Orexo AB

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 5 on their telephone keypad. 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 Nikolai Sorensen, and I'm here together with Today we're going to go through our fourth quarter and the end result. 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 SoftSol. So we will have a lot of focus on the transaction and the implications on the organization and the same for the financials. Financials have a significant impact from this transaction, of course, but also the way that the financials are structured 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 Frederick 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 Dexelfarmer on the 31st of December. We closed the deal on the 31st of December after signing it on the 23rd of December. So, as you can understand, a lot of activities happened over Christmas for many of the employees in the leading positions in Orexo, both in the US 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 those 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 OREXA 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 OREX 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 that which is more like a concept than individual, because for every molecule there will be some unique features, different exceptions, 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. And we'll come back to that a little later. I will also say the Dexcel agreement closed on December 31st, 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 Rexel will continue to support Dexcel with certain functions and expertise to help them taking over and ensure we have uninterrupted supply of subsoil to the market in the US. So we have a tight and daily relationship with the Dexcel leadership. For R&D, we're starting to talk about three different categories. Here we highlight two on this summary. It's what we call exploratory research. That's when we are working to see new application areas for our MorphX platform where we think there could be significant opportunities moving forward. As you know, we announced during the autumn that we're working with Summit BlueSide. But we're also working in vaccines, where we have worked a lot with Apera, 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 Rexel projects. We have a pivotal trial for 640. We are now planning that for Q4 this year, for 390. We're working a lot with our and that is to prepare for the first in vivo proof of concept study, which is going to start in this quarter. And in ICIPRI, we are making good progress towards the plan 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 $912 million left. Swedish Krona on the bank account, which is a little increase from last, the 31st of December, 2024. So, about the soft-sold transaction. As you know, it was acquired by Dexel Pharma. Dexel is the largest privately held pharma company in Israel, but they are now expanding heavily into the US market. They have some branded, but a lot of generic products in the US, and they were highly interested in acquiring a full field force that would be able for them to build that 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 Dexa. That enabled us to close the deal on December 31st and 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 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 Edloa, Avstral, Subsolid Europe, and now also Subsolid US. And that means that in Sweden, that's basically all of the staff in Sweden from R&D, business development, and headquarter. In the US, 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 BARA. And we also have, we will change some commercial resources in the U.S., 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 retain some resources, and this is important because if you look at the OPEX for the continued operation, that actually includes all of the transition resources that are all of the expenses associated with them for 25 is included in the continued operations, and they will continue at a at a certain period of time to support the transition. And that's open in finance, market access, supply distribution, regulatory support, for example, when in ramps or across safety. All of these services are reimbursed to some extent by the Excel. And the plan is when Dexcel build up their own capabilities, the support from Rexel will decline and then we will restructure our organization accordingly and stepwise following the timeline 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 us long-term. Discontinued operations, on the other hand, that's basically what has left the company. And that's the feed force from an OPEX, because of course all revenue is associated with SubSol, 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 sub-solid sales efforts. The timeline, 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 say we're already moving towards that the new orexo we say march here but that's where we're planning to do some of the more we have our r d day where we 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 amorphous 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're looking at this in three 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 decides 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's a big value inflection where it's time to get in partners. And the third area is partnering the amorphous technology, basically making the technology available for other companies who can benefit from the amorphous technology and where OREXA will then support them during their development. Moving a little into more details of that. So in the exploring phase, we are basically looking at areas where we can move from incremental improvements, 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 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 why we're focusing now is simply to test how do we apply amorphic 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 ELP1 agonists, and in particular, semaglutide, where we continue to work on the formulation where some Brilliant ideas, I hope, for how we can improve the bioavailability even further. So making it a really competitive alternative in this space. And this is something that we're 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 Avera, a small Swedish company. But with the resources we have now, we have retained or have created collaborations with research partners who are active in academia, both in Sweden and the US, to advise us and also to work on 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 be really interesting opportunities moving forward. The next area is our own projects, or what we call proprietary projects. And that's where O-Rex will 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 the regulatory authorities. We have a dedicated team and a timeline for the projects. And the focus here at the moment are well-known projects to all of you, I believe. It's OH640, where we're now. The first pivotal clinical trial is the 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. I agree. 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 US. 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 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, where the amorphous technology can support their development. Here, again, we have worked. for example, with a bureau that we think we can support. Some of you have been with us earlier and know that we did have a project with SOPI. We have other or several others that are non-disclosed 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 utilizations for our facilities, and learn more about how we can expand the use of the amorphous 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 Morphox technology projects, the partner will cover most of the expenses with some marketing director, 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 four revenue-generating partnerships. As you know, none of them are based on the Morphox, but they are still generating revenues for us. So, SubSol US, we have an earn-out. Frederick could talk more about that. SubSol Europe, it's been a little slow during this year, but that's because Accord have built up 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. Avstral and Edlois are both lagging towards the end of the contract in several markets and also with the patterns which is reflected in the declined revenues that Frederik 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 Avstral's. More to leave it. But we're pretty pleased with the development in the fourth quarter. In the US dollars, sales actually grew in the quarter. So we have 14.6 compared to 14.1 last year. If we're also looking at last quarter, we were 12 and now we're up 2.6 million dollars in sales. That is, as I have repeatedly talked about during the year, it's important to look at the inventory And while 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 build-up of the wholesalers. But we also saw some quite stable demand in the quarter. There was a little decline in one segment, but 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 quarters. We didn't see any decline from Q3. We are also leaving with Dexel an 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 Dexel will enter 2026 with. Rexel's market access team will continue. Some of them have left to Dexel and some are still with Rexel, but will continue to support Dexel at least in the start of this year. Our entire sales forces, 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 the Excel 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 for produced soft-solid tablets. 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 Orex have set up would continue to support soft-solid when it is moving to Dexcel. With that, I'm leaving the word to Frederik to go through the technical aspects of the transaction.

Thank you, Niklas. So, starting with some further details on the transaction. On New Year's Eve, closed transaction of a sub-sale US business with an aggregate purchase price of 91 million US dollars, approximately 847 million SEK. 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 3.8 million U.S. dollars. Then 3 million U.S. dollars 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 earner. consisting of two payments of in total up to 16.8 million US dollars, based on actual future sub-sale 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 8.2 million US dollars. And that is both as a receivable Other consequences of the transaction, as we talked about, we will be reimbursed for transition services provided the DEXO 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 test as set out in the bond terms, which will trigger a redemption of all outstanding bonds at a set core price. Depending on decision by the board, we expect this to happen end of Q1. Affecting the profit on the sale of sub-sale, we also have additional provisions at year-end for returns and rebates to secure our obligations in relation to products sold by Rexel prior to closing. And that's 7.9 million US dollars. So, look at what we ended up with as net proceeds in our accounts on the closing day. we will pay the purchase price of $91 million, plus the inventory, and then $3 million put into the escrow account as a deducted from net proceeds. So this ended up in an agreed purchase price of $91.8 billion, or 854.5, to be specific, million SEK. And to get to the net proceeds, we also deduct transaction costs of 41 million SEC, resulting in net proceeds at closing of 814 million SEC. Now, post-closing, there will be first 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 912 million SEK at year end, and also restored the group's shareholder equity of 491 million SEK. So moving to the next page where we have the P&L for continued operations. So obviously that is the remaining part of the U.S. commercial, XSO, as well as HQ pipeline. So on net revenues, 3.3 million SEK for the quarter. We do have lower outside royalties following the trend we've seen as individual countries' royalty agreements expire. Both have lower Eduardo royalties, mainly due this quarter to lower partner sales in Canada. Some of 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 Excel during the transition period. So OPEX amounted to 104 million SEK for the quarter. However, that is not comparable year over year, unless you adjust 2024 OPEX with the impairment of intangible assets, the praxis and verbida that we did last year, 99 million SEK. We also had an impairment this quarter. That is the remaining intangible assets, MoDiA. The impairment was 22 million SEK, and this was allocated to admin expenses and R&D. Otherwise, selling expenses lower, partly due to weak US dollars, but also from lower marketing-related costs for IC3. Admin also lower, mainly from reduced legal fees for the DUJ investigation, and generally lower spending in the HQ pipeline. In other OPEX, there was a lower positive contribution from lower insurance reimbursement, and the lower partner-related income, although we had the first invoice sent to BARDA for the OS 390 project. Started off slowly towards the end of 2025, but is 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 by 70 billion SEK. Discontinued operations, which then is presented in a note in the report. DNL shows lower stocks for U.S. sales in SEC due to lower demand and weaker U.S. dollars. Partial set by significantly higher wholesale stocking. Low concurrency, as Nikolai mentioned. We had higher sales, U.S. dollar 14.6 million compared to 14.5 last year. OPEX obviously reflects associated costs of selling self-sale products in the U.S. The main cost is then selling expenses, which is the sales force and sales support, which is now with Dexel. But the main contributor to net earnings from discontinued operations of 840 million is, of course, the profit on the sales and self-sale U.S. business. which amounted to 769 million SEK. And that profit is calculated from agreed purchase price, adding the market value of the estimated earnout, and then subtracting the book value of inventory sold, transaction costs, but also provisions for returns and repays. Move to the next page, cash flow. We reported a negative cash flow in Q4. Or a $19 million set for continued operations may be due to negative contribution from operating activities. But we did have a positive effect from financing activities, including a sale of $10 million of our own bond. But, of course, we reported significant positive cash flow from discontinued operations of 830 million SEK following the sale of South Coral Business. Net proceed, as we talked about, 840 million and the rest being cash flow from South-South operating activities. So after adjusting for negative FX effect of 4.3 million, that meant an increase in cash and cash equivalents in Q3 of 807 million to 912 million SEK. And now we have, instead of a net bet, we have a net cash of 429.2 million SEK. 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 subsoil count action. 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 proper north-in Madison market gave 3% in 2025. We reached south-south net sales of $51 million, and adjusting also for the non-recurring rebate payment that we had in Q2, net sales was approximately $62 million. And OPEX, excluding depreciation, came in at the lower part of the range at $468 million. Finally, EBITDA, positive for the full year with 3.2 million. Thanks. Back to you. Thank you, Frederik.