, Chief Scientific Officer]

So I think in the previous call, I said something around 5% of additional FEV, and that's the threshold that we hope to achieve that. So let's stay with that number.

[Operator]

We'll now take our next question from Christopher Marai from Nomura.

[Christopher N. Marai, Managing Director and Senior Analyst]

On just, first, on FINCH 2, with top line data expected sort of midyear, I was wondering if you could comment if you would be releasing any data beyond the primary -- or beyond the ACR20? Any ACR50, 70 at 12 weeks? And then, perhaps, could you comment on any of the safety that you've seen in the ongoing trials of filgotinib? Maybe talk about any DVT or any other signals that may have popped up.

[Walid Abi-Saab]

Okay, I'll get this one, it's for me. It's Walid. Thanks, Chris, for the question. So with regard to the top line for FINCH 2, this is something that we have to discuss with our partner. Right now, we don't have a clear visibility exactly today that we can share with you about what we will be sharing. We have to keep in mind also certain conditions about -- that would later not be detrimental to us being -- publishing these data and showing them at major conferences. But there are, obviously, some important information that we will have to share, because they are important for our company from a material perspective. Turning to your other question on the safety. Of course, with -- this is a heightened issue in people's mind after the Ad Com also recently. So we will be presenting data from our ongoing open-label study DARWIN 3 at [indiscernible]. So that would be week 108, so approximately more than 2 years, actually, at this point, open-label data. So I don't want to steal the thunder from that, but we're quite comfortable with the data that is coming to date. And we'll be sharing this. But I think our DVT and atherothrombotic events rate is still in the low level of around 0.1 event per hundred patient-year, which we're actually quite pleased with so far.

[Christopher N. Marai, Managing Director and Senior Analyst]

Okay, great, and then just maybe one more on ISABELA. Could you maybe comment on the recruitment across geographies for that trial? And the expectation for standard of care use across geographies? And then maybe comment on any interim analysis that you may be doing, futility analysis, when those might occur. And if you're doing a sample size readjustment at any time point in that trial.

[Walid Abi-Saab]

So geographies, we're going to be going global, U.S., big EU and also Australia. Around the world, honestly. But we have to be very careful with the patients that we get in. We have to make sure that the composition of our patients would reflect standard of care that we see in the U.S. and the big EU 5. And that's important because if we are going on top of standard of care, we need to make sure that the standard of care that these patients are receiving are similar to a standard of care for the U.S. and the European countries so that we can be able to extrapolate through that patient group. With regard to a futility analysis, yes, indeed, I think it's important for us. As much as we are confident in our data from the FLORA study, it still is a smaller study of a shorter duration. And now we're taking a big leap into a robust Phase III program, 1,500 patients total for an at least one-year duration in this program. So it's important for us to include a futility analysis in the event that we're making the wrong call and the data from FLORA are actually -- were a fluke, so to speak. So we will be conducting this. We haven't yet precisely nailed the number of patients we need to have before we do it. But currently, our thinking is when we have about a quarter of the patients enrolled and gone through 1 year of treatment, we will do a futility analysis, which will allow us to decide whether we should stop, if we have futility across both doses, or continue with the trial if at least one dose is not futile. That's the current plan. We do not have any plans to do sample size reestimation based on variability. We've used the totality of the data from the -- we were fortunate that there's a large database in nintedanib and pirfenidone to give you a sense, from their placebo arm but also from the treatment arm, about the magnitude of the variability and the standard deviation. And we've used that pooled standard deviation, specifically, it's 270 mls, if you guys are interested, to be able to draw our sample size based on that.

[Operator]

We will now take our next question from Matthew Harrison from Morgan Stanley.

[Vikram Purohit, Research Associate]

This is Vikram on for Matthew. So we had a question on MOR106, could you just update us on the subcu formulation work you're doing? And if you could let us know if the study that's being conducted later in 2018, is that going to be using the subcu formulation or not?

[Piet Wigerinck, Chief Scientific Officer]

Okay, Piet here, I'll take the question on MOR106. So MOR106, we've planned a couple of studies this year. So the first study that we'll kick off, and where we hope over the coming weeks to have first patient in. At that moment, we will know as well the design. It's a dose range Phase II study where we have 5 dosages and placebo. This will be an IV study, and so in parallel to this Phase II study, we will start first into humans with the subcu as well this year. And so the idea is that, that subcu study will both run as a single dose in healthy volunteers, but as well a multiple dose in patients. And then the idea is to bridge the subcu data from the patients with the IV data for those ranges to select a subcu dosage for further development. And so we'll be running both subcu and IV studies this year. That's the short answer.

[Operator]

[Operator Instructions] We will now take our next question from Katherine Xu from William Blair.

[Katherine Xu, Co]

I'm just wondering, with regards to the cystic fibrosis program, can you provide some color on why the delay in the U.K on the start of the triple FALCON study? And then, does that impact the strategy on the rest 2 triples? Are they on track? And then if you could provide time lines for those, that would be helpful.

[Piet Wigerinck, Chief Scientific Officer]

So the questions were a bit difficult to understand, so I'm assuming the first question was on the approval time for the FALCON study. So...

[Katherine Xu, Co]

Yes.

[Piet Wigerinck, Chief Scientific Officer]

Yes. So over recent years, I think we've shown that, typically, we are quite reasonably good in our estimates of starting of the time line. FALCON falls a bit outside those estimations. So the dual effect, no, I can't point to a specific reason. We've been in contact with the principal investigator in the U.K. He's been to the ethical committee as well, and we, in fact, if you see what type of questions we did receive, they were more standard questions that we could answer quickly. But for one or another reason, we don't know why, the formal procedure to get a signed approval took a bit longer than we normally had. And then you were questioning on time lines for the other triples. So the PELICAN study, that is on track. So we will report after Q2. Then we plan, as well, to start up another triple study with [ 3057 ] as the potentiator. So this will be a bigger study with dose ranging components of both 3067 and 2737. So we are on plan there. So we've announced that we've completed the Phase I package for the triple both as [indiscernible] in the healthy volunteers, and we've been discussing those data with the authorities, and we'll file soon the [indiscernible] application, as was done previously, so and those dates are what we have been given before.

[Operator]

Thank you, it appears there are no further questions, so I'd like to hand back the call to the speakers for any additional or closing remarks.

[Elizabeth Goodwin]

Thank you all for your participation today. I just want you to note that our next planned financial results webcast is on August 3, with publication of results the night before. So please mark that on your calendars. Thanks again to all the callers for the support and participation, and thank you and good-bye.