Welcome to this first quarter presentation of Orexo’s results. Together with me today, I have Fredrik Järrsten, CFO of Orexo, and I am Nikolaj Sørensen, CEO of Orexo.

This quarter is the first quarter where we are presenting without Zubsolv, which we divested on the last day of 2025. Of course, the Zubsolv divestment has had a significant impact on the quarter and has also taken a lot of focus in the organization.

The Zubsolv sale was concluded on New Year’s Eve 2025, but during this quarter we have been cleaning up our balance sheet, restructuring the organization and paying quite a few transaction-related fees and costs. That had a significant impact on the cash position in the quarter and, of course, also on the result of the company in the quarter. By far the biggest item was the repayment of the corporate bond, which was SEK 500 million plus interest.

I would say the Zubsolv transition has been running very smoothly. There has been fantastic engagement both from colleagues who are leaving the company and colleagues who are staying with the company, to ensure that the transition to Dexel has been running as smoothly as possible and to avoid any interruption in the availability of Zubsolv for patients in the US.

Looking at the sales development for Dexel, it is looking promising for the first quarter. That is, of course, important for Orexo because we are receiving an earnout based on sales during this year. The earnout will be paid out early next year. At the moment, we are on track to meet the threshold for the earnout, and it is looking good from a Dexel perspective.

The money that we receive from the sale of Zubsolv is important because it enables us to continue to invest in our development programs, our R&D programs and our larger development programs. I am pleased to report that they are all making steady progress against the milestones and timelines that we have shared previously.

We are expanding our use of AmorphOX into new areas, in particular in GLP-1 agonists and semaglutide, and into vaccines. During the quarter, we have also moved semaglutide into an oral formulation based on feedback we received from the market and from experts who believe that our technology could have a positive impact on the bioavailability of GLP-1 agonists such as semaglutide.

If you look at the way we are going to present the company moving forward, we are looking at our R&D work in three different segments. The first is Explore, where we test the boundaries of the AmorphOX technology in new areas where we see potential future value creation. Such areas today are in the GLP-1 agonist space and in vaccines, where we think our technology is well suited to add value.

The second segment is Develop. That is when we have a set timeline towards submission of the programs to regulatory authorities. That is when we have planned clinical trials and where we are investing most of our resources.

The third segment is Partner. That is when we are looking to make AmorphOX available for other companies that want to develop a certain project and where they see that the unique parameters and advantages of AmorphOX can help them with their proprietary projects.

Going into the first area, Explore, we have been working with semaglutide and have some promising data in nasal application, but we have continued to expand into oral semaglutide delivery based on feedback from the market. We are planning to run a first preclinical in vivo proof-of-concept study in the second half of this year, and we have continued to expand our patent portfolio around the semaglutide space.

You could ask whether we are now diverting into another area, but it is actually quite related. When working with a peptide like semaglutide, the way we can use our particles from AmorphOX and include other excipients together with the active ingredient is something that is similar for oral and nasal delivery. This is a way for us to improve our understanding of how we can work with AmorphOX in the peptide space. We continue to work with both oral and nasal delivery.

In vaccines, we have worked with Abera, as you know, but during the quarter we have also tried to expand into new types of vaccines. We hope to soon have both industrial and academic partners where we can test other types of vaccines together with AmorphOX, again to explore the boundaries of the technology.

For our proprietary and development programs, this is where we have most of our resources tied up, both in terms of people and money. For OX124, we are still on track to resubmit the OX124 file to the FDA during the summer, in Q3. For OX640, during this quarter we have really focused on upscaling our manufacturing and ensuring that our contract manufacturing partner is ready to do commercial-scale manufacturing of OX640.

Here, we are leveraging the manufacturing setup that we have for OX124. So we have significant synergy between OX640 and OX124. But we do need to manufacture OX640 for the pivotal trial to ensure we are using what we call commercially manufactured product in that pivotal trial, which is scheduled to start at the end of this year.

During the quarter, we have also been working on what we call formative human factors studies. That is when we test whether our instructions for use and the device can be used by patients in the right way. This was very successful and gave us good confidence that we are ready to move into the final human factors study that we need for submission to the FDA when Orexo finds the right time.

It is not on the critical timeline, but doing the formal human factors studies is important because in the nasal allergy challenge study that we are doing, we need to use commercially manufactured product with something close to the final product in terms of instructions for use as well.

Finally, we are running our first in vivo study with OX390, where the active ingredient is adenosine. We have started to test the nasal availability of the formulations we have with OX390, and we expect to have a readout during this quarter, meaning Q2.

In addition, we are planning a Type C meeting with the FDA, and we are working closely with BARDA in the preparations and execution of this meeting. We are convinced, based on feedback from the US administration, both from the Department of Health and Human Services and other parts of the US administration, that OX390 is a highly prioritized project for the US government.

We are, of course, optimistic that we can find ways together with different authorities, including the FDA, to ensure that we have as fast a development program as possible for OX390, which is addressing a huge unmet need in the US market at the moment.

Looking at the final segment, Partner, this is where we are testing our technology together with other companies on their products or technologies. As you know, we have been running several feasibility studies, and what we really need to do is to move this up to larger partnering programs.

We are in dialogue with several different companies. We are running some smaller feasibility studies at the moment. Of course, the real value generation comes when these partnerships turn into real partnership agreements, or agreements where the partner will cover some of Orexo’s expenses. This is an area where we think we can step up and improve significantly during the year.

With this, I will leave the word to Fredrik to go through the financials.

Thank you, Nikolaj. Starting with the P&L for continued operations, following the divestment of Zubsolv US, we as of this quarter no longer follow up on a segment basis. The divested Zubsolv US business is presented as discontinued operations in Note 10 in the report.

Net revenues were SEK 5 million for the quarter. We had lower Abstral royalties, following the trend we have seen for a while now as individual countries’ royalty agreements expire. We had higher Edluar royalties from higher sales in Canada, and we had lower Zubsolv ex-US revenues, explained by the absence of tablet sales to Accord ahead of them finalizing their Zubsolv manufacturing setup in Europe.

OpEx amounted to SEK 80 million for the quarter, down SEK 5 million from Q1 last year. Selling expenses were minimal this quarter and lower than last year, mainly due to lower marketing-related costs for OX124 and lower DMHP activities. Admin costs were higher, mainly due to increased legal fees related to seeking a settlement in the DOJ investigation.

R&D costs were also higher following high costs for the development of OX640 and OX390, which on the other hand also meant higher BARDA reimbursements of OX390-related costs of in total SEK 7 million. That is the main reason for the total positive contribution from other operating income and expenses of SEK 8 million.

The increase in net financial items comes from higher bond loan costs following the early redemption of the corporate bond, which we completed on March 30. That was partly offset by higher interest income from our bank accounts.

Net profit for continued operations was negative SEK 105 million, and for discontinued operations negative SEK 29 million. That is mainly explained by restructuring costs post-transaction, the majority being severance pay to people who left or will leave Orexo as a result of the transaction.

Moving to the cash flow, we reported total negative cash flow in Q1 for continued operations of SEK 528 million, and the absolute majority of that is a consequence of the early redemption of the bond. During the quarter, Orexo exercised its right to carry out an early redemption of the outstanding bond at the nominal value of SEK 500 million, out of which Orexo owns SEK 10 million on its own account. The redemption had a negative impact of SEK 490 million on financing activities.

We also had a negative contribution from operating activities of SEK 33 million, primarily impacted by negative operating earnings and financial expenses related to the redemption of the bond. We also had a negative adjustment for non-cash items, where the major part was payment of provisions for outstanding rebates related to Zubsolv sales in 2025 and obligations in the Zubsolv agreement related to rebates.

Furthermore, we had positive changes in working capital from collected Zubsolv sales-related receivables from 2025. In addition, under the transition services agreement following the divestment, Orexo continues to collect Zubsolv revenues on behalf of Dexel during the first nine months of this year. That had a positive impact of SEK 52 million on working capital in Q1 and therefore on our cash. But this is just a pass-through and will be paid to Dexel.

Cash flow from continued operations was negative SEK 528 million, and cash flow from discontinued operations was negative SEK 7.5 million, mainly from payment of severance and other post-transaction-related restructuring costs. After adjusting for a positive FX effect of SEK 9.2 million, that meant a decrease in cash and cash equivalents of SEK 526 million to SEK 386 million, out of which SEK 52 million belongs to Dexel.

With that, back to you, Nikolaj.

Thank you, Fredrik. Lastly, a short update on the legal situation. As you know, we have had an ongoing process with the US Department of Justice since July 14, 2020, when we received a subpoena. Since we have no more commercial business in the US, we think it is a good time for us to settle this matter.

We are trying to navigate our way through the US Department of Justice, even though it is relatively volatile due to reorganization and lack of a permanent appointment of a US prosecutor in the district that we are working with. But we are optimistic that we can find a resolution, and we are working intensively with the matter, which you could see in some of the expenses in the first quarter, which were somewhat higher due to legal costs.

I will end with some of the value triggers that you can expect for Orexo, both short, medium and long term. Starting with Zubsolv Europe, as Fredrik talked about, Accord has been setting up its own manufacturing process in Europe to improve competitiveness from a pricing perspective. We expect them to start selling their own material relatively soon, and that should have a positive impact on sales in Europe, which will help us on a royalty basis.

A lot of the sales we have seen from Europe have been Orexo basically selling material to Accord at very little margin, if any. Now that we can hopefully see some positive development in Europe, that would also help the royalty we could earn from Zubsolv in Europe.

For the coming years, we are also expecting to receive an earnout from our Zubsolv sales, to be received early 2027 and early 2028, relating to sales in 2026 and 2027.

OX124 is expected to be filed with the FDA during the summer, and with that we would have approval early next year. For OX124, we are also looking for a commercial partner, which would be as important as the approval in the US since Orexo has no own commercial organization in place to lead the launch of OX124 in the US.

For OX640, we are putting the start of the pivotal trial here, even though the most important thing is of course the results that we are expecting early next year, as well as all of the work leading up to the pivotal trial. Since we are working with an emergency product in the US, which has very high standards for manufacturing, our ability to manufacture products in the right quality will be important for the start of the pivotal trial and also an important milestone both for Orexo and in our discussions with potential partners for OX640.

For OX390, the in vivo studies that we are waiting for will be the first test of nasal availability of OX390, and that is of course very important when developing a nasal product. It is an important trigger point both for the project and for the ability of the project to move into the next stages of BARDA financing, which is to be negotiated or released during the second half of next year.

For OX390, we also have the Type C meeting with the FDA, which is a continuous process, but every meeting with the FDA is an important process to potentially accelerate the development of the program.

Then we have our exploratory segment. As you know, we expect to run an in vivo study in semaglutide oral formulation during the second half. We also continue to work with our nasal formulation, and if successful, we can see some of the first human studies already next year. But all of that depends on promising data from the in vivo studies.

Finally, on all of the programs and all of our technology, we are continuously working on partnering. Partnering will be an important value trigger for the company when it happens. I know from experience that an agreement is only an agreement when it is signed by both parties, so we will of course announce when we have an agreement in place, but we cannot set a specific target date for when that will happen. We do have good dialogue both around our technology and around some of our development programs.

With that, I will open up for questions and answers. Thank you for your attention.

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. The next question comes from Klaas Pahlén from DNB Carnegie. Please go ahead.

Hello, and thank you for taking my questions, even though I want to mention that I did not hear much of the presentation. So excuse me if my questions have already been addressed. I wonder, how typical a quarter is Q1 2026 for the new Orexo if we exclude what you are doing with DOJ for the moment?

All right, so there are maybe different perspectives on that question, Claes. If I address it from a cost perspective, obviously we are in the transition period, and costs within discontinued operations are related to the transition. But also in continued operations, we are affected by additional costs in relation to the transition.

If we look at a normalized annual OpEx and deduct those extra costs, assuming also the projects that we are running now, an annual OpEx excluding depreciation would be around SEK 250 million. It is an estimate, Claes.

Yes, sure, that is fine. Could you also provide some granularity about DOJ? Of course, I do not know what you can say.

I would say we cannot say that much more right now. It is a difficult process, not least due to personnel changes at the DOJ and uncertainty about who is leading from their side. But we have an ongoing dialogue, and it is our clear ambition to try to close this. We are navigating our way through the Department of Justice to find a way to get to a settlement.

Okay, perfect. My last question: could you provide some timeline for when you think the phase-out will be completed of the divested business?

We expect the transition period to last some time after the first half of the year. I guess September or October would be a fair estimate. In that period, we will phase out, in continued operations, the people who are busy with the transition but then no longer needed. With the end of the transition period, for discontinued operations this year, there will be no costs or income in that. So that is a fair estimate, I would say.

Okay, great. Thank you for taking my questions. Sorry about the quality of the line.

So unfortunate. The next question comes from Sameer Devani from ARX Securities. Please go ahead.

Hi, guys. I have a couple of questions, really just again coming back to the transition and the SEK 52 million that is owed to Dexel. I am assuming that is for returns and rebates only. I wanted a bit more granularity. How much were the returns and rebates in Q1? Is that all for Q1, the SEK 52 million, or should we assume that will be paid in Q2? Is that correct?

There are different aspects to that as well. The SEK 52 million refers to Orexo collecting sales revenues from Zubsolv. Obviously, that is just a pass-through. So the SEK 52 million does not belong to us. That is the easy part.

In relation to rebates and returns, we started the quarter with SEK 155 million in provisions for rebates. A big part of that follows from separating an asset. We are to pay rebates for those assets that were there in 2025. We have also paid, following the purchase agreement, where we had commitments and provisions related to the agreement. That has been dealt with during Q1 to a large extent. Out of the SEK 155 million, we paid SEK 109 million in rebates, and that means that we still have some SEK 40 million in rebates left to pay going forward.

Okay, that is very helpful, Fredrik. But the SEK 52 million in Q2, will there still be pass-through payments coming, or will Dexel have taken it all over by then?

No, that will be taken over as we speak, but since this lasts for nine months, there will probably be new pass-through money to clear to Dexel.

Okay, fair enough. My only other question is on the BARDA collaboration. You mentioned that we are going to see some in vivo data in Q2. Is that a go/no-go point in the collaboration then? And if so, what do you need to show for the collaboration to progress?

I think in all development there is a continuous go/no-go. If things are turning out in a very unfortunate way, then you have to consider whether it is worth redoing. Should we redo the formulations? We are testing several different formulations in the in vivo study, and if for some reason all of them show no indication of nasal uptake, then there will need to be a new discussion with BARDA about how this is moving along.

I think that comes continuously in all development programs. This one is a little unique because we are running other programs, or have been running other programs, in these early stages without sharing the information. But because we have an income, we are of course giving continuous updates on the BARDA partnership.

What we are testing in the in vivo study is nasal uptake, and there has been some evidence that adenosine, the active ingredient, is available for uptake through the nose. So we think we have a good shot on goal here. But of course, should it turn out that there is no uptake, then there will need to be a new discussion with BARDA: is it worthwhile adjusting the formulation, are there other delivery methods that we should test, or should the program not continue?

But adenosine, as we discussed at the R&D Days, is well researched and has been tested and is used daily in veterinary use across the world. It is a well-documented API, just not for humans.

Okay, that is great. Thanks very much.

Thank you. We have a problem here, and I am really sorry about the sound. We recognized it when we got disconnected. We have a few comments about that, and my apologies. We need to go back and look at what we can do to address that next time and avoid the same thing happening.

We have a question about what the value triggers are in the near term. Delivering on our development program is of course what we have most control over, and basically meeting the development milestones that we have outlined now: in vivo data from OX390, which Sameer just asked about; our submission of OX124; the continued development towards starting the OX640 program in the autumn; I think those are all important data points.

Also, in vivo data on GLP-1s, should that turn out positive, would be an important trigger. On top of that, we of course have partnering discussions. From experience, I would say it is very hard to put a timeline on some of these processes, but it is not because they are not ongoing. Partnering discussions are ongoing on different types of development programs, and should they come in, I would expect that to have a positive impact.

As I said, we are running negotiations and discussions as we speak. We are of course optimistic that we will have some partnership that we can share, but time will tell. There is no deal until we have a signed agreement.

I also think it is quite important, if you look at the overall market, that there are external drivers that can have an impact. Taking OX640, I would look at the transition or transformation of the injectable epinephrine market and how it is moving into nasal. As you know, there are nasal alternatives available in Europe, in some countries in Europe, in the US, and it just got approval a few weeks ago in Canada. This transformation from injectable and auto-injectors into nasal is, I think, an important value trigger, since OX640 is relatively close by in development terms and is a late-stage, quite low-risk asset. Recognizing value in that will be an important value trigger.

With that, we have no further questions. Once again, my sincere apologies about the sound. I invite you to listen in to our future presentations. Information on when they are available can be found on the homepage. Thanks a lot and goodbye.