Orexo AB (publ) (ORX) Earnings Call Transcript & Summary

Welcome to conference call. [Operator Instructions]. Now I will hand the conference over to the speakers. Please go ahead.

Good afternoon, everyone, and good morning to those of you dialing in from the U.S. I'm Nikolaj Sorensen, and I'm here together with Orexo's CEO, Fredrik Jarrsten. So today, we're going to go through our fourth quarter and year-end results. We will provide a business update. This time, it will be a little special because of the transaction we just completed, as most of you are probably aware of, and the divestment of ZUBSOLV. So we will have a lot of focus on the transaction and the implications on the organization and the same for the financials. The financials have a significant impact from the transaction, of course, but also the way that the financials are structured is -- makes it a little more difficult than usual to analyze and understand the implications for the company going forward and even the performance in the last quarter. So Fredrik will talk you through that. And then we will end up with a Q&A session. So very shortly, the quarter in brief. We signed a deal with Dexcel Pharma on the 31st of December after -- or we closed the deal on the 31st of December after signing it on the 23rd of December. So as you can understand that a lot of activities happened over Christmas for many of the employees and the leading positions in Orexo, both in the U.S. and Sweden. This divestment has taken a lot of efforts for the company throughout the autumn and actually even early summer. It has been intense with several companies competing more or less until the last minute for the transaction. So that has caused a lot of work for the company with both due diligence and entertaining management presentations and others during the autumn. So this has been the big focus for us in the Q4. And of course, that has some implications on our ability to go into details about Orexo moving forward right now. And we have invited for an R&D Day in March, where we'll present a little more about plans for our research and development in more details. So one of the main drivers behind the deal is, of course, to strengthen our financials, but it is to be able to focus what I would say is the core of Orexo moving forward, and that's the AmorphOX platform or the AmorphOX technology. This is, you can say, where everything will spin out of is that technology platform, which is more like a concept than individual, because for every molecule there will be some unique features, different excipients, different ways of manufacturing, but there are some core concepts that are shared across all of the projects. And this is where we need to excel. It's around that technology and our ability to bring in more products on the platform, hopefully, both in partnerships and also some of them led by Orexo throughout most of the development. I'll come back to that a little later. I will also say the Dexcel agreement closed on December 31, but it's far from over. We are in a transition process that will go throughout all of this year and maybe even into next year, where Orexo will continue to support Dexcel with certain functions and expertise to help them taking over and ensure we have uninterrupted supply of ZUBSOLV to the market in the U.S. So we have a tight and daily relationship with the Dexcel leadership. For R&D, we have -- we're starting to talk about 3 different categories. Here, we highlight 2 on this summary. It's what we call exploratory research. That's one we are working to see new application areas for our AmorphOX platform where we think there could be significant opportunities moving forward. As you know, we announced during the autumn that we're working with semaglutide, but we're also working in vaccines where we have worked a lot with Abera, but now we're ready with our increased financial strength to broaden that perspective, and we have engaged some vaccine experts that will advise the company moving forward. We then have our own projects, what we call the Orexo projects. We have a pivotal trial for 640. We are now planning that for Q4 this year. For 390, we are working a lot with our formulations, and that is to prepare for the first in-vivo proof-of-concept study, which is going to start in this quarter. And then IZIPRY, we are making good progress towards the planned filing in Q3 of this year. We'll come back to more to the financials. But of course, it's quite nice to look at the bank account when we closed the year of '25 and see that we have SEK 912 million on the bank account, which is a little increase from last -- the 31st of December, 2024. So about the ZUBSOLV transaction. As you know, it was acquired by Dexcel Pharma. Dexcel is the largest privately held pharma company in Israel, but they are now expanding heavily into the U.S. market. They have some branded, but a lot of generic products in the U.S., and they were highly interested in acquiring a full field force that would be able for them to build the portfolio around that field force. So all of our sales reps and sales managers accepted an offer from Dexcel to join them between the 23rd and 31st of December. So again, something to consider over Christmas. And we are very pleased to see that all of the employees who got that proposal accepted the offer from Dexcel. That enabled us to close the deal on December 31 and are now moving into the transition phase. One thing that you should highlight and those of you who have read the report is that we -- simply based on the IFRS way of doing accounting, we have to focus on what we call continued operations and discontinued operations. We will come back to that a little on the financials. But in the continued operations, it is our R&D, our pipeline, our existing partnerships, both the commercial products like Edluar, Abstral, ZUBSOLV Europe and now also ZUBSOLV U.S. And that means that in Sweden, that's basically all of the staff in Sweden from R&D, business development and headquarter. In the U.S. continued operations, even after the transition, we will have medical affairs in the U.S. So Chief Medical Officer will stay with the company. We will have some R&D project management working with BARDA. And we also have -- we retained some commercial resource in the U.S. and focusing on commercial strategy assessment of new opportunities and also ensuring that we have the right focus areas in our own development. During the transition, however, we will need -- we retained some resources. And this is important because if you look at the OpEx for the continued operation, that actually includes all of these transition resources that were all of the expenses associated with them for '25 is included in the continued operations. And they will continue at a certain period of time to support the transition, and that's both within finance, market access, supply, distribution, regulatory support, for example, within REMS or drug safety. All of these services are reimbursed to some extent by Dexcel. And the plan is when Dexcel build up their own capabilities, the support from Orexo will decline, and then we will restructure our organization accordingly and stepwise following the time line for Dexcel to take over full responsibility. So when you look at our continued operations, that does reflect resources and the cost associated with resources, which are not expected to stay with Orexo long term. Discontinued operations, on the other hand, that's basically what has left the company, and that's the field force from an OpEx, that's, of course, all revenues associated with ZUBSOLV, but also variable costs like marketing expenses and so forth are within the discontinued operations part. So when you look at the financials, the continued operation is not the OpEx that we expect to continue with because a lot of that is associated with the transition phase. And the discontinued operations is kind of the pure ZUBSOLV sales efforts. The time line, I talked about that before, we're signing and closing between 23rd and 31st. We are now in 2026. We'll have this transition phase, which is a lot of work right now, but we expect that to decline stepwise during the year. And we are now planning then for -- we can say, we're already moving towards that the new Orexo. We say March here, but that's where we are planning to do some of the more -- we have our R&D Day where we'll share some of the details, but also do some of the organizational changes. So in the new Orexo, the big focus, as I said before, is around the AmorphOX technology, and I will come back to some more details on this later. So coming into continued operations. So what are we going to move forward? As I said, the big focus and where we really need to excel is everything around the AmorphOX technology. How can we expand the use of the technology, and this is our core competence is that technology all the way from new formulations to manufacturing and supply in the commercial scale. And to do this, we are looking at this in 3 different buckets. So one area is what we call explore the AmorphOX technology. This is where we are finding new areas to apply the technology. What we get from that will lead to some own projects where Orexo decide that we actually start a real project. We are starting -- planning for clinical trials and a firm development plan interacting with regulatory authorities, for example. So these would be projects where Orexo will invest up to a certain point in time where we see that there is a big value inflection where it's time to get in partners. And the third area is partnering the AmorphOX technology, basically making the technology available for other companies who can benefit from the AmorphOX technology and where Orexo will then support them during their development. Moving a little into more details of that. So in the exploring space, we are basically looking at areas where we can move from, we say, incremental improvement, you can say, which is patient convenience. We want to focus more where we can transform the drug delivery. And this is why we have a big focus on larger molecules, because a lot of the large molecules today are injected, they have issues with stability. And we think with the AmorphOX, we can enable new delivery technologies, for example, through the nose, but could be other ways also. And we can definitely address some of the stability issues with these larger molecules. And while we are focusing now is simply to test how do we apply AmorphOX technology to these areas, reach what we call or show proof-of-concept. And when we've done that, then have a decision whether we should out-license the technology to our partners or start our own project. And the focus we have at the moment is on GLP-1 agonist and in particular, semaglutide, where we continue to work on the formulation. We have some brilliant ideas, I hope, for how we can improve the bioavailability even further, so making it a real competitive alternative in this space. And this is something that we are working on at the moment. We also work on vaccines. We have, as you know, worked together with different vaccines companies. The one that has been public has been Abera, small Swedish company. But with the resources we have now, we have retained or have created collaborations with research partners from -- who are active in academia, both in Sweden and the U.S. to advise us and also to work and see if we can apply our technology to some of their projects. So this is really exploratory, but again, something that we think could turn out to really interesting opportunities moving forward. The next area is our own projects or what we call proprietary projects. And that's where Orexo see that we have an opportunity to basically take some of the ideas we have into a project where we move it in with a clinical development plan, we interact with regulatory authorities. We have a dedicated team and a time line for the projects. And the focus here at the moment are well-known projects to all of you, I believe, it's OX640, where we're now planning the first pivotal clinical trial. It's a nasal allergy challenge study that we're planning for Q4. We also -- to do that, we need to upscale our commercial manufacturing and basically use the commercially manufactured product for that clinical trial. So that is ongoing at the moment. IZIPRY, we are looking for filing in Q3 of this year or second half of 2026. And we are now -- because we don't have a commercial infrastructure, we'll, of course, be looking for a partner for the commercialization in the U.S. OX390, this is an NCE, and we have to do a lot of testing in the beginning and both on formulation. And now we're planning for the first in-vivo testing, which is scheduled to start here in Q1. And then the -- we are looking -- we believe that the technology has opportunities to be used by other companies. So we are looking for other companies where they see that they have issues with the formulation while the AmorphOX technology can support their development. Here, again, we have worked, for example, with Abera that we think we can support. Some of you have been with us earlier know that we did have a project with Sobi. We have other or several others that are nondisclosed where we are in a more feasibility study. But this is an area where we think we can step up with the added resources, and we're looking to see how we can work even more intensively with business development to ensure we can expand that portfolio of partnerships where Orexo is taking very limited risk in the development. We can take some risk, but most of the risk will stay with the partner. And that is something where we can, again, apply the technology, create better utilization for our facilities and learn more about how we can expand the use of the AmorphOX technology. Long term, the ambition is, of course, to grow and have a portfolio of commercial stage partnerships where the main business model is to find partners who will basically pay upfront if it's our own projects, royalty milestones. If it's our AmorphOX technology projects, the partner will cover most of the expenses with some margin to Orexo, we hope, during the development. That's the ambition. But we also want a royalty, which reflects the patents that come with the technology all the way throughout the commercialization. Today, we have 4 revenue-generating partnerships. As you know, none of them are based on AmorphOX, but they are still generating revenues for Orexo. So ZUBSOLV U.S., we have an earn-out. Fredrik will talk more about that. ZUBSOLV Europe, it's been a little slow during this year. That's because Accord have built up their own manufacturing capacity and it's actually sitting with EMA right now for approval. If that goes through as expected, then we think Accord will be much better equipped to participate in the competitive pricing environment we have in Europe. Abstral and Edluar are both lacking towards the end of the contract in several markets and also with the patents, which is reflected in the exact revenues that Fredrik will talk about shortly. Then on our discontinued operations, this is where we normally spend most time, but this time, I just have one slide on ZUBSOLV, more to leave it. But we're pretty pleased with the development in the fourth quarter. In U.S. dollars, sales actually grew in the quarter. So we had $14.6 million compared to $14.1 million last year. If we're also looking at last quarter, we were $12 million and now we're up $2.6 million in sales. That is, as I have repeatedly talked about during the year, it's important to look at the inventory and where we were very low in inventory in Q2 and even lower in Q3 here in the fourth quarter, it's more gone back to where we started the year, even though it didn't get up to exactly the same level as last year. But still, we saw some buildup at the wholesalers. But we also saw some quite stable demand in the quarter. There was a little decline in one segment, but in -- where we've seen most of our loss in volume has been in the previously exclusive agreements with Humana and United, and that actually stabilized over the quarter. So we didn't see any decline a bit from Q3. We're also leaving with Dexcel, absolutely stellar reimbursement in this very competitive environment with nearly 100% access in the commercial segment, nearly 50% in the public segment, and that is what Dexcel will enter 2026 with. Orexo's market access team will continue -- some of them have left to Dexcel and some are still with Orexo, but we will continue to support Dexcel at least in the start of this year. Our entire sales force, as you know, have moved over. So we're quite pleased with that. And also something that we worked a lot on, and I think was important also for Dexcel is how we work to improve long-term cost of goods. So despite having inflationary pressure, we have been able to actually lower the expenses to produce ZUBSOLV tablet. And we're looking to have even lower cost of goods in the future, which is a very important part for Dexcel and a process between signing and closing was to ensure that these manufacturing partnerships that Orexo have set up would continue to support ZUBSOLV when it is moving to Dexcel. With that, I'm leaving the word to Fredrik to go through the technical aspects from the -- of the transaction.

Thank you, Nikolaj. So starting with some further details on the transaction. [ All in USD ], closed the transaction of ZUBSOLV U.S. business with an agreed purchase price of USD 91 million, approximately SEK 847 million. So that was paid at closing, plus the payment for value of inventory, both in Sweden and in the U.S. of a total of USD 3.8 million. Then USD 3 million was paid into an escrow account, and that is to cover our obligations for the coming 18 months after the closing, primarily in relation to returns of products sold by Orexo prior to closing. We're also entitled to an earn-out consisting of 2 payments of in total up to USD 16.8 million based on actual future ZUBSOLV net sales, both in 2026 and in 2027. So in the accounts, we have a risk-adjusted discounted estimate of the earn-outs of in total USD 8.2 million, and that is booked as a receivable. Other consequences of the transaction, as we talked about, we will be reimbursed for transition services provided to Dexcel for up to 18 months after closing. Services include finance, commercial, supply, quality, pharmacovigilance and regulatory services. And then on the corporate bond, post transaction, we will not be able to comply with the covenants in the maintenance as set out in the bond terms, which will trigger a redemption of all outstanding bonds at a set call price. And depending on decision by the Board, we expect this to happen end of Q1. Affecting the profits on the sale of ZUBSOLV, we also have additional provisions at year-end for returns and rebates to secure our obligations in relation to products sold by Dexcel prior to closing, and that's USD 7.9 million in total. So looking at what we ended up with as net proceeds in our accounts on the closing date. We will pay the purchase price of $91 million plus the inventory and then $3 million put into escrow account as deducted from net proceeds. So this ended up in an agreed purchase price of USD 91.8 million or SEK 854.5 million to be specific. And to get to the net proceeds, we also deduct transaction costs of SEK 41 million, resulting in net proceeds at closing of SEK 814 million. Now post-closing, there will be restructuring costs of operations, and this is planned to be completed by the end of the transition period. And the main part of those costs will be accounted for in Q1, but expenses will also occur during the remaining part of the transition period. And to summarize the major financial effects of the transaction, we received a significant cash inflow ended up in a cash situation of SEK 912 million at year-end and also restored group's shareholder equity of SEK 491 million. So moving to the next page where we have the P&L for continued operations. So obviously, that is the remaining part of U.S. commercial ex ZUBSOLV, as well as HQ pipeline. So on net revenues, SEK 3.3 million for the quarter. We do have lower Abstral royalties following the trend we seen as individual countries royalty agreements expire. Total lower Edluar royalties, mainly due this quarter to lower partner sales in Canada. ZUBSOLV ex-U.S. revenues were also lower, mainly explained by absence of tablet sales to Accord ahead of them starting manufacturing in Europe. On operating expenses, they reflect the cost base as of transaction, including costs expected to decrease once the organization and facilities have been aligned to meet our future requirements. They also include the resources needed to support Dexcel during the transition period. So OpEx amounted to SEK 104 million for the quarter. However, that is not comparable year-over-year unless you adjust 2024 OpEx with the impairment of intangible assets, Deprexis and Vorvida that we did last year, SEK 99 million. We also had an impairment this quarter. That is the remaining intangible assets, MODIA. The impairment was SEK 22 million, and this was allocated to admin expenses and R&D. Otherwise, selling expenses lower, partly due to weaker U.S. dollars, but also from lower marketing-related costs for IZIPRY. Admin also lower, mainly from reduced legal fees for the DOJ investigation and generally lower spending in HQ pipeline. In other OpEx there was a lower positive contribution from lower insurance reimbursement and lower partner related income, although we have the first invoice sent to BARDA for the 3 OX390 projects. Started up slowly towards the end of 2024 -- 2025, sorry, but it's expected to pick up with the cost coverage we get from BARDA as development efforts intensifies in 2026. EBITDA for continued operation negative for the quarter and by SEK 70 million. Discontinued operations, which then is presented in a note in the report, P&L shows lower ZUBSOLV U.S. sales in SEK due to lower demand and weaker U.S. dollars, partly offset by significantly higher wholesale stocking, local currency, as Nikolaj mentioned, we had higher sales at USD 14.6 million compared to USD 14.1 million last year. OpEx, obviously, reflect associated cost of selling ZUBSOLV products in the U.S. The main cost is then selling expenses, which is the sales force and sales support, which is now with Dexcel. But the main contributor to net earnings from discontinued operations of SEK 840 million is, of course, the profit on the sale of ZUBSOLV U.S. business, which amounted to SEK 769 million. And that profit is calculated from agreed purchase price, adding the market value of the estimated earn-out and then subtracting the book value of inventory sold, transaction costs, but also provisions, returns, and rebates. Move to the next page, cash flow. We reported a negative cash flow in Q4 of SEK 19 million for continued operations, mainly due to negative contribution from operating activities. But we did have a positive effect from financing activities, including a sale of SEK 10 million of our own bond. But of course, we reported significant positive cash flow from discontinued operations of SEK 830 million following the sale of ZUBSOLV business. Net proceeds, as we talked about, SEK 840 million and the rest being cash flow from ZUBSOLV operating activities. So after adjusting for a negative FX effect of SEK 4.3 million, that meant an increase in cash and cash equivalents since Q3 of SEK 807 million to SEK 912 million. And now we have -- instead of a net debt, we have a net cash of SEK 429.2 million. Okay. Final page for me. On next page, we show the outcome of our financial outlook for 2025. So we have adjusted the relevant metrics, so they exclude all effects of the ZUBSOLV transaction, and that's in order for us to be able to evaluate the outcome versus what we put up as metrics for 2025. So we can conclude that we met all the metrics for 2025. The buprenorphine-naloxone market grew 3% in 2025. We reached ZUBSOLV net sales of USD 51 million and adjusting also for the non-recurring rebate payment that we had in Q2, net sales was approximately USD 62 million. And OpEx, excluding depreciation, came in at the lower part of the range at SEK 468 million. Finally, EBITDA positive for the full year with SEK 3.2 million. Thanks. Back to you.

Thank you, Fredrik. So we also want just to remind everyone that we still have the Department of Justice investigation and the subpoena issued all the way back in 2020. Of course, the situation now is a different Orexo. Our money right now are going to be invested in developing new life-saving products, and that's something we, of course, will introduce into the discussion with the authorities in the U.S. I would say it's important to say that the investigation is not following the product. It is related to the company and the company staff. So I think, and I hope that I just saw yesterday, for example, that the current administration and the White House came out with a new executive order talking about how they need to improve treatment and bring new therapies into the market for opioid addiction and that crisis. And we are the only company who are working actively with a new product for the combination or the adulterated opioids also called tranq in the U.S. that right now is the fastest-growing issue in that market in terms of overdose and potential death. So I hope that we can have a constructive dialogue with the U.S. authorities. It has been a little difficult during last year because some of the turmoil that have been in the Department of Justice with new prosecutors appointed and the like. But hopefully, we can get some kind of resolution. That's the ambition for this process during the year. Very short as a roundup. So where do we expect is going to drive profit and growth for our shareholders in the future? We are working significantly to create a new pipeline of profit-generating projects. So basically drive our projects to the right time where we will then receive upfront payments, milestones, some cost sharing maybe in development if the product is not approved and also royalty after commercialization. We're looking at partnership where we reduce risk by getting cost coverage by partners. And also in the end, when the product are then launched, we will take a royalty on the basis of the long IP that we can contribute with. And then I think it's important also when we look at risk to decrease risk in our pipeline, also to expand our collaborations with industry experts in academia, and that's something we've done for both the GLP-1 agonist, semaglutide, where we're working with some industry experts and also in vaccines where we have some both academia and industry experts coming in as adviser. We then have to work on our science base, creating scientific proof points, reaching the time when we can have value inflection. And the ones that are closest now, we believe, are OX390 in-vivo data showing that we actually have a product that can work -- that works with a nasal delivery of the product. 640, really important project to show bioavailability in allergic patients on the nasal allergy challenge scheduled to start in Q4, IZIPRY, resubmission in Q3. And then, of course, that we -- as we expand our exploratory projects in GLP-1 and in vaccines that we can show relevant in-vivo data that this actually works. So that's something you can expect and should look for during this year. Then we need to look at the situation we have right now in the organization, ensuring we have the right competencies to support our strategic focus, and this is a process that is ongoing right now. But we also need to ensure that we are downsizing where we don't need expenses, and we are adjusting our fixed expenses. And one example there is both of the Swedish and the U.S. operations will move to a more fit-for-purpose and cheaper location during this year. So overall, I think there's a lot of work that we need to do across the company that we can optimize and reduce expenses and make it a little easier to work compared to being in the commercial stage we were in before. Finally, I'll just remind that we are now -- we have sent out a save the date for an Orexo R&D date where we will have guest speakers, we will have our colleagues from the U.S., and we will talk a little more into the details of our pipeline work, and that is scheduled for March 24, and the detailed agenda will come out a little later. With that, I will open up for questions and answers.

[Operator Instructions] The next question comes from Klas Palin from DNB Carnegie.

The first one is related to the balance sheet items. And if you could just help me out a little bit about the current assets and liabilities, you have quite significant receivables outstanding, and you also have account payables provisions. If you just could help me out what to expect from this going forward?

Yes. So we did an asset sale, and that we still have the balance sheet reflecting the assets prior to closing. So the balance sheet shows, obviously, accounts receivables and accounts payables and provisions all related to what has happened before closing. And that will sort of ease out of the balance sheet, if you will, as time passes here. So I mean, we believe that we have the correct provisions to cover all the obligations according to the purchase agreement. And then we have what we have in accounts receivables and payables.

I think the accounts receivables -- it's basically most of the products that we sold during Q4 have not been paid for yet. So we're looking at, I think, 45 average payment terms. So I mean most of the inventory buildup were in the last month, so that will complete during the quarter. The earn-out is in the receivables also. So that's in there. And the rebate payments, again, rebate payments for most of all of Q4 are not being paid. So they will come now in this quarter. We also have, of course, some rebate payments as we talked about before, some of them come very late. So we are making best of provisions for the rebate payments again for products sold before. Since there was a build-up also in the inventory, we agreed with Dexcel that we will pay some of the rebates for January because most of the products sold in January will be from Orexo. And then over time, there is a kind of our products have a 5-year shelf life. So there will be returns associated with the products basically for the lifetime of the product, then we expect that to decline over time. But of course, that can -- that will be products, and we can quite easily follow what product has been sold before December 31 and what product has been sold after December 31. So that's why you also see the provisions, and there, we have taken a relatively conservative approach to rather make a provision today than being surprised by unexpected payments a little later in the process.

And then just when it comes to the continued business that you're reporting and especially the R&D expenses for 2025, how should we think about these R&D expenses for 2026? Is it possible to give some sort of guidance?

I think just -- it's an interesting question, and we have discussed that a lot internally because we normally have a decent guidance on our expenses. The thing is, our fixed expenses, salaries and facilities is not particularly high. And of course, it's costs having 55 people in Sweden. But it's -- the big cost driver is really associated when we decide to run a clinical trial or when are we upscaling our commercial manufacturing. So it's triggered by that kind of events and we will look into how we're going to face that. And now when we have passed the transaction, which has changed the conditions, it now is possible for us to make a much more accelerated approach to our development than it was before the 31st of December. And I must admit that we have not done that time line and planning, but we'll have a discussion internally how we can guide in some shape or form moving forward. But it won't be an exact guidance because a lot of it is really depending on are we starting a clinical trial that is going to make a big difference if it's coming in Q4 or if it's coming in Q1. Right now, the plan is to run one clinical trial in Q4, which is going to some money. So I will have to come back on that, Klas.

And then just the last question, maybe you -- I missed this out. But did you say when you expect an approval of the new manufacturing process for Europe?

So this is sitting with Accord, and I believe we're expecting it now during the early spring.

The next question comes from Samir Devani from Rx Securities.

I'm not sure where to start. Maybe IZIPRY, when you did the deal with Dexcel, did you have any discussion about them potentially having a license to IZIPRY or any of your other opioid use disorder programs?

We did have a discussion with Dexcel and also with other companies. There were other companies that were more keen on IZIPRY, but they wanted that together with ZUBSOLV. And the value of the 2 combined was not competitive with Dexcel's offer. But Dexcel, in turn, I think, they wanted to have a foundation in their sales where they can add some of their own branded products. And I know that they're also looking to strengthen the commercial portfolio. And I think that when they looked at the target for IZIPRY, it wasn't matching the pipeline of projects that they have. So they decided not to move on IZIPRY.

Okay. And so then obviously, you've updated the sort of timeline for FDA refile. What would be your best guess now in terms of partnering IZIPRY? Is this going to be, you think, an event this year or maybe next year now?

We will start the process now when we -- I think we will -- just to avoid any further surprises, we will want to see that we have all the data needed for FDA in the autumn, and then we will intensify the efforts to see what we can do with IZIPRY. And that will be a big focus on the U.S. market. So the approval is expected. It depends a little on FDA, of course, but the approval is now expected in early 2027, and that's, of course, also would be perfect to have a partner in place at that time.

And just going back to the guidance, and I hear what you're saying about the difficulty in predicting clinical trial start-ups. But I think I just want to confirm that I think previously, you talked about post the Dexcel deal, you've got a runway of at least 2 years. Is that still the case in your current thinking? And also, you mentioned 55 people now in Sweden post the deal. How many are remaining in the U.S. office?

Long term in the U.S., it's going to be a handful of people. So 5 people is the ambition. And then in Sweden, we will see in Sweden, it depends a little on the -- so we're using a lot of consultants, and it depends on kind of we -- I could rather want to have employees, but then we need to see that there's a continuous workload that motivates that. So we would also in Sweden need to look at the mix of competencies, so there could be a need for strengthening up some areas and then maybe other areas, we would have less need for the current resources, and we're looking at that. And if you look at the runway, I think it's -- we have -- right now, we are well capitalized, and we have the money needed to run the current projects unless something else happens. So it's really about a prioritization. Do we want to run -- if we are taking one more project in, then we need -- we will have a shorter run rate. If we are taking in a partner in an earlier stage, which is the ambition for our development programs, then we will have a longer runway. Of course, it could be indefinite depending on what kind of partnership that we could end up with. So the ambition is, of course, during the next 2 years is to partner and get both more cost coverage in our existing capacity, but also with the projects we have to get someone in and support the development program with rights to one or more regions. But if you just take no other income, no other deals coming in, and then I think you -- and no other unexpected surprises, I think your runway is probably accurate.

And then maybe just one final question, just maybe for Fredrik on the -- you mentioned about there was still some restructuring costs to be borne in 2026. I'm assuming -- are these outside the provisions you've already taken? Or maybe just help me just what would be the cash restructuring costs this year?

So going forward, we obviously have these restructuring costs. We expect them to -- for the whole transition period basically. But we -- and I mentioned that we will have some or maybe the main part of them already in Q1 related to the organization of facilities in the U.S. mostly. But then those will sort of come during basically the whole transition period other than that Q1.

I think, Samir, one of the things or another thing is sort of, we closed the deal on December 31, and I can tell you on December 22 it was not -- I wouldn't have betted that we could make it until December 31. So it was a lot of work in the last week of the year. But that also meant that when we actually did the first wave of adjusting the organization in the U.S. that was communicated now during January and the first wave of colleagues in the U.S. have left the company by end of January. There will be some leaving also here in February. And of course, those expenses will be -- we will take provisions for those restructuring expenses when they come, and therefore, they come in Q1 rather than being together with the transaction. Thank you. Let me see if we have any written questions. We have -- we have a question here around whether we have any ongoing partner discussions for OX640. Do you see any interest from companies to be the seller of IZIPRY? So 640, we do have a discussion that some of the companies that we discussed it before was quite concerned about our financial capabilities to ensure we could support the full development program with the deal with ZUBSOLV that is helping. I also think the market for neffy, at least the latest data we saw was in Q3, was positive. In the U.S., we have seen one competitor, actually now was delayed. It wasn't a film. We got a CRL just in the week we have. So I think the competitive situation is probably looking somewhat better. And there are -- none of the partners that we have had in discussions, except for one, because they went another way, have gone. So I think there are opportunities to go back. But I also think from an Orexo perspective, there's a lot of value for us to take this one more step because we're taking away a lot of uncertainty. The clinical trial that we're doing now will be the first on commercially manufactured product. It will be the first with the final formulation also. So there's, of course, a value and exponential value add of getting more data and the proof-of-concept, which many other companies, and significantly bigger companies than those we have discussed specifically with, would want to see that we have more final clinical data, which is what we will get with the study in Q4. So there's a balancing act here, but there is some interest definitely. And for IZIPRY, I think it's -- we'll see that market has been in a lot of dynamics. But of course, again, with just the recent announcement from the White House, I believe that was yesterday, about the need for strengthening the efforts to address the consequences of the opioid addiction. I think there is a strong need for IZIPRY. It will be one of the strongest alternatives to reverse overdose with fentanyl. And I think it deserves a spot in the market, even though there are some lower dose and less strong alternatives in the market. But that one, we haven't really done any partnering with during this year because we want to be sure we have a timeline that works out, and we want to see that we can deliver on the reliability data asked from the FDA, which we feel quite comfortable with, but IZIPRY has unfortunately been delayed a couple of times. So now we want to get a little more certainty. And I can see with that I will close the Q&A. And thank you for your attention and look forward to talk to you again in about a quarter's time, if not before that. Thank you.

There are no more questions at this time. So I hand the conference back to the speakers for any closing comments.

Thank you and goodbye.