Welcome to the third day of the Jefferies London Healthcare Conference. I'm Sian Hammer from the European Pharma and Biotech team here at Jefferies, and I'm happy to have with us here today the CEO of Galapagos, Henry Gosebruch, and also the CFO, Aaron Cox. Thank you so much for joining. Perhaps we could start with some introductory remarks about Galapagos.
Excellent, yeah. Excited to be here. Thanks to Jefferies for hosting us. We are in the middle of transforming Galapagos. As maybe many of you know, Galapagos is actually one of the oldest and quite successful European biotech companies. It used to be the biggest market cap in Europe in biotech a few years ago. All that history has given us the great balance sheet we have now. We have about EUR 3 billion in cash. We have some other assets on top of that that can drive additional value. We are focused on exiting our current cell therapy business and then using the EUR 3 billion in cash we have to build a new pipeline and some new programs. As of a couple of minutes ago, I checked, we are trading at a bit over EUR 26, and we have EUR 46 in cash.
Therein lies the opportunity, which we're quite excited about.
Thank you for that. Obviously, a lot has happened over the past 12 months, and let's address that first. Given the decision to abandon the planned separation into two separate entities, what's your revised strategic vision for Galapagos, and how does that better serve shareholder value?
Yeah, so just to step back, the board over really the last 18 months had been thinking through how to best deploy the capital we have. That ultimately, about a year ago, led to analysis around splitting the company. That is the announcement she referred to, where in January, we came out and we said, "Okay, we are going to split the company. We will leave about EUR 500 million behind at Galapagos." We put EUR 2.45 billion into a new entity creatively named XYZ Spinco that was going to go out and build a new business. As time went on and as the cell therapy industry continued to evolve, I think specifically the current commercial programs continue to see challenges in the market. You have seen most of the strategic players really bet on in vivo on some new technologies.
You just heard Sam talking about some of those new technologies. The board continued to look at things. Over the summer, I was asked to come in, and basically the mandate that Aaron and I were given is go exit cell therapy, see if you can sell it. If you can't sell it, go exit it. As I said, use the capital to build a new business. That is what we are focused on. We think that ultimately we're going to be able to put that capital into opportunities that we think can make more of a difference for patients. We want to find opportunities that are relatively de-risked but can create meaningful commercial opportunities, meaningful new medicines.
As the board looked at that relative to continuing to invest in ex-vivo CD19-based CAR-T technology, the board felt investing in new approaches would be more shareholder value conducive than sticking with the existing cell therapy platform.
Understood. You touched on your cash position, which is you have EUR 3.1 billion in cash. How do you plan to allocate capital between sort of continuing operations, potential business development opportunities, and potential shareholder returns, especially given at the moment you sort of lack distributable profits?
Yeah, I'll jump in here. We announced a few things on our last earnings call, and in conjunction with the announcement of the intention to wind down the cell therapy business, we announced we expect year-end cash this year to be EUR 2.975 billion-EUR 3.025 billion. We also announced the capital required to effect this wind down. We do expect EUR 100 million-EUR 125 million of additional operating costs related to getting through the works councils processes in Belgium and Netherlands, which is required given our domicile and where these operations are held. We also announced an extra EUR 150 million-EUR 200 million of actual wind down costs. These are more restructuring costs, severance costs, contract termination costs, things like that. The last important announcement we did was we expect to be cash flow neutral or positive by year-end 2026.
This is through, obviously, the interest income associated with the cash balance, which we've had EUR 77 million through the first nine months of this year. We also have a few assets that Henry alluded to earlier in terms of tax credits. These are actual tax refunds that we expect over the next several years of EUR 20 million-EUR 35 million a year. Royalty income related to some royalties we have with Gilead and Alpha Sigma of EUR 15 million-EUR 20 million a year. We expect to be in a great position by the end of next year. Post wind down, we've also indicated an employee base of 35-40. Given all these different cash flow items that I just mentioned, you can see pretty quickly how we get to a cash flow neutral or positive position. Yeah.
Just to build on Aaron's answer, post the cell therapy, there's really only one program left from the legacy Galapagos platform, which is a TIC2 immunology program that is finishing up phase two studies. We announced that we expect data early next year. At this point, the studies are fully enrolled. The spend is sort of minimal on that. To your question, it's really cell therapy, a little bit in the TIC2, these restructuring costs, and then all the capital really will be deployed on business development. In terms of capital distributions, I think you asked, that is not something we're focused on now. Under Belgian rules, a 75% shareholder vote is required to do that. Gilead owns 25% and would rather us have our current strategy of deploying that capital into business development.
As long as we have that partnership with Gilead and the constraint with the shareholder vote, that is not going to be a near-term strategy.
Understood. That makes sense. We sort of touched on how M&A or BD is a sort of focus for Galapagos right now. Could you perhaps elaborate on any specific criteria and evaluation framework your team are using to assess a potential acquisition in the future?
Yeah, obviously, we've put a team together that's done hundreds of transactions in various settings. It is a team that's done this before and transformed companies before. We're going to be very disciplined. As I mentioned, we're trading at this big discount. I think one of the reasons is that there's uncertainty around cell therapy, and then there's uncertainty on how we're deploying that capital. We will be looking for very de-risked opportunities. We will be working with our partners at Gilead. Again, Gilead owns 25% of the company and is an existing partner. We think working with them creates strategic angles and areas of synergy or areas of insight that is hard for any biotech to bring alone. We think it's in shareholders' interest if we partner with them closely, which then leads us to areas that they're strategically interested in.
I&I, which was really the original premise of Galapagos and Gilead working together, was really immunology driven or oncology. Those are the main two areas. It's not exclusively what we're looking at, but we see a lot of opportunity in those two spaces. We'll be looking for, again, de-risked or post-POC assets. Let's just say the phone is very actively ringing. I think a lot of biotech, despite the slightly better environment, is clearly looking for capital and looking for creative ways to partner.
Understood. That sort of BD opportunities, is that a mixture of both M&A and also in licensing?
Absolutely. I mean, we can be very flexible. I mean, going forward, the kind of go-forward team is 35-40 people. We can buy companies and welcome teams to Galapagos and effectively have them join us and then in the context of Galapagos continue to develop whatever they're working on. We can use our capital to deploy it into independent companies that then will advance their programs. We may own rights. We may have opt-in rights. We may own equity. It is a number of different ways, but both partnership and M&A very much on the table.
Got it. Pharma is facing this massive patent cliff in the coming years. There is sort of pressure on all fronts to execute deals. How do you assess the risk of potentially overpaying for an asset or a company, especially in this BD environment?
Yeah, look, we're encouraged by the M&A environment being a little bit better and seeing a little bit more activity. Obviously, valuations have come up a bit in biotech as well. For the most part, I mean, I love having EUR 3 billion. It's unique. It makes us one of the, I don't know, three or four biotechs maybe with a sip of firepower. That being said, we are going to pick our spots very carefully. Situations that are likely to be very competitive with big pharmas looking to fill their LOE issues are unlikely to be focus areas for us. I think there's a lot of opportunity in meaningful commercial programs, meaningful late-stage development programs that, again, can make a clear difference for patients, but that may not necessarily be of interest to big pharma.
Again, when you're solving a double-digit billion LOE problem, you may not prefer to look at a $500 million type opportunity. For us, that can be a really interesting opportunity if we see the right value. We will be very financially disciplined. Again, if it takes us a little bit longer to get a deal done, it takes us a little bit longer. We're in no rush. We want to do a good deal. We want to create value. We want to work productively with Gilead. Most importantly, we need to do the right deals.
Great. You just mentioned Gilead. We know they own 25% of Galapagos, and you have this existing collaboration with them. Your partnership with them has clearly been a sort of cornerstone for the company for many years. How do you see that relationship evolving post the cell therapy wind down, given that Gilead is a big player in CAR-T themselves?
Yeah, the relationship is really more driven on the future of Galapagos, right? Working together productively, again, to find new opportunities, to find pipeline programs that can create value for both of us. I have known some of the leaders at Gilead for many years, and we have really established a quite collaborative, productive relationship. Again, as I talked about, I think working together, we can create opportunity that is hard for any one biotech to create alone. The focus really is on finding these assets that can be win-wins for both of us.
Got it. Could you remind us of the OLCA and what it means for Galapagos going forward?
Yeah. The OLCA she's referring to, that's the name for our overriding partnership agreement with Gilead. That was done about six and a half years ago. That partnership, again, when Gilead put about EUR 5 billion into Galapagos, that agreement allows Gilead to opt into U.S. rights for POC stage assets for $150 million upfront. Given that most things we're looking at, U.S. rights will be worth a lot more than $150. We're talking to Gilead about renegotiating that, and they've said very publicly that they want to enable us to do win-win transactions. They've said very publicly that they will be working with us to rework these terms. They want us to be active. They want to contribute to deals.
There are deals that we've evaluated, taken to our board where they offer to co-fund with us, take the development, have much bigger opt-in payments down the road. Those are the type of reworking that agreement that we're talking to them about. Again, at the end, they're very motivated to work with us constructively to find those opportunities. We really don't see that existing agreement to stand in the way of us working productively together.
Makes sense. You spoke just now about sort of Gilead being involved in those BD discussions. Could you speak a little bit more about to what extent they're involved in terms of deal sourcing, discussion, due diligence, and how should we expect them to contribute basically in that process?
Yeah. We have a very active dialogue with them. In some cases, we bring opportunity to them. In some cases, they bring opportunity to us. Because again, with our capital and our ability to take maybe some development spend or other things, there are things we can do that they can't do on their own. Of course, Gilead is a very sophisticated company. They will do a lot of deals on their own. I mean, particular earlier stage deals where maybe there's still significant development risk, that's not as owned. We're focused on, as I talked about, we're more late-stage focused. For those early deals, they'll probably do all of those themselves. For more developed programs, again, they may do some of them on their own, but others, I think, again, will look to work together. I would say it's a close coordinated effort.
Obviously, they have a much bigger set of resources than we have. We need to be very thoughtful where we invest our BD teams' time and make sure it's something that could align with them. Again, that's the relationship we've built.
Got it. If we just switch gears a little bit, and you touched on this earlier, what really drove the decision to wind down the cell therapy business, and what is the current status of that wind down?
Yeah, at a high level, it was really a very careful analysis by the board that went on over quite a period of time to really think through, on the one hand, what is the opportunity for another CD19 team-based ex-vivo CAR-T technology in the market that may have some advantages over existing CAR-T proof programs, but is fundamentally still an ex-vivo CAR-T relative to the pretty significant capital that's required to get that through pivotal studies and on the market. I mean, there's definitely an investment case there, but it's one that is difficult. You have to believe that, and actually, just as we walked in, Sam was talking about that, you have to believe that in vivo CAR-T won't be a significant player. You have to believe that maybe TCEs won't be as much as is anticipated.
As the board kind of put that all together, just given the capital that's required, felt that there would be other areas where we could create more shareholder value than continuing on that journey. I think that's been confirmed by not just Galapagos, but many other players in ex-vivo, either looking to exit ex-vivo or looking to build on in vivo TCE, whatever newer technology platforms are. It's sort of consistent with that. It just speaks to the inherent challenges of ex-vivo, which again, I think one can overcome them, but it's a question of what's the capital required and what's the time it takes and what's the risk relative to, again, other opportunities where there might be a better path to create shareholder value.
Got it. Where are we in that wind down process?
Where we are in that wind down. We announced, as Aaron talked about, we announced, I guess, what, three, three, four weeks ago now, the intention to wind down. The way it works is as a management team, as a board, we can make that decision. We can recommend that decision. It is subject to consultation with the works councils in Belgium and the Netherlands. We're about a month into discussions, had a really good meeting with them just the other week, met with them early on as well. That is inherently not perfectly predictable how long that takes, but it usually takes a couple of months. We're making good progress, and we expect to have that concluded at some point in Q1.
As we have more clarity how that's exactly working out and what it'll ultimately cost us to execute a wind down, we'll update the market. Most likely that'll be when we come out with our full year results, sometime in Q1.
Makes sense. I know this is only an intention to wind down. If I'm not mistaken, you have said that you're potentially still open to an acquisition of the cell therapy business for the right price. What specific characteristics would constitute a viable proposal for an acquisition of the business?
Yeah. We have said it publicly the other day. We have offered to sell the business for EUR 1, and we have offered to put capital into consortiums to acquire the business. We are trying to really be as accommodating as we can. Viable offer really means can a group raise the kind of capital that does two things that, A, can advance the business, but, B, can also take on the employees and especially with an eye toward the Netherlands and Belgium, take on all the social plans and the employee provisions that one has to stand behind. We as a company, we have the balance sheet. We can do that. We can take care of our employees. We want to treat them as they deserve.
What we do not want to do is put the business into somebody's hands that does not have the capital to do either one of those. We remain open. If we do not have to go through the wind down, I would welcome the opportunity to sell it. Raising the capital is the challenge.
Okay. What does the wind down mean for your partnerships with Thermo Fisher, Lonza, and other companies within the cell therapy business? Is it complicated to terminate those contracts?
I wouldn't say it's complicated per se to terminate or to work with them on a transition. It'll just take time. I mean, these are not light switches where the minute we have a works council resolution, we can turn the business off and everybody moves on. We're going to be very thoughtful. We're going to make sure that patients in the existing studies are well taken care of, that we work on a transition plan, that anybody who has been offered this therapy as part of a clinical trial, that we continue that. It'll be some time to execute all of that. Again, we can't sort of perfectly predict each one of those steps, but we expect to be done at some point next year. Again, as we have more clarity on exactly how that works out, we'll let you know.
Aaron gave the broad financial guidance. That is our best estimate. Again, to the extent we can refine that as we get into next year, we will. We should have a lot more clarity in Q1, and then we will be able to communicate that to the market.
Okay. And then just switching gears slightly, you touched on your TIC2 inhibitor. What's the plan for this asset, and what's the level of confidence that it will read out positively in the phase three enabling studies?
Yeah. Prior to our arrival, the company had already started a partnering process. I think the reason is that TIC2 is a pretty validated pharmacology at this point. Obviously, there is an approved drug. There are a number of other late-stage development programs. I think people know that mechanism. It is an interesting mechanism, even though you can argue that one approved drug has not done as well commercially as some people expected. We have pretty high confidence that we will see a clinical response. The question will be, do we think we have a competitive profile? We will look at that very objectively. Unless it beats what we would consider a pretty high hurdle for differentiation, we would most likely partner with somebody that has the infrastructure that can put that into a broad late-stage immunology development infrastructure.
For us to do it alone to build all that capability would be a pretty high hurdle. We do think there's some nice preclinical differentiation. We'll see how it plays out in the clinic. If it does, great. It's pretty clear it's not valued at our current level. If it does, great. If it doesn't, then we'll move on and we'll focus on other areas.
Makes sense. Finally, what catalysts should investors look for over the next 12 to 18 months that could be inflection points for the Galapagos story?
It's really more the things we talked about. A bit more clarity on the exact wind down and the exact timing and cost of that. It's the TIC2 we just talked about. Of course, all eyes will be on how do we deploy the capital? What's the first deal? What's the second deal? Now, look, that may happen next year. It may not happen next year. I mean, again, we want to do the right deal as opposed to we have to do a deal next year or at a very specific time. Clearly, a deal could be a big catalyst, but we're not going to aim for a specific time to get that done. We want to be selective and financially disciplined.
Fantastic. We have about a minute left. Do we have any questions from investors?