Galapagos NV
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Galapagos NV
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Good day, and thank you for standing by. Welcome to the Galapagos Q1 2023 Financial Results Conference Call. [Operator Instructions].
I would now like to hand the conference over to your speaker today, Sofie Van Gijsel. Please go ahead.
Thank you, operator, and thank you, and welcome to the audio webcast of Galapagos First Quarter 2023 Results. I'm Sofie Van Gijsel, Investor Relations representing the reporting team at Galapagos. This recorded webcast is accessible via the Galapagos 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, Galapagos' actual results may differ materially from the results expressed or implied in these statements.
Today's speakers will be Paul Stoffels, CEO; and Bart Filius, President, COO 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 prepared remarks will take about 20 minutes, then we'll open it up to Q&A with Paul and Bart joined by Michele Manto, Chief Commercial Officer; and Daniele D'Ambrosio, Head of Immunology.
And with that, I'll now turn over to Paul.
Thank you, Sofie. 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 a Phase III registrational study with filgotinib in axial spondyloarthritis, a potential third indication for Jyseleca. In addition, we are opening clinical sites for our Phase II study with a TYK2 inhibitor and should dose the first patients in the coming days or weeks.
Moving to oncology. We presented very encouraging safety and efficacy results for '5201, our CAR T -- CD19 CAR-T in CLL, at the EHA meeting in February. We will 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 U.S.
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 pipeline. As mentioned, the pipeline is refocused on two therapeutic areas: Immunology and oncology. And I will go in a little detail of the 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 the registration trial in AxSpA out of the gate now. We are progressing our TYK2 in SLE, and aim -- TYK2 in dermatomyositis, sorry, and also in SLE, and aim to start the 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 -- and if we see a best-in-class profile.
In oncology, we are making good progress with the CD19 programs. Happy to report that this morning, we received approval to start the clinical trial with our BCMA program in multiple myeloma. And meanwhile, with Abound as well, as well as via external collaborations, we are progressing with multiple new targets, developing our new next-generation CAR-Ts for the point-of-care units.
In immunology, we are focusing on all steps of the research progress, initiating new preclinical and research programs on best-in-class targets. We are merging our CAR-T capabilities with our immunology team in the CD19 for lupus. The TYK2 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 our axial spondyloarthritis study. AxSpA is a disease with the 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.
So the TORTUGA data in AxSpA, was communicated in 2018 and published in Lancet, provide the comfort to go into AxSpA with filgotinib. And this is also shown in the graph on the slide. The 200 milligrams show strong, significant effect size in mean change from baseline in the ASDA score compared to placebo. Early onset of action is visible already at week 1 of the treatment with continued response till week 12. So good hopes in this indication.
The start of the OLINGUITO Phase III in AxSpA 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, are 200-milligram filgotinib. The primary endpoint, ASAS40, is at week 16. And patients will be able to enter into a open-label part of the study until week 52, which we'll report also as top line results. Start anticipated 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 104. The design is endorsed by the authorities and good to go.
As indicated, the TYK2 study, the GALARISSO 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 4-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 started SLE study, which should read out 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 change the paradigm of CAR-T treatment by the way of decentralizing production with our Cocoon platform, which we brought in to Galapagos with the acquisition of CellPoint. And in collaboration with CellPoint, we are now developing these new products.
The decentralized has the benefit to give a short, 7 days 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 2 clinical trials, and soon 3.
On the next slide, you see the Cocoon as -- 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 use -- GMP unit space. This is complemented with the development of data -- 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 7 days vein-to-vein. As I said, very consistent production of the centers, and we have close to 100% delivery of -- to patients here.
The next slide shows you the data, which I talked about in CLL. The study design, at least 3 dose levels are being studied in a Phase I/II dose-finding study in CLL in the point of care with encouraging data we presented at the EBMT-EHA Conference in February. Data on 2 dose levels are available, the third dose level is currently being tested.
Important here is that we include Richter's transformation patients, which are typically -- 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 3 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 had an overall response rate in 6 out of the 7 patients -- 7 out of 7 patients, with 6 out of 7 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 2 different levels, all the responders -- overall responders and all the complete responders, with 1 patient relapsing after 5 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 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 3 or 4 CRS in any of the patients in the 2 dose levels we tested so far. And also, no neurotoxicity or ICANS, 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 read in the press earlier this week, because Bart is going to leave us.
I want to thank Bart for his contribution, over 9 years, to the company with -- he has been the leader of introducing us on Nasdaq. He was the -- instrumental in getting the Gilead deal done. He built the European commercial organization. And so much more day in and day out. And 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. Thanks 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 this together in some ups and some downs. But again, thank you for following the story, for following Galapagos. It's been really a fantastic 9 years at the company. But now, after having been able to support the leadership transition over the last 12 months, the time maybe has come for me to explore new opportunities.
Having said that, I'll go through, for the last time, the financials and operational details right now. And obviously, we are all available for Q&A right after.
Starting with Jyseleca sales. Honestly, Jyseleca 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 drug 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 1 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 markets; 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 impact in Q1 of Jyseleca sales.
Then if I go to the next slide, say a few words about our cash position. EUR 4 billion at the end of Q1 with a EUR 99 million quarterly cash burn. As you know, we are confirming again our full year cash burn range of EUR 380 million to EUR 420 million, so the EUR 99 million fits perfectly into that trend after 1 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 2 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 a conservative approach.
In terms of euro-dollar, the 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 around the 20% mark.
Then on the return side of cash. We're really happy that -- obviously, that we're starting to get into a positive interest rate territory. We think actually that, over the full calendar year, our return on our capital can reach a level of approximately 3% of the total outstanding balance on average. There'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, you 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, , 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 EUR 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 filgotinib development program has effectively gone up because the total expense has gone down. And then we recognize this as a one-off effect of about EUR 50 million in our first quarter in the revenue line. Revenue recognition for the platform is stable at EUR 58 million. And we talked about the sales level for Jyseleca previously.
Operating costs are flat versus last year, which is a bit of a mix 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 EUR 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 are 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 BCMA program in-house.
And in terms of trial initiations, the AxSpA 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 I/II with the BCMA 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 I 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.
[Operator Instructions]. The first question comes from the line of Brian Abrahams from RBC Capital Markets.
This is on for Brian. Could you share your view on how much personnel for quality control and manufacturing release 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?
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 1 for the startup; and later in the process, the last 2 or 3 days are more intensive for the quality release and the quality control. So with -- depending on the quantity of Cocoons in a unit, in the number, you talk about 3 or 4 people per center at the moment, what we see in clinical trials. And that's to make sure that there is 24/7 coverage, are on call. Most of the time, 90% of the time, this -- the Cocoon works independent from handling. So it's a fully automated system when it is set up, and then the quality control.
On the second thing, we go fresh vein-to-vein. So the -- we are currently focusing on sites close or in the hospital. Of course, if you are in cities and you have a 30- or 45-minute drive, you can use the Cocoon for many -- 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. The setup time -- the selection and setup time is 6 to 9 months. So our people are now looking at different hospitals in different regions in -- 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.
That was super helpful. And if I could ask a quick follow-up. There seems to be a lot of interest in CAR-T cell programs in lupus. So just -- and obviously, you have a really good relationship with Gilead. So I mean, I was just wondering if anything that can be leveraged there. It also sounded like Gilead might have interest in the area as well. So 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?
Yes, this first lupus study, which was surprisingly positive. And so most -- not impossible, there are other fields in autoimmune diseases which could be new indications. But it will start with a small patient studies, and I'm pretty sure that a lot of academic centers are already testing in these areas. So as information on -- as clinical information on this use in autoimmune disease patient 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.
Your next question comes from the line of Mike Ulz from Morgan Stanley.
Maybe just one on Jyseleca 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 quarter. Is there sort of a steady down trend? 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.
Sure. This is Michele, thanks for the question. So maybe good 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 the -- what we hear and what we see in the advisory boards and the incident collection, has been the situation in the markets, in the operating physicians, in . 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 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-at-risk patient, 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, right? 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.
The next question comes from the line of Peter Verdult from Citigroup.
Peter Verdult, Citi. One question and one clarification, please. Just on M&A activity over and above CellPoint and Abound. Why haven't you been able to do more? Is it just a function of unrealistic valuation expectations? Or not finding suitable assets that have a commercial therapeutic effect? Just wanted to get a better understanding of the landscape there.
And then the clarification about -- for 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 Jyseleca. So my clarification is that, if you were to cut Jyseleca guidance, would the cash burn go down? Whatever way, you're saying there's flex for you to maintain that. I just want to make sure what you're exactly saying in the press release.
So on the first topic, on the business development. As you have seen, we have done CellPoint, Abound. This is a very, very -- at June last year, which was, I think, a good hit for us starting oncology. But as the company was just -- is 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 deals.
But it took us almost a year to build the capability, to integrate CellPoint and Abound, to attract new people and make the -- enabling us to make the right move. As you know, if you do an acquisition of 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 a difference.
And so very proud that we were able already to start 3 clinical trials, 3 different molecules in clinical trials with CellPoint, 2 CD19s and now the BCMA. More to follow in immunology, but the BD, you will see on the short term happening. We'll accelerate that before the year-end significantly.
Okay. And I'll take the second part of the question about the cash burn. So what we are confirming in the press release is the cash burn guidance of EUR 380 million to EUR 420 million. So we are not planning to readjust that guidance, depending on the outcome of the valuation around the Jyseleca 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 regard to cash burn for the full year.
Bart, good luck with your next chapter.
Thank you, Peter.
Your next question comes from the line of Dane Leone from Raymond James.
Bart, it's been great working with you over the years. Best wishes on your next endeavor. Maybe 2 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 TYK2 program, how important is success in dermatomyositis and other indications in leveraging the current infrastructure in place to commercialize Jyseleca?
Said differently, is the TYK2 program success now required to make a positive ROI on the current commercial infrastructure? Or can Jyseleca still, and is expected to, provide a positive EBIT margin on its own sales over time?
Yes. Dane, thanks for your words. Let me take the first part of the question. And then Michele, you will take the second part of the question around the commercial and the TYK2.
And 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, and the ECB maybe 50 basis points away, we think we are going to be above 3% on average for 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 the 3% once we get to a stable level.
So I'll take the next question on the TYK2. So to start with, the guidance and the ambition we shared last year on Jyseleca was, per se, a positive business case, right? Remember the breakeven and then the profitability. Of course, this is part of the revisiting of what we are doing now to see how that goes.
But the part of the infrastructure we have built for Jyseleca in the core will also be instrumental to accelerate the start in oncology, which will be early in timing than the possible launch of the TYK2. 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 it later in decade, TYK2 or the lupus programs definitely will be able to leverage the infrastructure that we have built in the past years for Jyseleca.
[Operator Instructions]. Your next question comes from the line of Jason Gerberry from Bank of America Securities.
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 would be ultimately additional work needed to be done at some point to bridge a clinical product or process to commercial product 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?
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 xCellit platform.
We succeed at the moment consistently in delivering cells from the machine into the patients within 4 hours. We can do the quality release at the moment within 4 hours. In the morning, the cells come from the instrument; in the afternoon, the patient receives the cells in -- all included in the 7-day vein-to-vein process.
The second question? Yes, about the CTA versus the IND. No, not -- we'll be final at pivotal and we'll be able to submit with the pivotal process in the
[Operator Instructions]. Your next question comes from the line of Brian Balchin from Jefferies.
Just on BD again. Is the messaging still one additional product on the market by 2028? Or has the more challenging dynamic -- for just a lack of change to that thinking. i.e., could we expect a shift to more mid- to late-stage pipeline deals?
Yes. We are pushing very hard at the moment. We predict one additional product by 2028. That will be most likely one of our CAR-Ts. But we are very active in the oncology space, 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 to our internal work with the next CAR-Ts. Would we be able to bring 2 CAR-Ts by 2028 in different indications? As you know, we do the NHL with the 1 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 7 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 clinical work in the next 12, 24 months.
That's good, Brian?
[Operator Instructions]. 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 4. 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.