Galapagos NV (GLPG) 2018 Q2 法說會逐字稿

Ladies and gentlemen, good day, and welcome to the Galapagos results webcast. At this time, I would like to turn the conference over to Elizabeth Goodwin. Please go ahead, ma'am.

Thank you, and welcome all to the audio webcast of Galapagos first year -- First Half 2018 Results. I'm Elizabeth, Investor Relations and I'll be hosting today's 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 call in to the telephone number given in the press release from last night. I'll give you the Belgian number, that's 32 for Belgium, 24040659 and our code is 1122269.

I would like to remind everyone 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' actual results may differ materially from the results expressed or implied in these statements.

So today's participants will include: Onno van de Stolpe, our CEO; and Bart Filius, COO and CFO, who will go through some prepared remarks. And then they will be joined by: Walid Abi-Saab, our CMO and Piet Wigerinck, our CSO for the Q&A session.

So at this point, I'd like to hand over to Onno to start the talk of the prepared remarks.

Thank you, Elizabeth, and thank you for joining us in this webcast around the first half results 2018. At first have a look at the deliveries in the first half and specifically around the developments, results that we have achieved. In inflammation, we saw very nice results in psoriatic arthritis with filgotinib in the EQUATOR trial. We also were very pleased that in the selection trial in ulcerative colitis, filgotinib moved from a Phase II into Phase III trial there. This is done in collaboration, of course, all with our friends from Gilead. Then in osteoarthritis, we started ROCCELLA, which is the Phase II trial with '1972 in collaboration with our friends from Servier. And with our friends of MorphoSys, we started our Phase II in atopic dermatitis in the IGUANA trial.

So a lot of activities there. In IPF, our proprietary programs, we started ISABELA 1 and 2, which was our first proprietary Phase III program that we are running for '1690. Everything is okay there and the first patients will be dosed in the next quarter -- or this quarter. And the PINTA trial, which is another mechanism of action, '1205 that is moving to Phase II in idiopathic fibrosis.

So lots of activities there. In CF, we shared the results of the PELICAN study, the '2737 program. We started our first triple combo trial, so 3 individual components together in the FALCON trial and that is now fully screened and we're moving forward with that data set. And then, unfortunately, AbbVie decided not to advance our second triple combo. We were planning to start that last month and you've seen that in the press release that, that was halted. So as a result, we are reviewing the status of that collaboration with AbbVie.

All in all, fantastic results here in the development front. Of course, also a lot of activities in research that we'll highlight at the future R&D Day, and all of that with a substantial cash balance of EUR 1.1 billion by half year.

So briefly showing you the results again of the psoriatic arthritis trial with filgotinib because these data were quite spectacular. We reached the ACR scores similar to what we have seen in rheumatoid arthritis, with an ACR20 of 80% and an ACR50 of almost 48%. And clearly these are the best Phase II data ever reported for any potential drug in psoriatic arthritis. So we and our partner Gilead were extremely pleased to share these results with you. Clearly, everything is being prepared to make the decision to move that into a Phase III trial.

So lots of Phase II and Phase III trials are being planned or are on the way. This is a portfolio that Galapagos has never seen and shows the maturation of the company moving into a full-fledged development organization. The ISABELA program is our biggest program as Galapagos, where we are running 2 identical Phase III programs with 1,500 patients in total in idiopathic pulmonary fibrosis. A large program, it is going to take quite a long time to recruit and to run for 52 weeks but a lot of excitement in the community around this program as well as on the trial design. With MOR106, we have started the IGUANA trial, also a large trial for 12 weeks of shorter duration. Then in osteoarthritis with '1972, together with our partner Servier, we're doing an 850-patients, 52-week trial around the world in the ROCCELLA trial, so also a very exciting molecule, a very exciting program that potentially has tremendous value for both Galapagos and Servier. And then we have the PINTA trial, which is a new mechanism, '1205 that we previously tested in ulcerative colitis and now in IPF. We're running that for a 26-week trial with 60 patients. So all in all, we're moving over 2,500 patients in these programs. These are numbers that Galapagos has never seen before. So it shows how this company is developing in time.

So I'm bringing you to the next slide, which is a slide we have shown before, which you can expect in 2018 regarding our late-stage clinical news flow, so this excludes early programs as well as the whole research pipeline. But these were the objectives that we shared with you previously and you see we have most of them already achieved. One big [we had] cost at the second triple combo because as we decided not to move that forward, but all the others are nicely moving along with 3 achievements still to be made. Clearly the FINCH 2 data are eagerly expected by the market, which will be in Q3, which is filgotinib in RA. This is the first Phase III readout that Galapagos will ever have -- will have. So it's going to be eagerly awaited by us, Gilead and of course, everybody that follows Galapagos. But also very excited about the Phase II trial of filgotinib in ankylosing spondylitis, the TORTUGA trial of which the data will also be presented in Q3.

So these are very important moments in the history of the company. And then we also will present in the second half, the FALCON data, the triple combo in cystic fibrosis. As I said, this is fully screened and the whole timing of that trial is according to planning. So all in all, I think 2018 is going to look like a fantastic year for the company to -- with regard to the development objectives that we set.

We also signed in this quarter, the licensing deal around MOR106 with Novartis. MOR106 is a partnership around an antibody that's targeting IL-17C that we have in combination with MorphoSys. We have this target originated from the target discovery engine of Galapagos and we have jointly moved this forward through discovery and through development where we showed the proof of concept data to the market and based on that, we started our Phase II trial and we initiated discussions with parties to see if we find the right licensing partner for this program, and ultimately, we're very pleased to sign this deal with Novartis, of course, one of the leading pharma companies in the world. Very well-respected partner, and we are extremely excited because of the plans that Novartis has with this molecule antibody that we have. They will move this in multiple indications. They have committed to at least 2 new indications, so on top of the current indication in atopic dermatitis. Also nice is that they are going to pay for all the cost that we further incur on Phase II trials, so they take over the complete expenses of that program and that's considerable because it's a large program that we are executing.

They are responsible for the whole Phase III and commercialization and in exchange for this license of the program, they pay MorphoSys and Galapagos an upfront of $111 million that we share 50-50, milestones up to $1 billion and royalties in the low teens and low 20s. That deal has been signed, but still needs antitrust clearance that we're expecting in the not too far future. So an exciting deal and we think it's the right thing to do for this program to partner at this stage. The terms are nice, the partner is fantastic and we will be running this Phase II program as we had planned so we're still in charge there.

So all in all, I think we can be very proud of this program and the results.

So with that, I would like to hand it over to -- no, this is the next slide? To Bart, yes.

Yes. Thank you, Ono. Let me show you a couple of slides on the key financials and as you usual, I will start with cash burn. Our first 6 months of the year has been EUR 95 million. As you can see on this slide, we've had small positives from small capital increases as the result of warrant exercises as well as more currency translation effect, which is positive this first half year. Those two, we never take into account in our operational cash burn. Our cash burn definition includes cash income from milestones and all other cash expenses leading to a result of EUR 95 million over the first half year and giving us a cash position of EUR 1,067,000,000 by the end of June.

Then key P&L figures on the next slides. Revenues are up by almost EUR 30 million to little over EUR 100 million. Be aware that this is, to a large extent, driven by accounting treatments. There is clearly an increase in the recognition of deferred revenues that are associated to be upfront that was paid to us by Gilead for the filgotinib transaction in 2016. And at the same time, there is also a change in accounting standards with implementation of IFRS 15, which had a net positive effect of a little over EUR 10 million over the first half year.

Operating costs are expenses associated mainly with research and development clearly. Research expenses slightly up, but the real increase is in development expenses and clearly associated with filgotinib, '1690 and CF and that's a trend that we will expect to see also going forward in terms of increases as these programs that [Onno were --] was just describing are coming online and we're running more and more of our proprietary programs. Net result is negative EUR 59 million, which is EUR 10 million worse than the first half of 2017, which is the combination of the 2 previous components as well as some currency translation effects in between, again, the large extent driven by accounting treatments.

Then finally, maybe a quick word on guidance. We've lowered our cash burn guidance for the year 2018, originally we had EUR 220 million to EUR 240 million as a range. We expect to receive 50% of the upfront that was paid or that will be paid by Novartis for the MOR106 transaction and as a result, we're lowering the guidance for the full year 2018 to a range of EUR 180 million to EUR 200 million.

And with that, I think we will close our prepared remarks and will hand it over to -- back to Elizabeth for the Q&A.

Okay, thank you. And that does indeed conclude the presentation portion. I'd now like to ask the operator, Abby, to connect us to any callers with questions. Abby, go ahead.

(Operator Instructions) And we will take our first question from Matthew Harrison with Morgan Stanley.

Two for me. So both related to filgotinib, I guess the first question is, can you just give us an update on the male toxicity study? On clinicaltrials.gov, it suggests that won't read out until 2021. I'm just wondering how that impacts time lines for filgotinib and how enrollment is going with that study. And then, secondly, could you just also talk about -- I noticed that you started filgotinib study, or maybe Gilead did, with hepatic impairment. Is there a specific reason for starting that study or is that just the standard requirement as part of the package you need to deliver to the FDA?

Matthew, this is Walid. I'll take both questions. I'll start with the easier on first. So for the hepatic impairment study, this is the usual clinical pharmacology package that one does when submitting this, so there's no particular reasons why we did it in the case of filgotinib. It's just a regular completing the package and preparing for filing. Regarding the male toxicity study or sperm toxicity study, so as you heard last week in the Gilead Q2 results, that this will be part of the overall package that we submit to the FDA. Gilead is doing everything they can to work on MANTA recruitment and move it as quickly as possible. I'd like to point out that we have been quite impressed with the speed with which Gilead performed our FINCH trials as you should recall, we kind of wrapped those up a bit 1 year ahead of schedule. That also included an update on the -- what's available on clinicaltrials.gov, which sometimes it lags behind how things are progressing. So what I can tell you is, Gilead is working diligently to recruit the MANTA study. They're quite focused on this and moving this along and once we have more information, we'll be able to share with you an update on timing of the filing for filgotinib.

We will take our next question from Nick Nieland with Citi.

I've got 3, please. So just to clarify on the last question, what's the earliest possible timing do you think for filing oral filgotinib in RA? So is it that you have to wait for the final FINCH 1 and 3 data and you have to wait for the MANTA trial to actually read out before you can actually submit that package? And then secondly, do you think that Gilead will use a priority review voucher for that filing? Second question is on cystic fibrosis. Is it your intention to take the second triple combination into Phase II once you resolve this dispute with AbbVie? And is that likely to involve another partner or is that something you could take on yourselves? And then, just how much should we expect on data ramp up now in second half of '18 and 2019, given all of these -- the successful progression of your pipeline?

Okay. So maybe I'll take the filgotinib question regarding MANTA. So at this point, we're not really prepared to share any specific timing regarding the filing. As you know, we need to complete the whole program, and have been communicated, we will get results from FINCH 2 later this quarter and then FINCH 1 and 3 will be in early 2019. And then, we will have to look at the totality of the data and include data from the MANTA including -- into the package. So at this point, we cannot guide on the exact timing, but we're doing the best we can to move forward. Regarding Gilead's use of priority review, I think this is a question that's probably better addressed to Gilead. I cannot make a comment on this at this point, but we should hope they will. That is our position.

Yes. I'll answer this -- the CF question. There's not much we can tell at this point in time over what we have expressed in our press release, the fact that we're clearly -- we're not pleased by the decision by AbbVie not to move the second triple into patients and we are reviewing our partnership and that's the only comment I can make regarding CF at this point in time.

And I'll take the last question, Nick, around the ramp up of R&D expenses for the second half of the year. So our guidance points towards in -- to the higher end of that range was EUR 200 million, which includes, I'm rounding now roughly EUR 50 million of income from the Novartis transaction, so the actual gross expense expected for the second half of the year is around EUR 150 million, and that's a number that we will expect to continue into 2019. I'll get back to you all with more detailed guidance as usual around the full year results' [core] information, but clearly that number will not go down. It will rather go up from that level.

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

One on MOR106, and one on CF. So on '106, wondering if you could talk a little bit about some of the other indications that might be contemplated beyond atopic derm and also if you could give us any sense as to how the overall milestones may be allocated? Should we think of those as primarily regulatory commercial or might you realize material amounts for development in the coming years. And then on CF, on the PELICAN study, wondering if you guys have seen any evidence that the Orkambi backbone might have interfered, if not with exposure, then maybe with measurement of FEV1, such that, we might expect a triple combo to show more impressive benefits overall when we see the FALCON data.

Brian, thanks for asking the questions on MOR106. For the extra indications, I think the easiest way to answer the question is to refer you to the panda paper, which came out a couple of months ago. And which is a very nice piece of research that really points to the importance of the IL-17 pathway in a number of TH 17-induced diseases. So I can't comment on specific indications because I -- we will do that at the moment we announce the study. But we've had a very interesting and deep discussion with Novartis as you can imagine, on how we want to develop MOR106 globally. And that paper really points you to a number of diseases, which are on the board now and we will keep you informed as we move forward. But that panda paper is 2018, gives you nice indications. Then on CF, moving to CF, the PELICAN study, so prior to starting the PELICAN study, we had a good idea on how much of PK interaction we expected from the Orkambi, let's call it backbone [here arc] treatment on '2737. In terms of exposures, we were fully in line with our expectations with patients, so we really reached our target levels there. And so for sure, it's not PK interaction. What you then point to is sometime negative impact of Orkambi on lung function. We don't have the impression that has happened, that typically happens at the start of the treatment of Orkambi and then goes away over time, but that [effect of issue] is at the beginning and most of these patients were on treatment for average couple of years. So we don't expect that, that plays a significant role in unfortunately the limited efficacy we saw in the PELICAN study. And I think I answered -- and there was a question on [efforts for Bart on the MOR106 extra milestones. Bart, do you want to tackle that?

Yes, I'll take that piece. Yes, Brian, the question you had on milestones. So we need not to detail all the milestones stage by stage, but what I can tell you is that a significant majority of the milestones are associated with development and regulatory events and a minority is associated with sales figures. And obviously within the development regulatory, the larger numbers are around the regulatory events and the smaller numbers around development, but not insignificant for us either.

We will take our next question from Sandra Cauwenberghs with KBC Securities.

I have one other question on MorphoSys 106. I was wondering, besides the other indications, if there has been any communication on the potential combination trial for instance with Cosentyx or if that could be an interesting rationale? And with regards to '1690, if you could give us some information on the time lines of the 2 global trials? Total duration? Recruitment time? Et cetera.

Okay. So this is Walid. I'll take the '1690 question first. So as we've communicated before, these will be 2 large, identical studies, 750 patients each, conducted worldwide for a total of 1,500 patients. The in-life phase of the trial is 52 weeks, but there were some specific elements in that the patients will continue on the randomized treatment until the last patient finishes 52 weeks of treatment. We expect to start the trials, as Onno mentioned, very shortly and those will be conducted worldwide. In terms of the duration of the trials, we were not guiding yet on how long it will take us to recruit, simply because it's too early. We haven't yet seen any performance, how it goes and so on so forth. As you know, our trials are really on top of center of care including those who are on any -- on antifibrotic treatment such as pirfenidone and nintedanib and those who are on none. So believe this will make it relatively easier to remove some of the hurdles, yet we're dealing still with a rare disease and we're talking about a large program of 1,500. So we have all the resources behind it. We're well prepared for it, but as of today, I cannot give you any guidance as to the duration of the in life or the recruitment time line for the trial. Off to you, Piet.

Yes. Okay, Walid, thank you. On the MOR106 question, of course Novartis was a very interesting candidate for IL-17C to license another a major player in that IL-17 space. The plan currently is that we execute the Phase II plan as we had it on the books, so this is first dose ranger IP, plus a bridge to a subcu. So a subcu [first] and then later a subcu efficacy study. And from there on, Novartis will take over for Phase III. And if they want to combine the IL-17A, then that will be part of that program, but I can't comment further on combo trial that they want to plan currently.

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

This is Edwin, on for Adam. My first question is on filgotinib, a more general one. So the FINCH 2 top line data around the corner. Can you please remind us what do we expect in efficacy like ACR scores and safety from this Phase III trial? And how do we think of market positions of filgotinib relative to other JAK inhibitors in terms of developmental stage and potential usage in RA patients?

So maybe I can take this question about our expectations. You've heard -- you've seen the data so far with our RA program with a number of Phase II trials in RA. You've seen the recent data in psoriatic arthritis, where filgotinib performed in this trial better than anything that has been reported so far. You've seen our data also in the control trial in Crohn's disease. I think we have a compound that so far has demonstrated time and time again in well-controlled -- placebo-controlled and well-designed trials, where we have remarkable performance in efficacy. In addition, our safety profile continues to demonstrate as the data are being accumulated a best-in-class profile. And all of this as you guys know is not surprising because of the high selectivity for JAK1, which we think is where we need to be. So I would imagine that the Phase III trials or I would expect actually, that the Phase III trials with filgotinib in RA, and also in IBD later on, will continue to demonstrate a superb efficacy, along with the best-in-class safety, so that we can combine to have the -- actually an excellent or outstanding risk/benefit profile for this. Was there a question on positioning as well? I wasn't very clear. I might have not caught it. I'm sorry, Adam (sic) [Edwin].

Yes. It's in clinical settings, if it's after approved, so relative to other JAK inhibitors.

Well, look, I think the -- we will have to wait until we have the totality of the data for Phase III program to be able to make that statement with more confidence. But so far, based on the data that we've seen today and based on what we know about the drug and its selectivity and it's emerging safety profile, we expect it to be best-in-class. And then if you're best-in-class, you'll be used much more commonly than otherwise. It's very difficult to make predictions without that data, but so far, the -- what we know of promises to be a very good profile at the completion of Phase III.

Okay. My second question, can you please give us some updates on ROCCELLA Phase II trial with '1972? How many osteoarthritis patients have been enrolled? And when do we expect some data results?

Yes. Good questions. So this is, as you've heard, a large trial, 850 patients will be randomized across the world. We are responsible for the portion of this in the U.S, which is approximately 300 patients. This study is imminently ready to start, so we should be recruiting in the next few weeks. Again, in terms of how long it will take to complete the trial, it's a bit premature to say at this point. We will have to see how things go. But again, we are working with a partner who is well experienced in this space and we have a lot of excitement as this mechanism of action really promises to be very good in this space, especially having demonstrated some proof-of-mechanism in patients already with OA and the safety profile that so far, looks very promising. So I think these will help us with recruitment, but I cannot really give you any guidance on time lines today. It's a bit too early for that.

We will take our next question from Emily Field with Barclays.

Just on filgotinib. Going to back the end of Phase II meeting, it has sort seemed that the question of male toxicity in RA had been result given the dosing schedule that you were going into the FINCH program with. So I just want to confirm that nothing has changed and that there haven't been any sort of incremental safety signals that you've seen, aside from what was initially seen in the preclinical data.

Thanks, Emily for your question. No, there's been no new development that would make you feel any more concerned or any new data that emerged. This is the usual point that we need to have, the totality of the data, so we have to make a risk/benefit assessment across the board. And when you see in the FDA, the way they evaluated a number of compounds in this space, particularly the JAKs, in addition to others, they like to look at the totality of the data and at the end of day, it's a judgment that has to be made on the risk/benefit. But I can confirm there has been no new development that could change the course forward since we had the end of Phase II meeting.

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

Just a couple on cystic fibrosis. I guess first is on the collaboration with AbbVie. You mentioned that you're in the process of reviewing the collaboration. What are the dispute resolution procedures in that collaboration? And according to the collaboration, can either party discontinue at their own desire or is there something else that needs to happen to get out of that collaboration?

Yes. This is Onno. Unfortunately, I cannot get any more specific on the CF situation with AbbVie than what I've told previously. So yes, I have to leave you in the dark here.

Okay. Then the follow-up on the CF program, it's just on the FALCON data. I think the guidance is for that data later this quarter. Will we be getting both doses in that initial release or will it just be dose A?

Okay. Thanks for going back to science now. So indeed, as you mentioned, we have the FALCON study ongoing. So the news there is that we have recruited fully the Trust cohort and the Trust cohort will contain 1 dose only. So all patients -- this is open-label trial. So all patients are on the same regiment and all on the same dose.

And when could we see dose B? Is that sometime later this year?

Well, as the trial is fully recruited and dosing is for about a month, so around the end of Q3, we should have all data and have it analyzed. So it can be within Q3 or early October, something like that [to have the data...]

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

Couple of left on CF, I think. Just on the second triple, it was my understanding that Galapagos leads development until proof of concept has been demonstrated. So I guess I'm just curious, given the way that relationship is run, why can you not continue development of second triple as AbbVie doesn't take over the responsibility until after that proof of concept data have been shown? And secondly, I think in CF a milestone, if I read the financial report right, was hit during the second quarter, triggering some money from AbbVie. Just inquiring as to what that milestone was that triggered that money in 2Q? And then just a bit of an [aim on] financial one, but depreciation and amortization ticked up quite a bit in 2Q. It's a small number, but what was the rationale for that?

Okay, I'll take the first one. Again, I cannot go into specifics. It's clear that for us to take the triple into patients, we need the okay from AbbVie to do so. And they didn't give the okay, so we couldn't move that into patients. So that's the only thing I can say over that part of the contract. The other questions will be answered by Bart.

Yes, Peter, so the milestone -- you're correct. There was only one milestone that was connected to completion of the Phase I of our triple, including '3067 that was completed. And the milestone achieved in the second quarter. And on the amortization point, it's a really small amount, but there was a very early-stage compounds on which we had to amortize a -- I think it was a little more than EUR 1 million amount in the second quarter as well.

We will take our next question from Anastasia Karpova with Kempen.

Two quick questions on the FINCH 2 program. Compared to baricitinib and upadacitinib trial, you have quite higher proportion of Japanese trials. In regards to that, would FINCH program be sufficient to support filing in Japan as well or is there a plan for a separate clinical program? And second, do you observe any significant deviations in terms of the placebo rates in Japanese populations compared to the western one?

Okay. So this is Walid. So yes, indeed, the plan would be to have enough patients to be able to file in Japan at the completion of the program. That's still our plan. In terms of difference of placebo in Japanese patients, I'm not aware of any significant differences of concern or concerns. So I'm going to say, no.

Our next question is from Hugo Solvet with Bryan Garnier.

Just one on MOR106. Could you give some indication on the positioning that will be seeked by Novartis, with respect to dupilumab?

Hugo, thank you. So I think it's a bit early to already compare MOR106 to the [-- with the drug] that target the same disease and [clearly] the same patients. But we are early in Phase II. It has shown promising efficacy, [up par] maybe somewhat better than dupilumab. And of course, over time, we will watch how long the efficacy stays with dupilumab and so it's a bit early, I think, to say they're going to be better or similar. But we are hopeful that will at least match the efficacy once we have those data, Novartis can then decide how to position it in the market.

(Operator Instructions) And we have no additional phone questions at this time.

All right. Well, thank you, everybody. This does conclude the Q&A part of the call. Please note that our next planned financial results are expected on October 25. We thank everyone for participating today and hope you have a great day. Thank you, bye-bye.

Ladies and gentlemen, this concludes today's call. Thank you for your participation. You may now disconnect.