Welcome to the conference call. For the first part of the conference call, the participants will be in listen-only mode. During the Q&A session, participants are able to ask questions by dialing *5 on their telephone keypad. Now I will hand the conference over to the speakers. Please go ahead.
Thank you very much, and welcome to this call updating you about the transaction that we completed yesterday evening. And first, I just want to extend my apologies for disturbing you here on the 23rd of December, where most of you probably would like to go Christmas shopping or starting the vacation. But for us, this is a major step and something we've been working intensively on throughout the autumn, and that we now are able to close this transaction just before Christmas is very welcome and we think is the right thing for Orexo to do in our current state.
So we will give you an update about our agreement that we reached with Dexcel Pharma yesterday evening, where we're divesting the U.S. rights to Zubsolv, and we'll provide a little more details on it, but most of it will, of course, be anchored in the press release that we have made yesterday evening. So shortly about the transaction, we have sold the rights to Zubsolv in the U.S. to Dexcel for a net amount of $91 million. We will also be paid for the inventory that we have at closing. In addition, there's an agreement that we will have a continued payment or an earn-out, you can say, which could be up to $16.8 million that will be paid out after the year end 2026 and after the year end 2027.
With the agreement, Dexcel Pharma will take over the manufacturing rights and control the supply and commercialization of Zubsolv in the U.S. Orexo will continue during the transition phase to support Dexcel or as long as they need our support, we will do that, so we will still be involved in the Zubsolv manufacturing at least for 2026 and maybe into 2027. It will have implications for our employees, but in particular in the U.S., but one of the reasons why we also decided to proceed with Dexcel Pharma is that they offer our U.S. employees an opportunity to join them.
We started that process now, and we're reaching out to all of the relevant employees in the U.S. and hope they will join Dexcel, which is a company that I have gained a lot of respect for during this process we have been in for the last several months. The deal closing is expected at latest January 31st. We hope and expect it could go much faster than that. After the closing, as I said before, we will enter a transition phase where Orexo will continue to support Dexcel, but we will get reimbursed for the efforts during that period. Just a short note about Dexcel Pharma. Dexcel is a very large company in Israel. We do the business. Our agreement is with their U.S. subsidiary, Dexcel Pharma US. Dexcel has today a pipeline of different projects.
They have a portfolio in the U.S., among others, also controlled substance. They showed a great interest in both the product, but also in the organization. So part of the valuation that we agreed on, I think, is anchored in Zubsolv, but definitely also recognition about the opportunities for Dexcel to take over and establish the field for us who have been successful in the promotion of Zubsolv. So I think Dexcel is the perfect partner in the sense it's a company who's looking to expand their U.S. business and where they saw a lot of benefits of taking over the Orexo staff. So why do we do this now?
We find this is a very good timing from a value perspective, and it's connected a little to the, you say, the life cycle of pharmaceuticals, where you enter at some point a patent expiry or you have made agreements and settlements like we have with a generic company that enabled them to launch a generic. When that happens, you would normally expect to see sales dropping, and if there are more than one generic, it could be a quite dramatic drop in sales at that time. We now have more or less exactly five years left before we could have the first generic competitor, and that gave a run rate for the acquirer of the Zubsolv. At the same time, it also gave us something to calculate, which is quite easily made just looking at the EBIT, the trajectory of Zubsolv.
We just see right now we are at this time when it still has a good value for a potential acquirer. They will have time to establish their business around the Zubsolv business and yield for us. At the same time, it's a way for us to basically accelerate the payments or profits that we could expect from this business. With this transaction, we will remove the financial uncertainty. I know a lot of the investors, at least, are very keen and are starting to ask more and more questions around how we are supposed to refinance the corporate bond, which expires in March, I believe, in 2028. With this transaction, we will have the money to redeem the corporate bond and take away that overhang for the company.
I will also say a reason why we're doing it right now is that already a year ago, we were approached by a company who had interest in Zubsolv in the U.S. We were approached by more companies during the spring of 2025, and during the summer, we then decided to start a more broad process to ensure we got the optimal value for Zubsolv. I'll just hand over to Fredrik to just take us through and maybe repeat some of the financials in the agreement.
Yeah. Thank you, Nikolaj. So the purchase price of $91 million that is paid at closing. Obviously, related transaction expenses, we have that. Obviously, that's related to advisor costs, but we will also have costs associated with restructuring of U.S. business. So net sales for the last four quarters for Zubsolv in the U.S. was $49 million, and we had an EBIT of $17 million. In addition to the purchase price, we get paid for acquired inventory, $4-$5 million. That will be an estimate at closing and then later confirmed. We have contingent payment and earn-out payments. An earn-out payment of up to $16.8 million. That's based on the net sales performance in 2026 and 2027. And the aspiration is this is based on assumptions that we have conveyed to the buyer.
With that, we have negotiated a continued payment that will follow the sales development and be paid if we reach certain levels in 2026 and 2027. I could say that our aim is probably I mean, there's a reason that we can get everything, obviously, but realistically, we're aiming at potentially half of that. So that will be the aim. $3 million will be held in escrow, and that is to follow the seller's obligations in the agreement. That's related to returns of products sold by Orexo prior to closing. That is our obligation. We will be reimbursed for services provided to Dexcel during the transition phase. Corporate bond, as Nikolaj said, we will redeem after closing. No decisions have been made, but we are targeting that in the beginning of next year.
There's obviously, when the closing is due, we will account for the transaction, and then we need to look at provisions that we probably need to have in the accounts for the transaction. Yeah.
You will receive more information as we go along. I think here, I think it's very positive around the contingent payment that we have a very, very high certainty that we will get a good part of that. I think there's good chances that we will exceed the conservatively set aim. I think there may be a little less chance that we will get the full payment, but that we should get a large part of the payment, I think, is quite likely. So all in all, I think this agreement is very attractive based on where we are and the run rate we have on our EBIT at the moment. So what happens now? As we said before, we will continue to support Dexcel during a transition phase with resources both in the U.S. and Sweden. We will still maintain U.S. presence. Orexo U.S. will remain.
There will be some commercial competencies maintained in the organization in the U.S., which will help us in our development programs to ensure that they meet the expectations from the U.S. markets and the needs from the U.S. markets. Our U.S. operation is also the lead on our partnership with BARDA, so our OX124 project, where we received up to $51 million in developing a treatment of adulterated opioids. So that will still be led out of the U.S. organization. With this agreement, we will also have the capital that we now need to proceed with our pipeline projects and to expand the AmorphOX platform into new areas along the lines that we have already communicated.
But to give a little comments on each of the main projects, we have our OX124 project, which is expected to be filed with the FDA or to be resubmitted to the FDA during the summer. Now, when we will not have a commercial organization, the plan is to partner OX124 after approval. OX640, we will now have the money to take it into the pivotal clinical stage to start the upscale or complete the upscaling of manufacturing and then start the first pivotal study probably late in the second half of this year. And then we will, as we go along with OX640, we now have the capital to take it all the way, but it also will provide data with the final commercial product during this pivotal trial. And that's something that we've heard from several of the potential partners for 640 is of great value.
In parallel with the development, we will also seek partners for OX640 in all geographies across the world. OX390, we are still in the preclinical or non-clinical phase at the moment, and that means that we are finding the optimal formulation. We are doing the first in vivo studies to be able to pinpoint which formulations we should take into humans. OX472, that's our GLP-1 agonist or semaglutide, where we'll continue our non-clinical development to ensure that the formulation together with AmorphOX improves the bioavailability that we see for these products today and also can provide some additional stability to the products. That is something that is still in a preclinical phase, and we have not given any guidance on when we expect to take the next steps. With the sale, we will definitely have the resources to take this forward.
We will also continue our work to test how AmorphOX could be used in vaccines. We did a big market study last year about the different areas where AmorphOX could provide most value, and vaccines was identified as an area where we could solve many of the compromises you have with the current formulations, and now, with the capital we receive, we can proceed with some of those early testing, which is not that costly, but still, when we start, it's a commitment to continue. The plan that we have for each of these projects is now we have the financial means to take it forward without slowing down.
But of course, we will continuously seek partnering to ensure we can finance more projects than these and also take these projects all the way to commercial stage where it could be with some involvement with Orexo since we will have some commercial competencies in the US, but it also could be a full partner outlicensing to a third party. So what are we going to expect from Orexo moving forward here? We are already today, I would say, the global leader in nasal powder delivery, but that's still on paper as we have not had the first product on the market. But looking at what we can do with the powder compared to other formulations with nasal powder, we at least have not been able to find someone who offers the same advantages as we do with AmorphOX.
We will take this technology and look into the areas where we think we can do at most value. We think those in biomolecules at the moment, more particularly in GLP-1 agonist and in vaccines. We'll also develop our projects into what we call value inflection points, and that is individually set for each of the projects. It's basically listening to potential partners. Where do they see that we have a major value uplift? For OX640, some of the feedback we have received from larger companies is that they still find this is a little early because we have not done the first studies on the final formulation, which has been manufactured in the final manufacturing or commercial manufacturing process. So to be able now to take this into the next phase, we find this is significantly value add to that project.
We also continue to partner the AmorphOX technology, let other companies who have an exciting API test their API in AmorphOX and do feasibility studies. And we have several of those have been ongoing. We have dialogues with more companies, and we, of course, aim at some of these projects going to become a full project where Orexo can take one part in that development moving forward on the basis of AmorphOX. I know it's December 23rd, and also from an Orexo perspective, we've been focused on closing the deal and not really on preparing large PowerPoint presentations for today. So we will host an R&D day during the first quarter where we'll provide more in-depth information and involving some key persons from our R&D department and probably also some external Key Opinion Leaders in the different areas to comment on our development program.
With that, I will open up for Q&As. Thank you for listening.
If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Klas Palin from DNB Carnegie. Please go ahead.
For taking my questions and congratulations for the transaction, at least the agreement. But I just wonder if you could describe a little bit further how you believe the organization will look like post-Zubsolv. If it's possible to give some more details.
So we have two legs here. We have the Swedish organization, and in Sweden, there are people who spend most of their time on Zubsolv today, where we will look at their competencies and how we can use that in some of our other projects. So there will be some change of roles and responsibilities in Sweden, but in total numbers, I don't see this as any major impact on the Swedish organization. Over time, hopefully, this can lead to actually expanding the Swedish R&D department. In the U.S., it's different because most of the people are, or nearly everyone are working the majority of their time with Zubsolv. And here, I'm very pleased that basically all of the field force, sales managers are offered a position. Several of the head office functions are also offered a position with or will be offered a position with Dexcel.
So they will have an opportunity to continue with Zubsolv. We will then have a period of time where we still have to support supply, financial support in the U.S. We will have to support some market access activities to ensure all of the different agreements that we have will be assigned over to Dexcel. But as these different activities cease, we will need to streamline the U.S. operations into a relatively small office that will contain some medical resources and some commercial resources. But it will be a small but very strong office that we will have in the U.S.
Okay. Great. I guess we will get more information about this on your R&D day then. And just is there any other balance sheet affecting these transactions? And I just wondered a bit what's happening with the MODIA and vorvida, for example?
So I think here we have removed the possibility for us to work with MODIA and vorvida. And I think there's a little value left on the MODIA that we will review as part of the year-end closing, so.
Okay. Perfect. And this inventory for potential positive factors, no other liabilities that are connected to this?
So sorry, Klas, what exactly are you referring to?
Yeah, yeah. I guess you don't have any other liabilities on your balance sheet that will be sort of affected by this that is not included in the transaction.
No, but we.
Except for the bond.
Yes. Okay. No, so when we do the annual accounts, we will look at provisions. Obviously, there could be liabilities in terms of rebates and returns that we need to accrue for. But that's an exercise that we will get back to you on.
So the basic principle in the agreement is that at the time of closing, what Orexo has sold prior to closing, if that is returned, then Orexo have to cover that return. We will have to pay the rebates for the products that we have shipped into the market. So the rebate agreements with the payers, if there are products that are sold, which there will be after closing, that is sold by Orexo, we will cover the rebate for that. And we need to do the math because there will be some kind of judgment call on particularly the rebates. The returns, we know quite exactly which company has sold what package. But for the rebates, it's a little more of an estimate. And we need to look at how that looks like.
For example, the escrow of $3 million that we have is primarily set to ensure that we will cover the returns that could come for Zubsolv, which is what is on the balance sheet right now.
Perfect. Thank you so much. That was all for me.
Thank you, Klas.
The next question comes from Samir Devani from Rx Securities. Please go ahead.
Hi guys. Congrats on the deal. Nice little Christmas present for shareholders and for us writing on you. I've got a few questions, actually. Maybe I'll just kick off with the sort of cash runway post this deal as you now model the business going forward. If we were to assume, I know you mentioned that you're reasonably confident of getting around half the contingent payment, but if we just assumed no further contingent payment, how far is the cash runway for the business post this deal?
I think, Samir, it's a question with several answers because it depends a little on how far we are expecting to take the different projects without partnering and what other activities that we will assume. I say if we just take the existing projects, we can take these projects to approval, but then we won't have any money for commercialization. But of course, we will be looking for partners in parallel with that process based on what we know right now. Then, of course, things can happen both positive and negative during the process.
So we have the money to develop the products, but you also then want either you have a partner and then you will have more runway, or you would need to commercialize and then you would need to, or you decide that you see a value in commercialization and then there are not enough money here to start a commercialization of any products in the US. So it's a strategic question. When do we see that and when do we expect partnering and what is the aim for commercialization? But as we see it right now, it's a stable platform for the next two years. And then in that process, we would, of course, seek to find partnering and additional financing from partnerships that could support the organization.
Okay. Fair enough. Second question, just on the DOJ investigation. I know previously you discussed about trying to settle that matter. What is the status now when you sell U.S. Zubsolv commercial?
It's very hard to estimate. There's no doubt that the liability for the DOJ relies with Orexo, so it's not attached to the product. To be very transparent, it's, of course, something that the acquirer wants us to indemnify them if there should be anything on the product. But we're very confident this is isolated to the company and we are in a little back-and-forth process around those settlement discussions. This is going to be something that will follow us into the next year. But I will be very, very cautious of not providing any exact guidance here because it's also, as you know, there have been some volatility in the U.S. administration, and I don't think that's been confirmed. And U.S. prosecutor for the office that is investigating this matter. So we are in a dialogue.
I think there is, in one way, we're, of course, taking away what they have been investigating, which might put things in a different light. But I will refrain from going into too much speculation here.
Okay, and then just moving on, you talked about the contingent payments. I just wanted to. I know you can't give the specifics, but is growth of the Zubsolv required for those contingent payments to be triggered?
For the full amount, yes. For most of it, no. The contingent payments are based on the basis of the forecast that we have provided, and if we meet the forecast, we will exceed more than half. If we don't, we will have less. If we exceed our forecast, we will get more, so if we just meet the forecast that we have, we will get to more than half of the amount of money.
Okay. I think I just got a couple left. Just on 640, you mentioned that you're considering now doing another study. I just wanted to make sure that's what I heard because I think previously we had been waiting for sort of the commercial data from ARS in terms of it had been a slightly slow uptake, and I think you're waiting for a bit more data before partnering. Is it now the case that you're definitely going to do the new study yourself? And if so, when can we assume that that could get done by?
So we have seen, and we've seen during the quarter, we saw ARS actually had, I think, two and a half times growth quarter- over- quarter. They exceeded $30 million in sales in the third quarter in the market. If we take a parallel back to the naloxone market, this is way surpassing the introduction of Narcan with a very, very big market margin. And just looking at what Narcan ended up with, about $400 million, of course, in a much smaller market, I think this is on a good trajectory. Then there can be some seasonality. I understand in this market's allergy, so they were a little cautious about the growth in Q4.
We have in parallel, we have made a larger market research in the U.S. with a U.S. advisor and have confirmed that we have an attractive product in comparison to neffy and that there is space for our product on the market. And now when we have secured the capital to take the product forward, we will enter into a clinical testing, and the aim is to start that during the second half, more in Q4 than Q3, with the results then coming early next year. And what we're looking at, can I just say, is a nasal allergy challenge study where we're using the commercially manufactured product.
Okay. That's understood. And then just my final question is just on ex-U.S. Zubsolv. What's going to happen there? Because you've been in control of the manufacturing and supply. So what happens to that going forward?
They have actually. Accord have already taken over the control of supply. So Accord have set up their own manufacturing within their own facilities, which is basically starting now. So we will not have shared manufacturing and supply between the U.S. and Europe, which I also think is an important factor in this. That should the two parties have to share the manufacturing process, that would have been more complex at least. But now we have two separate manufacturing plants, and none of them have actually licensed and have approval to supply to the other markets. So U.S. and Europe has been separated from that side.
That's great. Congratulations and Merry Christmas.
Thank you very much, Samir. Thank you. We have not received any further questions, and with that, I'm just pleased that we could announce this to our shareholders and to our employees just before Christmas, and I look forward to share much more details about Orexo in the year to come here. And as you know, we will invite for a Q1 report. We will have a Capital Markets Day on R&D Day during Q1, and we will have our fourth quarter results presented early February, so February 5th, and I look forward to provide that and also more details on this transaction as we proceed, so thank you all and happy holidays and Merry Christmas. Goodbye.