Galapagos NV

welcome all to the audio webcast of Galapagos' Q1 2024 results. I'm Sofie van Heersel, 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 companies, 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 Ted Houston, CFO and COO. Paul will reflect on the first quarter of 2024 and present a corporate update. Ted will provide an operational update and go over the financial results. He will also discuss the outlook for 2024 and present concluding remarks. 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 Ted, joined by Jeevan Shetty, head of development oncology. And with that, I'll now turn it over to Paul.

And thank you all for joining for today's webcast. I would like to take a minute to start with our foundation, our vision and mission, which we presented shortly after I joined Galapagos in 2022, and which informs all we do. We aim to transform patient outcomes through life-changing science and innovation for more years of life and quality of life, and our vision is to eventually reach patients around the world. To that aim, We accelerate transformational innovation through the pursuit of groundbreaking science and collaborations with industry and scientific partners. Since I joined a little over two years ago, we went through a very important company transformation. And with the recent transfer of Giseleca business to Alpha Sigma, we have transformed Galapagos into a pure play biotech with a revitalized pipeline and put in place the tools we need to meet our future growth ambitions. Today, we are focused on driving value creation in our key therapeutic areas of immunology and oncology, where significant unmet medical needs remain for patients. Our strategy is to spearhead our efforts with indications that have breakthrough designation potential in oncology and in immunology. And we are building a broad R&D pipeline of potential best-in-class cell therapies and small molecule drugs. We put in place strong leadership with the track record of delivering transformative drugs to patients around the globe. We take a collaborative approach combining internal and external innovation. And our strategy is supported by a very strong cash position of 3.6 billion euros as of the 31st of March 2024. I'm pleased to present our new management team to you. We assembled a team of experienced world-class leaders across our therapeutic areas and platforms with top talent from companies such as J&J, Kite, Milteni, JSK, and BMS. Combined, the team has brought well over 30 drugs to market. We strongly believe that we have the capabilities in place to drive value creation from here. We are building our differentiated platform technologies to bring to bring medicines to patients across the globe, working on small molecules, cell therapy, and biologics. Thanks to the acquisition of Abound and CellPoint in 2022, we added cell therapy and biologics to our capabilities. In cell therapy, we have an innovative, scalable, decentralized manufacturing platform that enables us to deliver fresh CAR T therapies close to patients, and we have a unique R&D engine to discover and develop armed multi-targeting CAR-Ts for hematology and solid tumors. We have a strong legacy of small molecule research and development in immunology, and we have now expanded our small molecule efforts to precision oncology. The teams are progressing our discovery and development efforts across multiple modalities, focusing on finding groundbreaking solutions for high medical needs with the aim to accelerate time to patients. Here you see our pipeline in our two therapeutic areas, oncology and immunology. We aim to deliver best-in-class therapeutics. In oncology, we are progressing our Phase I-II CAR-T programs, 5-1-0-1 in NHL and 5-2-0-1 in CLL and Richter's transformation, as well as our BCMA-directed multiple myeloma program with 5-3-0-1. In our early research, we have over 10 discovery programs across CAR T and small molecules in both heme and solid tumors. In immunology, we are progressing our two phase two studies with 3667 in lupus and dermatomyositis. And we have over five discovery programs across various inflammatory and autoimmune indications. As we continue to broaden our pipeline, We continuously look for differentiated technologies that enable us to reach more patients with high needs in an innovative way. Decentralized CAR-T cell therapy is a key example of that. CAR-T is one of the most remarkable advances in cancer therapy in the last several decades. Nonetheless, we see today that only 10-30% of eligible patients receive this therapy. Access is restricted for a number of reasons that go hand in hand with the fact that these products are produced in large and costly GMP facilities in a centralized way. Centralized manufacturing faces significant logistics challenges, including chiro-preservation of cells to allow for shipment. We address the limitation of existing CAR-T therapies with our decentralized manufacturing model. We have an exclusive global license with Lonza for the Cocoon manufacturing platform. for the decentralized delivery of CAR T cells in hematological tumors. We are able to deliver fresh FIT cells with a median seven-day vein-to-vein time. This allows for greater physician oversight and for production model near the patient that is globally scalable. As mentioned, currently we have three clinical trials running on the cocoon with very encouraging efficacy and safety results in critically ill patients with NHL, CLL, and Richter's Transformation. We're also actively rolling out a decentralized CAR-T network, both in Europe and the U.S. In the U.S., we collaborate with Landmark Bio for the Boston area and with Thermo Fisher for the Bay Area. And we are in discussions with other parties for additional centers. In Europe, we plan to add additional sites to the five that we currently have up and running in three different countries. We expanded our operations in Pittsburgh, Pennsylvania. As you remember, this is the site which we added with the acquisition of Abound Bio in 2022. And we opened an office in Princeton, New Jersey, where we are adding key capabilities in strategy, regulatory operations, and quality. I would like to highlight our extensive network to rebuild I would like to highlight our extensive work to rebuild and expand our earlier stage pipeline, where we're making important progress throughout our therapeutic areas in both small molecules and cell therapy. We have over 15 programs in discovery across oncology and immunology, and we expect to deliver the first preclinical candidates this year and start first in human studies in 2025. I would now like to hand it over to Tad for the financial comments. and operational updates.

Thank you, Paul, and thanks, everyone, for joining today. Let's take a look at the financial results for the first quarter. As a reminder, we transferred the Giseleca business to Alpha Sigma, and the transaction closed on January 31st of this year. As a result, the Giseleca results moved to discontinued operations. For our continued operations, revenue remained flat year over year, and mainly consists of the linear recognition of the platform for the Gilead collaboration. We see an increase in R&D costs as compared to last year, which is mainly driven by our investments in oncology, both in CAR T and small molecules. We record a net profit driven by fair valued adjustments, foreign exchange, as well as 25 million euros in interest income. We also reported net profit from discontinued operations of €67 million, mainly driven by the one-time gain of €53 million for the Giseleca transaction with Alpha Sigma. Now over to our 2024 guidance. You may have seen that we report an operational cash burn of €125 million for the first quarter of 2024. This is on the higher end due to the phased transition of services for Jaisalica to Alpha Sigma, as announced last year, as well as timing of interest income and tax credits. We expect that our operational cash burn will continue to improve in future quarters, and we therefore reconfirm our full-year cash burn guidance of 280 to 320 million euro. Our cash balance at Q1 2024 amounted at 3.6 billion euro. With streamlined operations and a strong balance sheet, we are confident that we have the organizational setup and firepower to execute on R&D and collaboration opportunities. Now turning to our outlook for 2024, we anticipate important regulatory progress with our CAR T trials in the United States. Mid this year, we plan to submit the IND for our NHL trial, building on the tech transfer to our first US site, Landmark Bio. In the second half of the year, we aim to submit an additional IND for 5201 in CLL and Richter's transformation. We will share further data on the safety, efficacy, and durability of our ongoing CAR T programs. We hope that this will confirm the data with our decentralized CAR-T platform that we have observed thus far. We are preparing to expand our Atalanta trial in NHL to the U.S. to initiate the Phase II Euplasia trial and CLL and Richter's transformation in Europe, as well as expand our Phase I to Papillo trial in Europe. Operationally, we are working to add additional sites for our decentralized CAR-T manufacturing network both in the U.S. and in Europe. We're also exploring additional partnerships for our CAR-T network across the globe. We also aim to execute on additional licensing agreements and acquisitions, as well as research collaborations. Our business development efforts serve as an overarching purpose of accelerating breakthrough solutions to patients in need. Let me conclude by coming back to the strong fundamentals that we have put in place to build a global innovative biotech company and the clear path that we have towards value creation. We are progressing our early stage pipeline, building on our renewed discovery portfolio based on best-in-class targets towards best-in-class medicines. While we push forward internal programs, we are also very active in business development discussions to broaden our portfolio. We continue to execute on our scientific progress in our key therapeutic areas of immunology and oncology. We invested and we continue to invest in strengthening the team in key positions globally. We benefit from a very strong balance sheet, and we commit to staying disciplined in our use of cash to focus our investments to maximize value. And we want to thank our investors for the continued support as we continue to deliver on our strategy to generate sustainable long-term value for shareholders.

Thank you. That concludes today's presentation portion of the conference call. I would now like to ask the operators to hand it over for Q&A.

Thank you, dear participants. As a reminder, if you wish to ask a question over the phone, please press star 11 on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star 11 again. To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question. Please stand by while we compile the Q&A roster.

This will take a few moments. And now we're going to take our first question.

It comes from from UBS. Your line is open. Please ask your question.

Thank you very much. Thank you for taking my question. Just one, please. As you mentioned, the tech transfer is due in the US is due in H1 this year. So I was just wondering, do you think this is the gating factor for a rapid, let's say, a rapid increase in progression of enrollment for the trial. And once you have all those centers set up, do you think we can expect to see a rapid enrollment increase and a potentially very quick progression to pivotal, let's say, those expansion phase? Or do you think this is more of a, let's say, strategic allocation of resources and the capital, please? Thank you very much.

Thank you for the question. I can certainly start. Clearly, the gated step with regard to the tech transfer, this goes hand in hand with the IND for NHL and CLL. And we plan for that from mid 2024. And in quick succession to that will be the IND for CLL. With regard to the tech transfers, clearly the tech transfers are important to the point that you make regarding the patient recruitment. And these steps go hand in hand with regard to the recruitment, which is already ongoing in our clinical program in Europe, but for it to be initiated and accelerate in the US. With regard to the capital allocation,

Yeah, we have qualified landmark bio just recently, and that site is ready. So that puts us well positioned for the IND filing mid-year. We're also now in the process of getting Thermo Fisher also for the Bay Area in the second half, and we're going to be adding additional sites. So we're very focused on expanding the number of sites both in U.S. and Europe to help us build out our platform to support all of our clinical studies.

Thank you very much.

Thank you. Now we're going to take our next question. Just give us a moment. The next question comes from . Your line is open. Please ask your question.

Good morning. Thanks for taking our question and congrats on the progress. Just one from us. In terms of 5101, 5201, and 5301, when could we see We understand you're continuing to enroll patients, but any specific plans to present updated results from those programs? Thanks.

Thank you for your question. With regard to the first two studies, we will be presenting data in upcoming hematology conferences this year, a combination of new data and also updated durability data. With regard to your reference to the multiple myeloma study, the program has just opened very recently and just started recruitment, so a little bit early with regard to that, but there will be a continuous stream of data over the 2024 and beyond.

Perfect. Thank you.

Thank you.

Now we're going to take our next question.

And the next question comes from Brian Abrahams from RBC Capital Markets. Your line is open. Please ask your question.

Hi, everyone. This is Nevin on for Brian. Thank you for taking our question. Just to follow up on that question, so how are you thinking about advancing 5301 in multiple myeloma, especially in light of some of the other competitor products that are moving up in the treatment paradigm and some of the other bispecifics that are expected to launch in the space as well? And then how much additional value would the decentralized manufacturing process offer to multiple myeloma treatment versus either NHL or CLL? Thank you.

Well, the multiple myeloma program is in phase one dose finding. We are learning about the seven-day vein to vein process, which we can also apply here and look about what type of efficacy and durability we can generate with that. Pending that, we'll decide going forward with additional studies, but that is ongoing as we speak. uh in uh in in europe and hopefully uh we'll have more data towards the end of the year or in beginning of course of next year uh on on concluding we we have seen in both with the 5101 and 5201 is that the fresh cells provide significant good efficacy but also safety And we do the learning exercise from the 5301 here to see whether the fresh cells approach and close to patients can generate a benefit for patients, both safety, efficacy, but also durability. And then we'll decide next steps.

Thank you.

Thank you. Now we're going to take our next question. Just give us a moment.

And the next question comes to the line of Judah from Morgan Stanley. Your line is open. Please ask a question.

Yeah. Hi. Can you hear me okay? Yes. Thanks for taking the question. I just wanted to get your thoughts on and maybe some commentary coming out of other CAR T players. Gilead has discussed expanding toward the community setting given capacity constraints. And Bristol has expanded its partnership with Solaris and their cell shuttle system. So just curious if you see these as confirming the need for a point-of-care CAR-T, and does this invite incremental competition? And if so, do you feel that you're in the lead with the cocoon system? Thank you.

Well, I think with the cocoon system, we can provide several benefits. It's really scalable on a global basis where you can go every corner of the world, but also every corner of Europe and the US is possible. Then second, there is still a very high medical need because of access at the moment in many parts of the US as well as in Europe. And I think we can provide access with a really scalable model to patients. I think that is a clear... complementary platform which can be used to provide CAR T as the indications expand and also the applications expand like solid tumors as you see the first results emerging from that the need for capacity is going to be even bigger going forward and that's where we think we are the first with a solid system to go decentralized close to the patient we bring benefit on seven days vein to vein, and can treat people with very high medical needs and short life expectancy, which we have seen in our current trials, and hopefully combine that with capacity. but also combine it with the benefit of the safety and the efficacy what we have seen in already so far to be confirmed in phase two studies. But we see a lot of benefits in the platform to be able to be available, we give good results, solving short life expectancy challenges, and the broadening need for capacity growing NHL in, sorry, in hematoma and solid tumors.

And just to add to that, the platforms that you've shared, i.e. Solaris with BMS and the others, really we are quite differentiated from that by virtue of the fact that we're delivering fresh product, fresh cells in, fresh product out. And we believe that the translational data that we are publishing and continue to publish show clear differentiation and will continue to do so as the years go on and we continue to share data. Great. Thank you.

Thank you. Now we're going to take our next question.

And the question comes from the line of Jason Garbery from Bank of America. Your line is open. Please ask your question.

Hey, this is Chi. I'm for Jason. Thanks for taking questions, maybe two on INI for us. I'm curious, can you talk about your research and development efforts for CAR-T in the broader INI landscape outside of lupus? And if the effort is still in early stage, when do you think investors can learn more about your efforts there? And my second question is on 3667. Curious if you have any thoughts of exploring that agents and additional indications. For instance, FieldGo previously had some interesting phase two data in uveitis. And Royvan recently provided some phase 2A top line data with that JAK1 TIK2 inhibitor. So curious, do you think the mechanism of 3667 makes sense? Or whether the market opportunity for uveitis makes sense for you to explore this agent in uveitis? Thank you.

Well, let me start with the TIC2 program, your second part of the question. We are currently validating and do the proof of concept in two indications, dermatomyositis and lupus. We are strong believers that... that the mechanism of action with the complete inhibition of type 1 interferon signaling and not inhibiting IL-10 signaling, we think that we have a product which has a good chance of working there in this type of diseases. And for that, so we'll wait for, we'll first deliver results on dermatomyositis and lupus before expanding into other indications. There might be a lot of other applications, but we have decided to first do the proof of concept or determine efficacy in those two indications before going further into others. With regard to autoimmune and CAR-T, we absolutely are continuing to look at new technologies to step away from from the integration of viral vectors into the genetic material. And there we have internal efforts ongoing as well as external collaboration we explore on new mechanisms to develop CAR-Ts without integrating viral vector systems. So that's ongoing and we'll keep you updated. whether at the moment we have either internal results or a BDE opportunity which we pick up. Thank you.

Got it. Thank you.

Thank you.

Now we're going to take our next question. Just give us a moment.

And the next question comes from the line of Jacob Michael from KBC Security. If your line is open, please ask a question.

Hi there, and thanks for taking my question. I'm just curious, when you refer to BD opportunities, I just would like to get a better idea of your approach here. Do you have a preference for licensing compared to M&A, or are both equally on the table? And what are the factors that would influence your choice either way?

I think both licensing and M&A acquisitions are on the table. We looked to see where we can find opportunities where they're in immunology or oncology, clearly assets that are addressing high medical need where we really have a high bar, but then also looking even at late preclinical to early clinical proof of concept types of things where we think that we can add substantial value. So we look at all. We also have done some research collaborations early stage too to broaden our portfolio. I think one thing to point out here today too is, you know, we're sharing a bit more about the number of programs that we have in internal research. And, you know, Paul mentioned that we have 10 in oncology and another five in immunology. We want to continue to complement that and to build that out both in terms of CAR T and and small molecules. So those are really, you know, we see tremendous opportunity, obviously given our firepower and where we sit today. But we also have a fantastic team to assess these BD opportunities and to help bring in the best things that fit for Galapagos.

Okay. Thank you very much. Thank you.

Thank you. Now we're going to take our next question. Just give us a moment. And the next question comes to the line of Sean McCutcheon from Raymond James. Your line is open. Please ask your question.

Hi, guys. Thanks for taking the question. Maybe to build on the last question. So for the next wave of potential assets within the portfolio, interesting to deal with Bridgene, maybe using that as a backdrop for more macro commentary on the development strategy. They have targeted small molecules and covalent protext What is your view as you build out the portfolio on the state of play in targeted oncology? You know, there's a lot of Me Too assets for validated targets, but where do you think Galapagos could fit in? And then maybe what's your view on the graders and the optionality that that might bring in oncology and immunology? And is that an MOA that you're interested in pursuing? Thanks.

Yeah. Yeah, we did a collaboration with Brygene focusing on precision medicine using new targets, not new to existing targets, which are validated, but at the same time offer the opportunity to be differentiated with next-gen therapy, with next-gen molecules. And that's where the combination of... of real medical need where there is no option and we find a way to, with combining the diagnostic tools with having precision medicine, we think that we can, with our platform and with our team which we assemble, we can make differentiated medicines against the number of these targets. We are accessing the platforms like Brigene. You have also seen that we did a strategic investment in Frontier, which has a very broad KRAS portfolio on multiple opportunities and for both for products, but also collaboration with the platform. So that's the approach we do where every time addressing a disease where there is no solution allowing to go for good clinical efficacy leading to breakthrough designation and accelerated approval because of the high medical need. So we basically process to being able to bring this type of medicines as I just quoted. I hope we'll plan definitely to have a more extensive review on our early stage portfolio in one of the coming quarters. We'll see when we do that, when we have the first results to present.

Thank you.

Thank you. Dear participants, as a reminder, if you wish to ask a question over the phone, please press star 11 on your telephone keypad and wait for your name to be announced. To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question. Thank you. Now we're going to take our next question, and it comes to the line of Sebastian van der Schot from VLK. Your line is open. Please ask your question.

Hey, guys. Thank you for taking the question. In the past, you have mentioned that you see the CLL program as the most likeable program to get a fast proof of concept and get to the market. you provide your vision on the current progress of the program and the likelihood of a physical study after the update later this year and maybe you can also put the results in context of bms's recent approval in cl thank you thank you very much for the question first of all i'll speak to the program and then secondly to the data from bristol marsquib

With regard to our high-risk CLL and Richter transformation studies, the expansion part of the study is to be initiated imminently. We've had very meaningful conversations with the authorities. EMA in particular with regard to our regulatory path forward and we've got a clear path forward with regard to this and the aforementioned IND also permits us to have the discussions with the regulators. We want to align with the regulators, the US authorities, the FDA and really work out a program of one set of globally appropriate studies But we have very clear direction in terms of what we wish to do in both the high-risk CLL and the Richter's transformation population. We believe we'll be able to have a very broad access and really help a significant number of patients in the process in this area, particularly Richter's transformation, which has a very significant unmet need. To the second part of the discussion regarding the Bristol data with Bianzi, we of course welcome new therapies for patients in this significantly underserved disease. But there are some important observations. What they have presented is a single arm study with no patients suffering from Richter's transformation. In addition, the patients waited for a median vein-to-vein time of 36 days. Furthermore, the efficacy of less than 20% really does leave us an opportunity to improve this and really fundamentally impact on benefit to patients. And so with that in mind, we are in a very strong position to know what data is out there, and clearly with our unique platform, seven-day vein-to-vein, fresh-to-fresh, without any cryopreservation, and the data that you have already seen, as well as the additional translational data, we feel very confident that we're going to be able to contribute significantly to patients. Great, thank you.

Thank you. Now we're going to take our last question for today. And the question comes from Shan Hama from Jefferies. Your line is open. Please ask your question.

Hi, thank you for taking my question. Just also on business development, should we expect deals as a string of pearls throughout the year, or is it preferable to have the outright acquisition of one company with a number of de-risk late-stage assets. Thank you.

Yeah, we continue to follow our plans to both assess string of pearls, and we were in discussions with a number of different companies to look at earlier late preclinical, early clinical assets, but we also assess larger transformations to try to you know, have something that's near term to the market as well. And we continue to evaluate a number of larger potential BD opportunities as well.

Thank you.

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 is our H1 2024 call on August 2nd. Thank you all for participating and have a great rest of your day.