Galapagos NV

Good day and thank you for standing by. Welcome to the Galapagos Q1 2023 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sophie van Geesel. Please go ahead.

Thank you, operator. And thank you and welcome to the audio webcast of Galapagos' first quarter 2023 results. I'm Sophie van Geesel, Investor Relations, representing the reporting team at Galapagos. This recorded webcast is accessible via the Galavgos website homepage and will be available for download and replay later on today. I would like to remind everyone that we will be making forward-looking statements during today's webcast. These forward-looking statements include remarks concerning future developments of the pipeline and our company and possible changes in the industry and competitive environments. Because these forward-looking statements involve risks and uncertainties, Calabco's actual results may differ materially from the results expressed or implied in these statements. Today's speakers will be Paul Sofos, CEO, and Bart Filius, President, CEO, and CFO. Paul will discuss the Q1 highlights and provide an update on our immunology and oncology portfolio. Bart will go over the commercial and financial results. You will see a presentation on screen. We estimate that the pre-paid remarks will take about 20 minutes. Then we'll open it up to Q&A with Paul and Bart, joined by Michele Mantel, Chief Commercial Officer, and Daniele D'Ambrosio, Head of Immunology. And with that, I'll now turn over to Paul.

Thank you, Sophie. Good morning, good afternoon, and thank you for joining our Q1 results highlights. Let's take a moment to look at the highlights as presented on the slide here. To first take on immunology, while we were very disappointed with the outcome of the Crohn's disease study, We are happy that we recently dosed the first patient in the phase 3 registrational study with Fulgotinib in actual spondyloarthritis, a potential third indication for Yoselica. In addition, we are opening clinical sites for our phase 2 study with a TIK2 inhibitor and should dose the first patient in the coming days or weeks. Moving to oncology, we presented very encouraging safety and efficacy results for 5201, a CAR-T CD9 CAR-T in CLL at the EHA meeting in February. We'll come back to this data later in the presentation. Meanwhile, we are expanding our Cocoon network and making good progress in opening additional sites in Europe and our first sites in the US. On a corporate level, we took important steps in executing the strategic reorientation of our company. Importantly, we successfully transferred our drug discovery and research activities in Romainville, France, to Novalix, a French drug discovery-focused contract research organization. We are extremely pleased with this transfer, as Novalix is a good home for our French colleagues, and it fits very well with our strategy to build fit-for-purpose R&D organizations. Here you see our pipelines. As mentioned, the pipeline is refocused on two therapeutic areas, immunology and oncology. And I will go in a little detail over different programs. I'll summarize them. In immunology, as mentioned, unfortunately, the Crohn's disease did not give us the expected results. But we have RA and UC on the market with a registrational trial in AXPAR out of the gates now. We are progressing Arctic 2 in SLE and AIM. in TIK2 in dermatomyositis, sorry, and also in SLE, and aim to start a patient study with our CD19 CAR-T in SLE later this year. Meanwhile, we are working on multiple preclinical targets that we are eager to push forward and see if we see a better class profile. In oncology, we are making good progress with the CD19 programs. Happy to report that this morning we received the approval to start a clinical trial with our BCMA program in multiple myeloma. And meanwhile, with the bound, as well as via external collaborations, we are progressing with multiple new targets, developing our new next generation CAR T's for the point of care units. In immunology, we are focusing on all steps of the research progress. initiating new preclinical research programs on best-in-class targets. We are merging our CAR-T capabilities with our immunology team in the CD9 team for lupus. The TIK2 is progressing as a late-stage molecule, and filgotinib is expanding the indication. So we keep strongly focused on immunology. A little bit more explanation on axial spondyloarthritis study. AXPA is a disease with inflammation of spine and the sacroiliac joints. It's a very heterogeneous disease. It affects young people with low remission rates today. Patients have limited option with currently available drugs and there are no new modes of actions expected in the coming years. The Tortuga data in AXPA was communicated in 2018 and published in the Lancet provide the comfort to go into AXPA with filgotinib. And this is also shown in a graph on the slide. The 200 milligrams show strongly significant effect size in mean change from baseline in the ASDA score compared to placebo. Early onset of action is visible already at week one of the treatment with continued response till week 12. So good hopes in this indication. The start of the Olinguito phase three in AXPA with filgotinib is in non-radiographic and radiographic disease. A total of 238 patients will be included, either in placebo, as you see on the slide, or 200 mg filgotinib. The primary endpoint, ASAS40, is at week 16, and patients will be able to enter into an open-label part of the study until week 52, which will report also stop-line results. Start anticipate next quarter, the second quarter, with top line in 2025. From week 52 in the study to week 104, we plan to re-randomize the patients who achieved low disease activity at week 52 to study either the 100 milligram or 200 milligram until week 1-4. The design is endorsed by the authorities and good to go. As indicated, the TIK2 study, the GALARISO trial, is currently active underway and set out in the fields to start recruiting patients. It's also a placebo-controlled study in 62 patients for 24 weeks with a four-week follow-up in patients with active dermatomyositis and reduced muscle strength. The top-line results are expected in the first half of 25. As a reminder, with the same molecule, we also start an SLE study which should result also the second half of 25. In oncology, as I explained last time at the meeting, we are very much focused on our point of care network for CAR-T. And this slide shows how we changed the paradigm of CAR-T treatment by the way of decentralizing production with a cocoon platform, which we brought in to Galapagos with the acquisition of CellPoint. In collaboration with CellPoint, we are now developing these new products. The decentralized has the benefit to give a short seven-day vein-to-vein time. We at the moment run this production in the hospitals with a very high success rate as we are running now two kilocontrials and soon three. On the next slide, you see the cocoon. On the left side, you see the cartridge. the whole cocoon in its environment, and then you see also the future where we can put many cocoons on the stack in order to reduce GMP unit space. This is complemented with the development of a digital and data system which collects and registers all the data, allowing us to do at the same time the quality control, quality release, allowing the seven days vein to vein. As I said, very consistent production over the centers, and we have close to 100% delivery of two patients here. The next slide shows you the data which I talked about in CLL, the study design at least. Three dose levels are being studied in a phase one two dose finding study in CLL in the point of care. With encouraging data, we presented at the EBMT EHA conference in February. Data on two dose levels are available. The third dose level is currently being tested. Important here is that we include Richter's transformation patients, which typically is not the case in CLL trials, and we see very good results. I'll come back to that in a minute. We aim for the top-line results of the three dose levels of mid-23 and the data will be presented at ASH later in the year. Here the next slide shows you the first data and shows that we have an overall response rate in six out of the seven patients, seven out of seven patients, with six out of seven having a complete response. And on the right side of the slide you see a patient with Richter's where after 28 days the patient is in complete remission and no disease is detected anymore with biomarkers in the body of the patient. The swimming plot of the patient shows you that in the two different levels, all the responders, overall responders, and all the complete responders, with one patient relapsing after five months with CD19 escape. What is very encouraging here is that all the patients with Richter's transformation had a complete response. We are further recruiting into these studies, and as I said, an update will be given later in mid this year, and the data will be published as we go on the large conference. We continue on the safety side to prove the safety of the product. Also, again, remarkable, we don't see a grade three or four CRS in any of the patients in the two dose levels we tested so far, and also no neurotoxicity icons as we have observed in the whole study. So overall, high efficacy, very complicated patients, and very good safety profile. At this moment, I would like to transition to Bart. It's an important meeting. It's Bart's last call, as you probably have heard in the press earlier this week, because Bart is going to leave us. I want to thank Bart for his contribution over nine years to the company. He has been the leader of introducing us on Nasdaq. He was instrumental in getting the Gilead deal done. He built the European commercial organization and so much more. Very important was that Bart was on my side to transition into Galapagos, and we have had a very productive collaboration over the last 14 months. So Bart, I give it to you.

Thank you, Paul. Thank you for those kind words. Good morning, everyone. Good afternoon. Indeed, this is going to be my last webcast. I also would like to express, first of all, my thanks to all of you, shareholders, investors, analysts, and anyone else listening into this call and previous calls. We went through it together and some ups and some downs. But again, thank you for following this story, for following Galapagos. It's been really a fantastic nine years at the company. But now, after having been able to support the leadership transition over the last 12 months, the time really has come for me to explore new opportunities. Having said that, I'll go to, for the last time, the financials and operational details right now, and obviously we are all available for Q&A right after. Starting with Jycellica sales. Honestly, Jycellica sales were a bit disappointing for us in the first quarter. They were really weaker than anticipated. It looks like the impact on the JAK class in terms of market share in advanced therapies has been stronger than what one would expect based on the actual outcome of the FRAC review and the label change. So it looks like doctors take a conservative approach, at least in the first reactions and the first resulting market shares. Now, it's very early days. It's really one quarter, and we're really in the midst of evaluating the impacts of the label change, the impact of how it's perceived in the market, but also the duration, whether we're talking about, let's say, a quarter of slow growth or whether it's actually a longer duration impact. So as a result, we've decided to revisit the guidance at the Q2 call in early August. So today we are neither withdrawing nor confirming our existing guidance. But it goes without saying that we will need to see real strong return of quarterly growth as of Q2 to really reach our original guidance range. So a bit disappointed in terms of in terms of impact in Q1 of Jaisetica sales. Then if I go to the next slide, say a few words about our cash position, 4 billion at the end of Q1 with a 99 million quarterly cash burden. As you know, we are confirming again our full year cash burn range of 380 to 420, so the 99 million fits perfectly into that trend after one quarter. Obviously, another element of interest I think for all of you and definitely for all of us is the treasury management around cash in two dimensions, one from a risk management point of view and secondly from a return point of view. Happy to say at least that on a risk management point of view, we've not been exposed to any of the financial institutions that went into trouble over the last quarter. We have a very, very conservative investment policy. We spread our total cash balance across term deposits at financial institutions of the highest grades, money market funds that can also deliver diversity in investments, and also T-bills up to AAA-rated T-bills. So, conservative approach. In terms of Euro-dollar, second question I've been getting a lot over the last period, we are still approximately 80% in Euros, 20% in Dollars. We are a Euro-denominated company. We do not want to take exposure on the dollar beyond what we believe is our operating exposure in the future, and we've estimated that to be about the 20% mark. Then on the return side of cash, we're really happy that obviously that we're starting to get into positive interest rates territory. We think actually that over the full calendar year, our return on our capital can reach a level of approximately 3% on the total outstanding balance on average. It's a little less in the earlier quarters, a little more towards the end of the quarters. We were invested very short, but some of these T-bills and term deposits obviously need to unwind from previous quarters. I would like to stress, however, that not all of the 3% you'll find back in our cash burn or our cash inflows, because some of this invested, for example, in money market funds ends up to be a fair market value effect, which you find in the middle category here also on this chart, which also includes currency exchanges. So cash burn wise, it will not be around the 3%. It's going to be probably more around the 2%. But in terms of actual results that we reach, that sort of the range that we anticipate, that's what you will see reflected also in our cash balance at the end of the year. If I then go to the P&L, we had a good quarter from a P&L point of view. We ran a profit of 23 million. A big driver thereof is revenues. Revenues were significantly higher in revenue recognition for Filgotinib. The key driver for that is unfortunately a negative event, which was the diversity study. As a result of the diversity study, we have cut down the development budgets for the future, obviously we're not going to invest in Crohn's from here on. And as a result, our percentage of completion, it's a bit technical, but that's the way we account for this, our percentage of completion of the Forgotten Development Program has effectively gone up because the total expense has gone down. And then we recognize this is a one-off effect of about 50 million in our first quarter in the revenue line. Revenue recognition for the platform is stable at 58. And we talked about the sales levels for Gessetica previously. Operating costs are flat versus last year, which is a bit of a mixed effect between, on one hand, oncology going up, some other expenses going down. And indeed, interest income is supporting our net results, giving us a net profit for the quarter of 23 million. So far with regard to the financials, then let me conclude by the outlook slide. The key top line results that we are anticipating this summer the results with the NHL and the CLL trials with 5101 and 5201, the CD19 programs that Paul has spoken about. On regulatory process, we have the CD19 IND submission still to go, but we're happy that we've also now gotten the approval for the CTA approval for the DCMA program in-house. And in terms of trial initiations, the AXPA trial has started. Dermatomyositis and lupus will start shortly. We have also the plan to start a CD19 trial in lupus later this year with our CAR-T program. And then we are also intending to start the expansion cohorts and the phase 1-2 with the PCMA as well is going to start shortly. And then finally, we are very active also on the BD front. We also aim really to execute on additional BD deals in calendar year 2023. Let me conclude with, again, saying thanks to you all and hand it over to the operator for the Q&A.

Thank you, Paul and Bart. That concludes the presentation portion of today's audio conference call. I would now like to ask the operator to open up the line for Q&A.

Thank you. As a reminder, to ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. We ask all participants to limit your questions to only one. To withdraw your question, please press star 1 and 1 again. We will take our first question. The first question comes from the line of Brian Abrahams from RBC Capital Markets. Please go ahead. Your line is open.

Hi. This is Joe. I'm for Brian. Thank you for taking our question. Could you share your view on how much personnel for quality control and manufacturing release that will be required at each site and whether it is different in between U.S. and Europe? And when thinking about the model, are you thinking more so for point of care at each individual facility or more of a regional hub and spoke model? And could you also briefly talk about if any of these CAR T cell studies will be read out and will be conducted in the U.S. sites?

Thank you. Okay. So on the first point on how many people will be needed, it's a highly hands-off production process where at certain points, day one, for the startup and later in the process, the last two or three days are more intensive for the quality release and the quality control. So depending on the quantity of cocoons in a unit and the number, you talk about three or four people per center at the moment what we see in clinical trials. And that's to make sure that there is 24-7 coverage or on-call Most of the time, 90% of the time, the cocoon works independent from handling. So it's a fully automated system with when it's set up and then the quality control. On the second thing, we go fresh vein to vein. So we are currently focusing on sites close or in the hospital. Of course, if you're in cities and you have a 30 or 45 minute drive, you can use the cocoon for several hospitals from one center, and that's happening already in certain parts of our clinical trials. So how regional? In Belgium, in Europe, when hospitals are close to each other, yes, in the U.S. regional means something else. So we'll have to see how that will function. And then, yes, we are starting centers in the U.S. A set-up time, a selection and set-up time is six to nine months. So our people are now looking at different hospitals and different regions. At the East Coast later, we'll do other parts of the U.S. to start up our clinical trials, hopefully in the next 9 to 12 months in the U.S.

Thank you. That was super helpful. And if I could ask a quick follow-up. There seems to be a lot of interest in carcass cell programs in lupus. So just And obviously, you have a really good relationship with Gilead. So, I mean, I'm just wondering if anything that can be leveraged there. It also sounded like Gilead might have an interest in the area as well. So, I just wanted to see if there's anything that can be leveraged there or if there's any, how are you thinking about additional opportunities beyond lupus?

Yeah, there is this first loop of study which was surprisingly positive, and so not impossible. There are other fields in autoimmune diseases which could be new indications, but it will start with small patient studies, and I'm pretty sure that a lot of academic centers are already testing in these areas, so as information on clinical information on this use in autoimmune disease patients starts to come up, we'll definitely step on it. We have no basic research in this space. We follow the academic field here, and we collaborate with the academic field in order to get into new indications. Thank you.

Thank you. Thank you. We will take our next question. And your next question comes from the line of Mike Olds from Morgan Stanley. Please go ahead. Your line is open.

Hey, guys. Thanks for taking the question. Maybe just one on Giseleca sales trends throughout the quarter. Just curious if you can give us a little bit more color on what you were seeing sort of through the months of the quarters. Is there sort of a steady downtrend, or is it flattening, or is there increasing pressure here? And to the extent you can, maybe give us a little bit of your thoughts on how to think about 2Q. Thanks.

Sure. This is Michaela. Thanks for the question. let me go to take a perspective of what happened at the end of the year the new label resulting from the article 20 procedure was communicated as a positive opinion and that concluded the process but at the same time gave some uncertainty in the prescribing physicians on how to interpret it and that's what we hear and what we see in the advisory boards and the inside collection has been the the situation in the markets, in the operating positions, in understanding how to apply it. So what we have observed is basically the adoption of JAKs for new patients to have gone down to be very conservative use. So that's what's happened in the process. Now, what we are seeing is that this uncertainty is being tackled. For example, the German Rheumatology Society has published guidance and a very clear checklist that indicates that JAKs can be used for non-risk patients, for any line of treatment, and for the smaller proportion at risk only after one failure of biologic therapy, so first switch. So that's very open for an increase again of the JAK class, but that needs to be then applied by the treating physicians in their practice. So the question now is how quickly they will take that new recommendation, that clarity, and to what extent they will apply it. And that's what we are observing. I mean, we keep observing, of course, continuously to determine how the trend will change. And that's the reason actually that we are taking the time to revisit the guidance and then come back in the middle of the year with the H1 earnings.

Very helpful. Thank you.

Thank you. We will take our next question. The next question comes from the line of Peter Vidal from Citigroup. Please go ahead. Your line is open.

Thank you, Peter Vidal. One question, one clarification, please. Just on M&A activity over and above, why haven't you been able to do more? Is it just a a function of unrealistic valuation expectations or not finding suitable assets that have a commercial therapeutic effect. I just want to get a better understanding of the landscape there. And then the clarification, Michele, is you've reiterated your cash burn guidance for the year, but said that you're going to come back to us in August with a revised or a maintained guidance for Droselica. So my clarification is that if you were to cut Droselica guidance, Would the cash bank go down with it, or are you saying there are steps for you to maintain that? I just want to make sure what you're exactly saying in the press release. Thank you.

On the first topic, on the business development, as you have seen, we have one sell point about June last year, which was, I think, a good hit for us starting oncology. But as the company was just entering with that oncology, we needed some time to build up capabilities, insights in order to do the next one. We have done in the meantime a significant number of visit analysis, a lot of inbound flow from companies who need finances and who are very open to collaborate. And we are now at the selection moment from this one or this one deal we are going to do. And you will see us moving in the next few months on additional uh deals but it it took us it took us almost a year to build the capability to integrate cell point and abound to attract new people and make uh and make the and be enabling us to make the right move as you know if you do an acquisition of a license it has to be the right one so you have to scan the environment you have to scan the competition you have to have a good insight on when we bring something in we have something which really will make make a difference. And so very proud that we were able already to start three clinical trials, three different molecules in clinical trials with CellPoint, two CD19s and now the BCMA, more to follow in immunology, but the BD you will see on the short time happening. We'll accelerate that before the year end significantly.

Okay, now I'll take the second part of the question about Casperin. So what we are confirming in the press release is the Casperin guidance of 382.420. So we are not planning to readjust that guidance depending on the outcome of the evaluation around the Gisellica sales guidance in August. We will make sure that through proper cost management and through effective basically managing within the range, we are able to maintain our target with regards to cash burn for the full year.

Thank you, Jan, and good luck with your next chapter. Thank you. Thank you, Peter.

Thank you. We will take our next question. Your next question comes from the line of Dane Leong from Raymond James.

Please go ahead. Your line is open.

Thank you for taking the questions, and Bart, it's been great working with you over the years. Best wishes on your next endeavor. Maybe two from us. Firstly, could you provide a little bit more nuance in terms of where you see the maximal interest rate blended on your current cash balance settling out. Is 3% the top number that you would expect going forward, or would that still be a blend that might go higher? And then secondly, in terms of the TIC-2 program, how important is success in dermatomyositis and other indications in leveraging the current infrastructure in place to commercialize Gisellica? Said differently, is the TIC-2 program success now required to make a positive ROI on the current commercial infrastructure, or can Gisellica still and is expected to provide a positive EBIT margin on its own sales over time. Thank you.

Yeah. Hi, Dane. Thanks for your words. Let me take the first part of the question, and then, Michaela, maybe you will take the second part of the question about the commercial and the TIC2. So on the interest rate, the 3% is a blended rate. So there is indeed, let's say, last quarter rates should be beyond that. Obviously, this is all dependent on where the ECB and the Fed will take us. But with the current expectations of the Fed reaching sort of the end of the curve at the moment, the ECB maybe 50 basis points away, we think we are going to be above 3% on average for new new term deposits and new money market fund performances. T-bills are generally a little bit below in terms of output, but on average between euros and dollars in the current environment we anticipate to be a bit north of 3% once we get to a stable level.

So I'll take the next question on the TIC2. So to start with, The guidance and the ambition we shared last year on Jaiselica was, per se, a positive business case. Remember the break-even and the profitability. Of course, this is part of the revisiting of what we are doing now to see how that goes. But part of the infrastructure we have built for Jaiselica in the core will also be instrumental to accelerate the start in oncology, which will be earlier in timing than a possible launch of the TIK2. So that will be an important infrastructure both at the headquarter functions and also in the countries to accelerate the oncology launch. And then, of course, looking at later in the decade, TIK2 or the lupus programs definitely will be able to leverage the infrastructure that we have built in the past years for JCELEC. Thank you.

Thank you. Once again, if you do wish to ask a question, please press star 1 and 1 on your telephone. We will take our next question. Your next question comes from the line of Jason Gerbery from Bank of America Securities. Please go ahead. Your line is open.

Hey, guys. Morning. Thanks for taking my questions. Just on Cocoon, I'm just curious how the process that you use in the clinical trials would differ from a likely commercial product and if there'd be ultimately additional work needed to be done at some point to bridge a clinical product or process to a commercial product or process. And are there any meaningful differences you'd flag in sort of the hurdle of the CTA approval process versus the IND clearance process? Thanks.

There will be little change to the production process. We are still optimizing the automation and the simplification of the quality release testing so that it is much more automated and

Please continue to standby. Your conference will resume shortly. Please continue to stand by. Your conference will resume shortly.

Please continue to stand by your conference will resume shortly. Yes, we can hear you.

Yes, we can hear you perfectly now.

Paul, do you hear me?

Okay, yeah, I'm back. I first want to apologize that this went wrong here with the phone. We are back. Sophie, can you hear us?

Yeah.

Yeah, please continue with the question. So, or should I repeat my answer to the previous one?

Maybe better, yeah.

Yeah. So, let me, the question from Jason was the Cocoon process in clinical trials versus commercial work, is there a lot of different work between the clinical trial application and the submission? No, we are finishing a number of simplifications at the cocoon. The process is very stable. We are integrating before the pivotal work the cell separation in the cocoon. When that's done, that process is final. And then we work further on the quality control and quality release by automating the testing so that in the hospitals, as minimal as hands-on work is needed, and open biology is needed, that sterility can be maintained, work is simple, everything integrated in the Xcelit platform. We succeed at the moment consistently in delivering cells from the machine into the patients within four hours. We can do the quality release at the moment within four hours. In the morning, the cells come from the instrument. In the afternoon, the patient receives the cells in all included in this seven day vein to vein process a second question yeah it was the cta versus the uh the uh imd no not uh we will be final at pivotal and we'll be able to submit uh with the pivotal process in the uh for the imd

Thank you. We will take our next question. Please stand by. And your next question comes from the line of Brian from Jefferies. Please go ahead. Your line is open.

Hi, thank you for the question. Just on BD again. Is the messaging still one additional product on the market by 2028, or has the more challenging dynamic

like a change that thinking i could be expected to shift to more mid late stage pipeline deals right yeah we are we are pushing very hard at the moment we predict one additional product by 2028 that will be most likely one of our car keys but we are very active in the oncology space um where there is potential for having more products. We can't promise it now, but as we go to the BD work at the moment, but also do our internal work with the next CAR-Ts, would we be able to bring two CAR-Ts by 2028 in different indications? As you know, we do the NHL with the one CAR-T, the CLL with the other, and then multiple myeloma to be expected, how we can fill in a high medical need. And the focus today with the cocoon is very much on Where can we fill the space where there's a high medical need, where seven days vein to vein in the hospital can play a real impact on patient survival? And so we are figuring out which are the short life expectancy status and diseases indications and that could yield. Today we stay with one. But we'll update as we go through our BD and our clinical work in the next 12, 24 months. Okay. That's good. Bye.

Thank you.

Once again, if you wish to ask a question, please press star 1 and 1 on your telephone.

There seems to be no further questions. I'd like to hand back for any closing remarks.

Thank you, operator. This concludes today's call. Please feel free to reach out to the IR team if you still have questions. Our next financial results call will be our H1 2023 results on August 4th. Thank you all for participating and have a great rest of your day.

This concludes today's conference call. Thank you for participating. You may now disconnect.