Galapagos - Q1 2024

Transcript

Operator (participant)

Thank you for standing by. Welcome to the Galapagos first quarter 2024 financial results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question-and-answer session. To ask a question during the session, you need to press star one-one on your telephone keypad. You will then hear an automated message advising your hand is raised. To withdraw a question, please press star one-one again. To ensure everyone has opportunity to ask a question today, please limit yourself just to one question. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our speaker today, Sofie Van Gijsel. Please go ahead.

Sofie Van Gijsel (Head of Investor Relations)

Thank you, operator, and welcome all to the audio webcast of Galapagos's Q1 2024 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's actual results may differ materially from the results expressed or implied in these statements. Today's speakers will be Paul Stoffels, CEO, and Thad Huston, CFO and COO. Paul will reflect on the first quarter of 2024 and present a corporate update.

Thad 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 Thad, joined by Jeevan Shetty, Head of Development Oncology. With that, I'll now turn it over to Paul.

Paul Stoffels (CEO)

Thank you all for joining for today's webcast. I would like, 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 Jyseleca business to Alfasigma, 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. 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 a 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 EUR 3.6 billion 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, Miltenyi, GSK, 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 AboundBio 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 unmet 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, 5101 in NHL and 5201 in CLL and transformation, as well as our BCMA-directed multiple myeloma program with 5301. 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 II 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 unmet 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 cryopreservation 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 are also actively rolling out our 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 AboundBio in 2022. 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 work to rebuild and expand our early 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 Thad for the financial and operational update.

Thad Huston (CFO and COO)

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 Jyseleca business to Alfasigma, and the transaction closed on January 31st of this year. As a result, the Jyseleca 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 in oncology, both in CAR-T and small molecules. We record a net profit driven by fair value adjustments, foreign exchange, as well as EUR 25 million in interest income.

We also reported net profit from discontinued operations of EUR 67 million, mainly driven by the one-time gain of EUR 53 million for the Jyseleca transaction with Alfasigma. Now over to our 2024 guidance. You may have seen that we report an operational cash burn of EUR 125 million for the first quarter of 2024. This is on the higher end due to the phased transition of services for Jyseleca to Alfasigma, 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 EUR 280 million-EUR 320 million. Our cash balance at Q1 2024 amounted to EUR 3.6 billion.

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 U.S. 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 Euplagia trial in CLL and Richter's transformation in Europe, as well as expand our phase I/II Papillon 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 are 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. 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.

Sofie Van Gijsel (Head of Investor Relations)

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

Operator (participant)

Thank you, dear participants. As a reminder, if you wish to ask a question over the phone, please press star one-one on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star one-one again. To ensure everyone has the opportunity to ask a question today, please limit yourself just to one question. Please stand by. We'll compile the Q&A roster. This will take a few moments. Now we're going to take our first question. It comes to the line of Xian Deng from UBS. Your line is open. Please ask your question.

Xian Deng (European Pharma Equity Research Analyst)

Thank you very much. Thank you for taking my question. Just one, please. As you mentioned, the tech transfer is due, sorry, in the U.S. 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 set, 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.

Jeevan Shetty (Head of Development Oncology)

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 for 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 that which is already ongoing in our clinical program in Europe, but for it to be initiated and accelerate in the U.S. With regard to the capital allocation?

Thad Huston (CFO and COO)

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 the U.S. and Europe, to help us build out our platform to support all of our clinical studies.

Xian Deng (European Pharma Equity Research Analyst)

Thank you very much.

Operator (participant)

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

Philip Nadeau (Senior Biotechnology and Healthcare Equity Analyst)

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 the next data? We understand you're continuing to enroll patients, but any specific plans to present updated results from those programs? Thanks.

Jeevan Shetty (Head of Development Oncology)

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 2024 and beyond.

Philip Nadeau (Senior Biotechnology and Healthcare Equity Analyst)

Perfect. Thank you.

Operator (participant)

Thank you. Now we're going to take our next question. The next question comes the line of Brian Abrahams from RBC Capital Markets. Your line is open. Please ask your question.

Nevin Varghese (Assistant VP and Biotechnology Equity Research Analyst)

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, you know, bispecific 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, you know, NHL or CLL? Thank you.

Paul Stoffels (CEO)

Well, the multiple myeloma program is in phase I 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 as that is ongoing as we speak, in Europe, and hopefully, we'll have more data towards the end of the year or in beginning of course of next year, on concluding. We have seen in both with the 5101 and 5201, is that the fresh cells provide significant good efficacy, but also safety.

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.

Nevin Varghese (Assistant VP and Biotechnology Equity Research Analyst)

Thank you.

Operator (participant)

Thank you. Now we're going to take our next question. Just give us a moment. And the next question comes the line of Judah Frommer from Morgan Stanley. Your line is open. Please ask your question.

Judah Frommer (Senior Equity Research Analyst)

Yeah. Hi, can you hear me okay?

Paul Stoffels (CEO)

Yes.

Judah Frommer (Senior Equity Research Analyst)

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 Cellares 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.

Paul Stoffels (CEO)

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 U.S. is possible. Then second, there is still a very high unmet medical need because of access at the moment in many parts of the U.S. 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 II studies. But we see a lot of benefits in the platform to be able to be available, we give good results, short life expectancy challenges, and the broadening need for capacity growing, NHL and in hematology and solid tumors.

Jeevan Shetty (Head of Development Oncology)

And just to add to that, the platforms that you've shared, i.e., Cell Shuttle 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.

Judah Frommer (Senior Equity Research Analyst)

Great. Thank you.

Operator (participant)

Thank you. Now we're going to take our next question. The question comes through the line of Jason Gerberry from Bank of America. Your line is open, please ask your question.

Chi Fong (VP and Equity Research Analyst)

Hey, this is Chi on for Jason. Thanks for taking the questions. Maybe two on IND for us. I'm curious, can you talk about your research and development efforts for CAR-T in the broader IND landscape outside of lupus, and if the effort is still in early stage, when do you think investor can learn a bit more about your efforts there? And my second question is on 3667. Curious if you have any thoughts of exploring that agent in additional indications. For instance, filgotinib previously had some interesting phase II data in uveitis, and Roivant recently provided some phase II top-line data with their JAK1/TYK2 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.

Paul Stoffels (CEO)

Well, let me start with the, with the TYK2 program, your second part of the question. We are currently validating and do the proof of concept in the two indications, dermatomyositis and lupus. We are strong believers that that the mechanism of action with the complete inhibition of type one 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 our 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 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 BD opportunity, which we pick up. Mm-hmm. Thank you.

Chi Fong (VP and Equity Research Analyst)

Got it. Thank you.

Operator (participant)

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

Jacob Mekhael (Equity Research Analyst)

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?

Thad Huston (CFO and COO)

I think both licensing and M&A acquisitions are on the table. We looked to see where we can find, you know, 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, you know, 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 wanna continue to complement that and to build that out, both in terms of CAR-T and small molecules. So those are really... Yeah, 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 help bring in the best things that fit for Galapagos.

Jacob Mekhael (Equity Research Analyst)

Okay, thank you very much.

Thad Huston (CFO and COO)

Thank you.

Operator (participant)

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

Sean McCutcheon (Director of Biotechnology Equity Research)

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 PROTACs. 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 degraders and the optionality that that might bring in oncology and immunology, and is that an MOA that you're interested in pursuing? Thanks.

Paul Stoffels (CEO)

Yeah. Yeah, we did a collaboration with BridGene, 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 real and medical need, where there's 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 are assembled, we can make differentiated medicines against a number of these targets. We are accessing the platforms like BridGene.

You've 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 is, 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 unmet medical need.

So we basically, that's our process to being able to bring this type of medicines as I just quoted. I hope we will and 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.

Sean McCutcheon (Director of Biotechnology Equity Research)

Mm. Thank you.

Operator (participant)

Thank you. Dear participants, as a reminder, if you wish to ask a question over the phone, please press star one-one 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 Sebastiaan van der Schoot from VLK. Your line is open. Please ask your question.

Sebastiaan van der Schoot (Biotech Equity Research Analyst)

Hey, guys. Thank you for taking the question. In the past, you have mentioned that you see the CLL program as the most likely program to get a fast proof of concept and get to the market. Can you provide your vision on the current progress of the program and the likelihood of a pivotal study after the update later this year? And maybe you can also put the results in context of BMS's recent approval in CLL. Thank you.

Jeevan Shetty (Head of Development Oncology)

Thank you very much for the question. First of all, I'll speak to the program, and then secondly, to the data from Bristol Myers Squibb. With regard to our CLL, high-risk CLL and Richter's transformation studies, the expansion part of the study is to be initiated imminently. We've had very meaningful conversations with the authorities, the 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 U.S. authorities, the FDA, and really work out a program of one set of globally appropriate studies.

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 Breyanzi, 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, 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, the additional translational data, we feel very confident that we're gonna be able to contribute significantly to patients.

Sebastiaan van der Schoot (Biotech Equity Research Analyst)

Great. Thank you.

Operator (participant)

Thank you. Now we're going to take our last question for today. The question comes from the line of Shan Hama from Jefferies. The line is open, please ask your question.

Shan Hama (Equity Research Analyst)

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.

Thad Huston (CFO and COO)

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.

Operator (participant)

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 second. Thank you all for participating and have a great rest of your day.