Good day and thank you for standing by. Welcome to the Galapagos Full Year 2022 Financial Results Call and Webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] Please note that today's conference is being recorded. I would now like to hand over to your first speaker Sofie Van Gijsel. Please, go ahead.

Thank you and welcome to the audio webcast of Galapagos full year 2022 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 downloads and replays 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 from the pipeline and our company and possible changes in the industry and competitive environment. Because these forward-looking statements involve risks and uncertainties, Galapagos' actual results may differ materially from the results expressed or implied in these statements. Today's speakers will be Paul Stoffels, CEO; and Bart Filius, COO and President. Paul will reflect on the operational highlights of the year and provide an update on our oncology and immunology franchise. 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 it over to Paul.

Good morning and good afternoon and welcome to our 2022 annual results reporting. So thank you for joining. It goes without saying that 2022 was an eventful year at Galapagos. We made significant progress with good sales performance and further rollout of the commercial organization. We entered a new therapeutic area with oncology, with the acquisition of Abound and CellPoint. We made significant progress in the regulatory review with JYSELECA on both on the testicular safety with the Manta CHMP positive opinion, as well as with the adoption of the PRAC regulation recommendations. In our Capital Markets Day, we shared with you our vision on 2028 and our new strategy focused on immunology, oncology and accelerating time to market for drugs. But we also disclosed to you the further optimization of our organization, with restructuring of 200 people out of the organization and a new organizational structure. And then, later in the year, we were able already to highlight the first good data of our ongoing trials with our CD19 in NHL and I'll also give you an update on the more recent data on CLL. Galapagos remains and position itself for strong growth in the future. We focused the pipeline on immunology and oncology, going in first-in-class to best-in-class, adding into that business development, new opportunities, external opportunities, and accelerated our entry in oncology with CAR-T and with new modalities. We now have the ability to do cell therapy and also on top of the small molecules we can do now biologicals in the modalities. We continue to build on a long-term Gilead collaboration, both on the R&D side, but also on BD with multiple interactions and exchange of information between the two companies of the future for our collaboration. At the end of 2022, we had a cash…

Thank you, Paul, and good morning everyone in the US. Good afternoon in Europe. Happy to be with you for the annual results and happy to also give you some color to the numbers that we've completed the year with. So let me start off with something that we're extremely proud of at Galapagos, which is the European performance of our commercial teams with Jyseleca. As you can see here, we are landing now the year at €88 million in terms of sales in Jyseleca in Europe. And as you remember, we've been able to increase our guidance twice during the year. And also this number is at the top end of that of that guidance range. And that within a year where there was the Article 20 review of the entire class, we are extremely proud with this achievement. We're treating now 18,000 patients across Europe and that number is increasing. Two noteworthy events in addition. First of all, we got the feedback from the EMA or the CHMP opinion on the MANTA and MANTA-RAy studies and how we can adjust the label for that and that opinion was positive, and we'll be able to in the course of this year update the label accordingly. So we're very pleased with that. That point is off the table for the European markets. And secondly, we've also seen the outcome of the Article 20 review process and it has confirmed that Jyseleca remains available for both biologic refractory and biologic naïve patients. And that any limitations are indicated for high-risk patients. So we're also pleased with that outcome for the entire class, because we believe the Class is a very strong, Class IV-patients with RA and UC. And I'll give a bit further detail on guidance in a few slides in…

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

Thank you. [Operator Instructions] We are now going to proceed with our first question. And the questions come from the line of Matthew Harrison from Morgan Stanley. Please ask your question. Your line is open.

Hi. This is Juan Zhang [ph] from Matthew's team. Thanks for taking our questions. So, I am curious about the potential efficacy bar of the CAR-T program. So, what would you see a potential response rate in a larger cohort and the potential duration of response that could be the current SOC? Thank you.

Well, I think from a -- what we can say based on the very small numbers, two times seven patients which we have today fast expanding in clinical that the initial response rate and complete response rates are very high. That probably has to do with a good quality of cells and a very good expansion of the cells. What we don't know is, the duration, because most of the time the failure is happening because of CD19 escape. The fact that we have very good complete response rates is predicting that we might expect a good overall durability, but the clinical trials have to show that. So I think so far so good. The clinical trial results midyear where we'll have the full dose finding as well as some of the expansion cohorts will give a good indication on duration. For now, we stay with the response rates we see in the small cohorts, what we have observed in NHL and CLL.

Just a follow-up with the CD19 program, can you talk about the case to use the CD19 in lupus? And are you looking at other autoimmune indications?

Yeah, there was a study which was done by a German group which was published and I think that's very well known in five patients where to many of our surprise, to many of us who are very surprised with a very positive outcome of that study with full responses in these people with very advanced lupus. And so, it's an exploratory study. And so we are going to try to repeat those results with our drug. There's a good chance that this type of medicine, this type of indication can be tackled with the CD19 CAR-T. But to be confirmed, so far we know of five patients with good results, five on five. Not our drug. And a drug developed by [indiscernible] a university in Germany. But it's an initial study exploring efficacy in lupus with CD19.

Okay. Thank you.

Thank you.

We are now going to proceed with our next question. The next question comes from the Phil Nadeau from Cowen. Please ask your question. Your line is open.

Good morning and thanks for taking my question and congrats on the progress last year. Sticking on the theme of the CD19 CAR-Ts, can you discuss what you think the regulatory requirements will be for CMC for point-of-care manufacturer? Is there any visibility on what the regulators will require in terms of the site visits, inspections or verification in order to get the CD19s approved? Thanks,

Yeah. It's very early of course to explain full CMC requirements. But what we see in the clinical trial today we are able to do a CD19 end-point of care fresh cells seven days vein-to-vein with all the necessary quality controls and quality release to make the release happen in the clinical trial environment. We are further automating and simplifying the quality control testing. We have a combination of a point-of-care system combined with a Digital Data System which records all of the quality control testing as well as the manufacturing parameters and under the clinical trial agreements with the government. Today we can do this in point of care. What is required is a GMP environment, because certain handlings have to be done in a GMP environment. We select at the moment the centers based on GMP capabilities and that works really well. They are at least in Europe they are expected by the authorities. So there I think we are safe. We are in a good position. In the U.S., most likely the strengthening of GMP capabilities in hospitals need to happen. That's not that a big step. It's doable. So from that perspective, I think, it's important that GMP capabilities are there. What we'll have to discuss with the regulators at the time of approval is the release criteria on potency on serology and also in our Phase III clinical trials on what will be required to release in point-of-care the testing. So we’re – this is all in the making. But currently in clinical trials we are able to do it in a very practical and pragmatic way with approval of the authorities.

That’s very helpful. Thanks for taking our question.

We are now going to proceed with our next question. And the question come from Peter Verdult from Citi. Please ask your question. Your line is open.

Yes, thanks. Good afternoon. Pete Verdult from Citi. Two questions, please. Paul just wondering if you've done any early the team – early post mortem on diversity and reasons for the failure. Anything you could share there? Any thoughts there would be helpful. And then secondly, just on BD. Would you like to – I mean we're approaching a year of your tenure. Would you like to do more? Or could you characterize the environment for doing BD? How conducive or not is it in terms of finding the lessons you're looking for? Thank you.

I missed on the first one. .

Do you want me to repeat the first question?

Yes. No that's too early. We went into a deep dive. It's very recent. We went into a deep dive on the data to be able to come to the conclusion. We are now looking at what happened in the study why negative, why the induction was negative but also the maintenance was positive. And more to follow on that. More work to be done on the details of the data before coming with the conclusion there. On the BD side, we have done and we are doing very extensive evaluations. First as you know, we have done Cellpoint and Abound already back in June and we brought them on board. They are now fully integrated. We are building on that capability of cell therapy to get to next-gen cell therapy potential, where we are evaluating multiple opportunities in the world. I think that's one. But on top of that we are evaluating multiple opportunities in other modalities in oncology as well as immunology. The team is very busy. The environment is good for us I think. But it's also how much can you take on with the company in a very short time with going through a restructuring as well as bring on-boarding significant new teams. I think it's going well. More to follow. The next year will be a year of on-boarding acquiring and on-boarding more assets.

Thank you.

We are now going to proceed with our next question. And the question comes from the line of Brian Abrahams from RBC Capital Markets. Please ask your question.

Hi, there. Thanks for taking my question. I was wondering if you could expand a little bit more upon like what we should be looking for from the NHL and CLL top line CD19 CAR-T data this year in terms of maybe a little bit more in terms of the dose levels, patient numbers and duration of follow-up. And then what's the latest on how you guys are thinking about a potential registrational path? Is there still an opportunity to accelerate development and perhaps a more niche indication? Or do you plan to go broad? Thanks.

Well, the two studies CLL and NHL are progressing in parallel. Each of them go with a study of 15 patients in the dose escalation, where we study a low medium and high dose. And then depending on the doses we choose, 30 patients per cohort in the expansion. So you could expect around in the range of 45 patients. If you have one in each of the different -- in the two spaces, that is what we could expect. The studies -- the first NHL study is ongoing from let's say, mid this year in -- sorry for last year 2022. So there we'll have up to one year response. The CLL started somewhat later. But at the same time, I think nine- to 12-month response time data you can see. So in total, between each of the two disease areas CLL NHL, we will present that type of top-level data mid this year. What we see with the use of the point of care, is that it allows physicians to treat very sick, very advanced patients with very short life expectancy. And that is an area where many of the centralized produced CAR-Ts, don't have an answer for because of the time the patient doesn't have any more, to receive their therapies. And so, we are going to discuss with the regulators to see what is the -- what can we -- what type of study, do we need to do in the really urgent need high medical need, whether there's no good solution anymore for patients. We see patients with one, two, three months of life expectancy still getting good outcome, with a seven days vein-to-vein therapy in the hospital. So that's where the first step, of our programs we'll focus on, is the extreme high medical need where we have a differentiated product, which we can bring with life-saving prospect. What is very particular in the CLL is that this ritux transformation is a disease today, which is not solved by any therapy. And that gives us an ability to look into, is that an indication we can pursue for accelerated review breakthrough, designation accelerated review with authorities to be discussed. We are not yet there, to submit the data. But that could be an opportunity, to go fast and bring something to patients, which is really transformational life-saving and doing a very high medical need. So, top line mid-next year, we'll have a good answer on all of the things I just lined up here in the discussion.

Thanks so much for the details there. So really helpful. Thanks

We are now going to proceed with our next question. And the questions come from the line of Jason Gerberry from Bank of America. Please ask your question.

Hi, good morning, good afternoon. This is Chi [ph] on for Jason. Thanks for taking the question. I guess first one just JYSELECA. I'm hoping, you can provide a bit more color on the guidance change on peak sales. Earlier in the call you mentioned guidance make €50 million peak sales for Crohn's and do guidance factor in impact from Article 20. Could you help us understand your assumptions on the contribution of parts among these three indications? And then second on '3667. Arguably TYK2 your landscape has evolved quite a bit over the past six to 12 months, following the deucravacitinib [ph] could you talk about the potential point of differentiation with 3667. Does there have any distinctive molecular features, say selectivity, potency or PK that you think could stand at relative to competitive programs? Thanks.

Yes. So Michele will take the first question on JYSELECA, and then Daniele you can maybe chime in on the question on the TYK2.

Yeah, sure. So on the JYSELECA model, I think first the changes from peak sales €500 million to €400 million and that's a difference of €100 million. And then the contribution margin at peak is 50%. So that's €100 million sales transfers into €50 million contribution. I think that's the €50 million that Bart mentioned before, so to give the context of the €50 million. Then, of course, we move from €500 million to €400 million. The moving parts are -- I mean the big blocks are Crohn's going out, AxSpA coming in and I would say some marginal adjustments because of course of the impact of Article 20. So let me give some color on these three components. Crohn's going out. We did not give specific details on the composition of the €500 million before. But as a reference, we also shared that we see the market of €3 billion for array, €2 billion for Crohn's, and €1 billion for UC. So Crohn's basically accounting from one-third of that market. So that gives us a sense of direction of how much Crohn's was part of the €500 million. So that's what we lose by not approving in that indication. On top we come with the AxSpA. In Europe, AxSpA can forecast at the time of launch will be a market worth about €1 billion. And then there also we remain with the previously mentioned 8% to 12% market share to capture in that market. So that's a positive that comes in. And, well, the last part is of course Article 20 that came in -- and it's now the label about to be approved. The outcome is ultimately a positive outcome, because it doesn't bring the limitations that the FDA for example brought in the US. But still give…

Great. Thanks.

Sure. Thank you.

We are now going to proceed with our next question. And the questions come from the line of Rosie Turner from Jefferies. Please ask your question.

Hi. Good afternoon. Thank you so much for taking my questions. Maybe just following up on Pete's question around business development. Can we just clarify, are you still looking at, kind of, very much earlier stage assets? Or is there a potential that it could be something, kind of, mid-stage? And then thinking about your Richter transformation patients. Was it a conscious decision for targeting that population within these, kind of, two early-stage trials? And are you aware of anybody else who is I mean I appreciate there's nothing currently on the market for these patients. And are you aware of anyone else that is looking at this area? Thank you.

Yes, Rosie. Let me first take the question on BD, and then Paul, you'll take the question on the Richter patients. So I think it's unchanged compared to focus what expressed before. So we're very much interested to do either licensing or M&A in a stage of development where there's still value creation to be made by Galapagos. So you not find us very quickly in a major competitive bidding process for a late-stage asset at high values. We think we should be more on the early clinical. I would not rule out mid-stage as you say. So I think Phase 2 is definitely part of the equation. Ultimately what also matters here is time to market and not just the actual precise stage of the molecule. We do also want to make sure that we have some assets in our pipeline that still can get to approval stage within the decade like is the case for our existing pipeline. So maybe that helps. So all-in-all still early stage Phase 1, Phase 2, definitely still be on the agenda. We're also looking at preclinical opportunities because in some areas that's definitely also interesting. And lastly and finally, also the European, let's say, assets for -- let's say leveraging our commercial infrastructure are very much also part of the focus of our BD teams.

Yes. On the Richter transformation what we observe is that because of the point of care and the availability of a 7-day vein-to-vein at the moment in the studies people are brought to the hospitals where we are able to treat those. So that is a first an observation. If you ask would we only target Richter’s? Most likely not. But it would be the aggressive form of CLL whatever that definition embraces as well as Richter transformation to have a -- those people who have a short life expectancy with very aggressive disease who can benefit from the point of care advantage of having a 7-day vein-to-vein in the hospital available. Currently, we are not aware of anybody focusing on Richter maybe with our data some other companies would start doing that. But I think the very important thing is the 7-day vein-to-vein the very short time access for very advanced people, which is difficult to match with centralized production. That is where we – good product combined with the decentralized and seven days vein-to-vein fresh – using fresh cells is probably the combination which gives the benefit to these patients.

Thank you.

[Operator Instructions] We are now going to proceed with our next question. The questions come from the line of Dane Leone from Raymond James. Please ask your question.

Hi, thank you for taking the questions. And congrats on all the progress. I just want to follow up on a JAK2 question. I know there's been some questions earlier in the call but let me pose the question this way. Clearly, there's a growing investment in the space as a drug class that might be a better oral solution in certain autoimmune inflammatory disorders. And what was able to be achieved with JAK inhibitor class? Later this year we'll get proof of concept in Crohn's and ulcerative colitis from the deucravacitinib effort over at Bristol. And clearly Takeda is going to put a lot of investment behind the Nimbus asset that they've recently acquired. So the question for your team is currently we're waiting on the start of the dermatomyositis study. But there really has not been a lot of messaging on how that program would expand around that. Is your view that one, it needs to be more of a measured approach to developing the Galapagos TYK2 inhibitor maybe given the experience with filgotinib? Or is there going to be an approach where you're looking to go into indications maybe that the other two players are not going to be pushing into that might be a lower investment from both money and time to get to market? Any insight there would be greatly appreciated. Thank you. Daniele D’Ambrosio: Yes, maybe I can take this question again. So as you said, there will be inflection points and information that will come during the course of the year. So we'll obviously look at that very carefully. But at this point, given the data we have in our hands and having seen the data from the competitors so far, we believe the best scenario for our molecule is the indication we are currently pursuing. That doesn't mean that we are not going to reevaluate new data to potential other opportunities. But we really see based on what we understand of the below in our hands and the competitors that the two indications are the very good benefit risk profile, very high and need. And I think again, a good fit with the mechanism of action that we see with our molecule and the preferential inhibition of [indiscernible] versus the site looking [indiscernible] cytokine, which we've seen differently inhibited by the other molecules. So, we really feel this is the best room for this compound at this point in time. That might change our course with new data cue, but this is the current situation.

So, maybe if I can add one or two words on this one beyond the clinical choices. I would say in needing that we're carefully selecting now the indication that we go after for the reasons that Daniel just described. We believe going now, for example, after psoriasis five years after deucra given the stage that we are in today, is not the most logical thing to do. But we are very keen obviously to first see the data in both dermatomyositis and lupus to understand exactly what we have in hand before we make final choices and further choices in terms of development. So, just to say, we're very keen and interested in this field. We like the asset that we have a lot. We welcome the fact that the big players are also stepping in to this field. And we'll make sure that we develop this wisely and make our choices over time. I hope that helps.

We are now going to proceed with our next question. The questions come from the line of Sebastiaan van Schoot from Kempen. Please ask your question.

Hi there. This is Suzanne on for Sebastian. Thanks for taking our questions. First, regarding the mid-2023 day assets that you will present for NHL and CLL, can you clarify what number of patients we should be expecting to be included in those data cuts? Should we expect that all those expansion patients are included next to the dose escalation even though there will be shorter follow-up for dose?

Well, the final data of the dose finding will be presented there. And then, whatever data we have on the dose expansion will be included on the safety side. We hope to be able to have already significant durability data from the dose findings. Mid in the year at the point where we had that, towards the end of the year we'll have more data on the longitudinal follow-up of the expansion cohorts.

Got it, got it. And just to double check, should we also be expecting an announcement on the recommended Phase II dose for those two studies in between now and the mid-2023 data presentation?

Not between now and the mid-'23 data presentation, that will be part of the regulatory discussions happening later next year.

Got it. And then, maybe a final question regarding your breakeven point being moved out to 2025 versus previously. Just to understand, given Crohn's was not expected to be a large contributor to 2024 per se. Can you elaborate on the dynamics I'd like you to adjust your forecast? And if it's more relating to lower sales expectations or higher sales and marketing costs?

No, Suzanne. No, it's actually related to the fact that in 2024 we were anticipating also a milestone on Crohn's approval that we're not going to have. And we're also -- as part of the 2021 agreement with Gilead, we're also paying slightly higher royalty to them, now that the total market potential is a bit lower. So those two effects would basically dip us just below the breakeven. And therefore, we need to extend it to 2025. It's not big numbers. I would say, up to maximum €50 million negative for 2024. So these are, let's say, small adjustments. But in full transparency we wanted to indicate that to the Street. And by the way, this does not affect the overall cash burn perspective that I laid out back in November at the R&D Day in New York, because we do believe that our actual cash spend on the rest of the business, as we've now indicated, the reduction of more than €100 million for this year can definitely offset that extension of the breakeven point. So, overall, cash profile for Galapagos is unchanged. Diminishing cash burn for the short and medium term, up to a level where ultimately JYSELECA could contribute roughly €200 million a year in terms of cash. And that number, as I indicated earlier, is a bit lower than what we had anticipated when Crohn's was still around. I hope that clarifies.

Got it, got it. Thank you, very much.

We have no further questions at this time. I will now hand the conference back to Sofie Gijsel for closing remarks. Hello, Sofie, over to you.

Thank you very much, operator. So that concludes today's earnings call. Please feel free to reach out to the IR team if you still have questions. Our next financial results call will be our Q1 2023 results on May 5. 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 your lines. Thank you.