Orexo Press Conference Dec 23 2025, Summary

Orexo to Divest US Rights to Zubsolv for $91 Million, Refocuses on Drug Delivery Technology

Orexo AB, the Swedish biotechnology company, has announced a strategic divestment of its Zubsolv franchise in the United States to Dexcel Pharma USA. The transaction marks a significant shift in the company's strategic direction as it pivots toward its proprietary drug delivery platform and pipeline of rescue medications.

Transaction Overview

Under the asset purchase agreement signed on December 22, 2025, Orexo will receive:

  • Fixed purchase price of $91 million payable at closing

  • Additional payment of $4-5 million for inventory value at closing

  • Contingent consideration of up to $16.8 million based on Zubsolv net sales performance during 2026 and 2027

The transaction is expected to close by January 31, 2026, subject to satisfaction of customary closing conditions. Zubsolv, a buprenorphine/naloxone sublingual tablet used for treating opioid use disorder, generated net sales of $49 million and EBIT of $17 million over the last twelve months (Q4 2024 to Q3 2025).

Strategic Rationale

The divestment represents the outcome of a comprehensive strategic review aimed at strengthening Orexo's financial foundation and redirecting investments toward areas with the most attractive long-term value potential. The company plans to use the net proceeds to redeem its outstanding corporate bond, which will leave Orexo debt-free and eliminate associated interest payments.

Nikolaj Sørensen, President and CEO of Orexo, acknowledged the significance of the decision: "The launch of Zubsolv in the US in 2013 marked a major milestone in Orexo's history. The decision to divest Zubsolv is equally transformative and was not taken lightly." He noted that the transaction will "accelerate the expected cash flow contribution from Zubsolv until loss of exclusivity" while significantly strengthening the balance sheet.

Impact on Operations and Workforce

Most employees at Orexo US Inc. will have the opportunity to join Dexcel Pharma USA, ensuring continuity of supply and customer support for Zubsolv. However, Orexo US Inc. will continue to maintain operations focused on development programs, particularly the OX390 project.

The OX390 program, designed to address adulterated opioid overdoses related to the current tranquilizer ("Tranq") epidemic in the US, will remain under Orexo's leadership. This project is being developed in partnership with the Biomedical Advanced Research and Development Authority (BARDA), which provides funding of up to $51 million.

Future Strategic Focus

Following the divestment, Orexo will intensify its focus on its proprietary AmorphOX drug delivery technology platform. The company's development priorities include:

  • Izipry™: A rescue medication for opioid overdose

  • OX640: A treatment for anaphylaxis

  • OX390: A solution for adulterated overdoses

  • Biomolecule applications: Expanding AmorphOX technology to GLP-1 agonists and vaccines

The improved financial position will enable Orexo to invest additional resources in developing AmorphOX's potential, particularly in the fast-growing biomolecule sector. The company's business model will be based on partnering, de-risking development, and generating revenues when products reach commercial stage. Orexo also intends to play an active role in commercializing pipeline products, leveraging its remaining US organization and BARDA partnership.

About the Acquirer

Dexcel Pharma USA is the American subsidiary of Dexcel Pharma, Israel's largest private pharmaceutical company. In the press release Doug Boothe, CEO of Dexcel Pharma USA, expressed enthusiasm about the acquisition: "Dexcel Pharma is excited to be adding the Zubsolv product and related commercial capabilities from Orexo into our expanding US operations."

Looking Ahead

Orexo plans to host an R&D Day in Q1 2026 to provide a comprehensive overview of the company's strategic focus and development programs. Detailed financial impact of the transaction will be disclosed in the company's Full-Year Report, scheduled for release on February 5, 2026, at 7 am CET.

With over 30 years of experience and multiple drugs approved globally, Orexo is positioning itself as a specialized drug delivery technology company focused on severe diseases and life-saving rescue medications. The AmorphOX platform, which improves bioavailability and stability for both large and small molecules, represents the core of the company's innovation strategy going forward.

The transaction was advised by Leerink Partners as financial advisor and Steptoe LLP as lead legal counsel to Orexo.


This summary was written by our AI Analyst Tim! If you find something that does not seem right let us know and we will correct him.

The conference is in presentation mode. Your line is muted. The conference will begin when the next party joins. Welcome to the conference call. For the first part of the conference call, the participants will be in listen only mode. During the questions and answer session, participants are able to ask questions by dialing star five 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're now able to close this transaction just before Christmas is very welcome and we think is the right thing for Wärtsilä 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 US 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 US 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 contingent payment or an earn-out, you can say, which could be up to 16.8 million. That will be paid out after the year N26 and after the year N27. With the agreement, Dexel Pharma will take over the manufacturing rights and control the supply and commercialization of sub-salt in the US. Orexo will continue during the transition phase to support Dexel or as long as they need our support. We will do that. So we will still be involved in the sub-some manufacturing at least for 26 and maybe into 27. It will have implications for our employees, but in particular in the US. But one of the reasons why we also decided to proceed with Dexel Pharma is that they offer our US employees an opportunity to join them. We started that process I started that process now and we're reaching out to all of the relevant employees in the US 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 Dexcel will continue to support Dexcel but we will get reimbursed for those 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 US subsidiary, Dexcel Pharma US. And Dexcel have today a pipeline of different projects. They have a portfolio in the US, 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 force who have been successful in the promotion of Zubsolv. So I think Dexcel is the perfect partner in a sense. It's a company who's looking to expand their US business and where they saw a lot of benefits of taking over the Aurex 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 lifecycle of pharmaceuticals where you enter at some point a patent expiry or you have made agreements settlements like we have with a generic company that enable 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 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 acquire of the sub salt. At the same time it also gave us something to calculate which is quite easy to make just looking at the EBIT, the trajectory of sub salt. 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 soft cell business and feed force. At the same time, it's a way for us to basically accelerate the payments or profits that we could expect from this business. And with this transaction, we will remove the financial uncertainty. I know a lot of the investors at least are very keen and I'm 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 the interest in Subsidiary in the US. 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 for Zubsolv. I'll just hand over to Frederick to just take through and maybe repeat some of the financials in the agreement. Yeah. Thank you, Nikolai. So the purchase price of 91 million that is paid at closing, obviously related transaction expenses we have that obviously that's related to adviser costs, but we will also have costs associated with restructuring of US business. So, so, met sales for the last four quarters, for Zubsolv in the US was 49 million and we had an EBIT of 17 million US dollars. In addition to the purchase price, we get paid for acquired inventory, four to five million US dollars, and that will be an estimate at closing and then later confirmed. We have continued payment and earnout payments, an earnout payment of up to 16.8 million US dollars. That's based on the net sales performance in 2026 and 2027. This is based on assumptions that we have conveyed to the potential 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 can 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 would 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 Dexcel prior to closing. That is our obligation. We will be reimbursed for services provided to Dexcel during the transition phase. And corporate bond, as Nikolai said, we will redeem after closing. No decisions have been made, but we are targeting that in the beginning of next year. And 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. And you will receive more information as we go along. And 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'll 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 US and Sweden. We will still maintain US presence or we will be will remain. There will be some commercial competences maintained in the organization in the US, which will help us in our development programs to ensure that they meet the expectations from the US markets and the needs from the US markets. Our US operation is also the lead on our partnership with BARDA. So our Work 390 project, where we received up to $51 million in developing a treatment of adulterated opioids. So that will still be let out of the US organization. We will, with this agreement, we will also have the capital that we now need to proceed with our pipeline projects and to expand the Amorphix 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 ICPR project, which is expected to be filed with the FDA. To resubmit it to the FDA during the summer. Now when we will not have a commercial organization, the plan is to partner ICPR after approval. OH-640, we will now have the money to take it into the pivotal clinical stage to start the upscaling or complete the upscaling of manufacturing and then start the first people to study probably late in the second half of this year. And then we will, as we go along with OX-640, 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 OX-640, is of great value. So in parallel with the development, we will also seek partners for OX-640 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 GNP1 agonist or semaglutide, where we'll continue our non-clinical development to ensure that the formulation together with Amorphex improves the bioavailability that we see for these products today. And also can provide some additional stability to the products. So 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, but with this deal we will definitely have the resources to take this forward. We will also continue our work to test how a morphox could be used in vaccines. We did a big market study last year about the different areas where a morphox could provide most value and vaccines was identified as an area where we could solve many of the compromises 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 on 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 competences in the US but it also could be a full partner out licensing 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 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 that is 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 OX-640, 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 manufacturing 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 added to that project. We also continue to partner the Amorphex technology, let other companies who have an exciting API test their API in Amorphex 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 go into become a full project where OREXO can take one part in that development moving forward on the basis of Amorphex. 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 QP leaders in the different areas to comment on our development program. And with that, I will open up for questions. Q&As, so thank you for listening. If you wish to ask a question, please dial *5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial *5 again on your telephone keypad. If you wish to ask a question, please dial *5 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 Klaas Palin, from DNB Carnegie. Please go ahead. Thanks 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. 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 spent most of their time on Zubsolv today where we will look at their competences 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 In total numbers, I don't see this has any major impact on the Swedish organization. Over time, hopefully this can lead to actually expanding the Swedish R&D department. In the US, 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 features, sales managers offer 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 SLOPSOL. We will then have a period of time where we still have to support supply, financial support in the US. 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 US 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 US. Okay, great. I guess we will get more information about this. On your R&D data. Is there any other balance sheet affecting these transactions? And I just wonder a little bit what's happening with the Modia and Vorbida, for example. So I think here we have removed the possibility for us to work with Modia and and Mobeetah and I think there's a little value left on the Mudiya that we will review as part of the year in closing. So, okay, perfect. This inventory potential positive effect, there's no other liabilities that are connected to this. Sorry, what exactly are you referring to? 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. So that, but that's, that's an exercise that we will get back to you on. So the, I said the basic principle in the agreement is that, that at the time of closing, what OREXO has sold prior to closing, if, if that is returned, then OREXO have to, 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 Rexahn, 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. What package, but for the rebates it's a little more of an estimate and we need to look at how that looks like. So for example the escrow of $3 million that we have is primarily set for to ensure that we will cover the returns that could come from Subsidiary, which is what is on the balance sheet right now. Perfect. Thank you so much and that was all for me. Thank you, Claus. 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 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 an 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 partnering partners are 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 we would, 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, and I know previously you discussed about trying to settle that matter. What is the status now when you sell US subs of commercial? It's very hard to estimate the, there's no doubt that the liability for the DOJ relies with Orexos, so it's not attached to the product and to be very transparent. It's of course something that the acquirer want 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. So this is going to be something that will follow us into the next 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 US administration and I don't think that's been confirmed and US prosecutor for the office that is investigating this matter. So we are in a dialogue. I think there is a, 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, we talked about the contingent payments. I just wanted to, I know you can't give the specifics, but is growth of Zabsolve required for those contingent payments? To be triggered? For the full amount, yes. For most of it, no. The contingent payment 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 we will, if we just meet the forecast that we have, we will We will get to a more than half of the amount of money. 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 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 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 Avis 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 Naloxone. With a very, very big market margin. And just looking at what Mark Narkman 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 US with a US advisor. And have confirmed that we have an attractive product in comparison to Nefi and that there is space for our product in the market. 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 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 an ex-US 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, our court have already taken over the controller supply. So our court 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 US 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 US 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 will 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.

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