Swedish pharmaceutical company Orexo reported its third-quarter results for 2026 on October 22, describing a period of significant change. Having sold its flagship US drug Zubsolv to Dexcel Pharma at the end of 2025, the company is now rebuilding around its core drug delivery technology, AmorphOX — a powder-based system designed to help medicines work faster and more reliably in the body. CEO Nikolaj Sørensen summarised the company's direction plainly: the focus is now on developing and partnering its pipeline of emergency rescue medications and exploring new uses for AmorphOX in areas like diabetes treatments and vaccines.
Three pipeline milestones stood out during the quarter. The company resubmitted its application for Izipry — a high-dose nasal powder product designed to reverse opioid overdoses — to the US Food and Drug Administration (FDA, the American regulator that approves medicines) on September 29. The FDA also accepted the investigational new drug application for OX640, a nasal powder treatment for severe allergic reactions including anaphylaxis, clearing the way for a pivotal (late-stage, potentially approval-enabling) clinical trial to begin. Additionally, the US government agency BARDA (Biomedical Advanced Research and Development Authority) added 2.99 million US dollars in funding for OX390, an overdose reversal treatment, bringing the total contract value to 53.8 million US dollars.
Financial Performance
The numbers for this quarter reflect a company still in the middle of a painful but deliberate restructuring. Total net revenues — the money earned from royalties on licensed products — fell to 0.8 million Swedish kronor, down from 4.8 million Swedish kronor in the same quarter last year. The decline was mainly due to lower royalties from Abstral and Edluar (pain and sleep medicines licensed to other companies), while Zubsolv royalties outside the US held steady. Operating expenses (the day-to-day cost of running the business) came to 99.3 million Swedish kronor for the quarter. A notable one-time item within that figure was a provision of 34.6 million Swedish kronor set aside for the proposed settlement with the US Department of Justice (DOJ), relating to an investigation into historical marketing practices that has been ongoing since 2020. Under the proposed agreement, Orexo would pay 4 million US dollars in instalments over several years, plus a potential additional payment equal to five percent of net sales if certain thresholds are met in 2030 and 2031.
The overall net loss from continuing operations for the quarter was 117.9 million Swedish kronor, compared to a loss of 99.7 million Swedish kronor a year earlier. EBITDA (earnings before interest, taxes, depreciation, and amortisation — a measure of operating performance that strips out non-cash accounting charges) was negative 90.4 million Swedish kronor. Cash flow from operating activities was negative 118.1 million Swedish kronor for the quarter. Total cash at quarter-end stood at 152.6 million Swedish kronor; however, 90.5 million Swedish kronor of that relates to funds payable to Dexcel or held for rebate payments connected to the former Zubsolv business. Orexo's own freely available cash was therefore 62.1 million Swedish kronor. Earnings per share from continuing operations were negative 3.36 Swedish kronor, compared to negative 2.87 Swedish kronor in Q3 2025.
Forward Guidance
Management expects costs and cash outflows to decline meaningfully in the fourth quarter of 2026 and further into 2027, as one-time restructuring costs, DOJ-related legal fees, and legacy Zubsolv rebate payments fall away. A rights issue (a fundraising where existing shareholders are offered new shares) of approximately 250 million Swedish kronor was announced in early October, subject to shareholder approval on November 6, 2026; the issue is supported by subscription commitments and an underwriting guarantee totalling approximately 175 million Swedish kronor, corresponding to approximately 70 percent of the issue, with expected net proceeds of approximately 145 million Swedish kronor at that subscription level. Combined with the anticipated Zubsolv earn-out payment — expected in early 2027 and recently revised upward — management believes the company has sufficient funding to execute its business plan for at least the next 12 months. FDA approval for Izipry is expected in the first half of 2027, and pivotal trial results for OX640 are anticipated in early 2027.
Key Takeaways
Izipry is under FDA review, with a potential approval expected in the first half of 2027 — which would be Orexo's fifth product brought to market and a meaningful step toward attracting a US commercial partner.
OX640's pivotal trial is set to begin in Q4 2026, with results expected in early 2027; 12,000 commercial-scale units have been manufactured and are undergoing final quality testing.
The DOJ investigation is approaching resolution: a non-binding settlement in principle has been agreed, with Orexo expected to pay 4 million US dollars in instalments over several years — removing a six-year overhang on the company.
Reported losses are large but heavily influenced by one-time items: the DOJ provision, digital mental health business wind-down costs, and legacy Zubsolv rebates account for a significant portion of the quarter's cash outflow and are not expected to recur.
The rights issue and Zubsolv earn-out are the near-term financial lifelines: investors should watch for the November 6 shareholder vote on the rights issue and monitor Zubsolv US sales performance, as both directly affect how long Orexo can fund its pipeline without a partnership deal.
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.
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InvestorCaller Host: 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 answers session, participants are able to ask questions by dialing *5 on their telephone keypad. Now I will hand the conference over to the speakers. Please go ahead.
Nikolaj Sørensen (CEO): Good afternoon everyone, I'm Nikolaj Sørensen, I'm the CEO of Orexo and welcome to this Q3 interim report from Orexo. Together with me today I have Fredrik Järrsten, our CFO, and he will take us through some of the financial numbers in the presentation. So we label this quarterly report Orexo in Transformation and it has indeed been an intensive year from a a transformation perspective, and we start to see that we get into this new platform-focused company that we want to become and have made quite a lot of progress in our development plan during the quarter. And as you know, also announced a rights issue which will support us to take the company all the way through the transformation and pass some critical timelines in our development programs. Summary, a little of where we are and why do I claim that we have made important progress in our development programs is that we have— for Izipry, on the 29th of September, we resubmitted the file to FDA, and we expect a 6-month review time, which would take us into the end of first quarter, and we will have our next product approved in the US. On OX640, we had our IND accepted, which is— you say it's maybe feeling like a small step, but it's incredibly important because that is the one confirming our clinical trial program that we are going to follow through the development of OX640 and other data points that we need to collect. We have also started our manufacturing, and we have manufactured 12,000 units of OX640 in commercial scale. Come back to that a little later, but right now we're doing some testing before we can do the final release of these for the clinical trial. For OX390, the project we have together with BARDA, BARDA agreed to extend the initial development stage and also provide an additional $3 million to the overall funding. So on each of these 3 programs, we have made good progress. When we look at our other programs, we have just went out slightly after the quarter ended with our first in vivo study results from oral semaglutide. As you know, we have done it before in nasal. The numbers were encouraging. It was our first oral formulation, and we saw that we had comparable bioavailability as the reference tablet, which is a high bar being the first formulations that we're testing in oral formulation, and the reference tablet has been developed over several years or many years. On vaccines, we have a collaboration together with a well-renowned research institution in the US where we are applying for non-diluted grant funding to basically test AmorphOX platform on different vaccine projects. For Zubsolv in the US, we have in this quarter— it might pass some of you, but we every quarter we're reviewing our progress and see where we believe we will be with the earnout. And we, based on the current trajectory of Zubsolv sales in the US, which is progressing well, we have come up that we have to increase our provision with 21 million Swedish kronor. So we are increasing the amount that we expect to get paid in the earnout in early next year. We also announced that we have— we are very close to settlement. We have agreed in principle on the main terms with the Department of Justice. It's something that we've been forced into in about 6 years. It's taken a lot of effort, a lot of money also, to get to the point we are in right now. But I'm quite pleased that we actually can see that we're ending this process and we have reached this agreement in principle with Department of Justice, a very, very important cornerstone in this transformation we're entering into as a company. And then we have our rights issue that we announced recently and that we are now going to conclude during this quarter. The transformation that we are into, as you know, we sold the Zubsolv rights And what we're really trying to do now is we are restructuring our balance sheet. We're restructuring operations. We're streamlining operations. That means basically cutting costs in both Sweden and in particular in the US. As mentioned before, resolving the DOJ investigation are important. And now with the rights issue, we also feel that we have the financial flexibility that we need to take this company all through the transformation. And what we really want to do is to take our existing programs into a partnership and then start development programs together with other companies based on the AmorphOX platform. And we are making some decent progress in this space, which is basically a plan that we set up for, for the company when we took the decision to sell off the US business last year. When it comes to the right issues, it is something that will give us the flexibility to continue the development through critical milestones. We'll come to the financials later, and I can say the financial result that you looking at for this quarter has nothing to do with how the financials will look for the next year. We are now into the final stages of cleaning up the balance sheet and some of the payables we have from Zubsolv when we sold off Zubsolv also to streamline the US operations. And with the money we have now, we feel we will be in a good place to take the company through to this transformation where we sign partnerships and get partners to both co-finance and also fully finance development programs on the basis of the AmorphOX platform. Looking at how we are allocating the funds, we are seeing that OX640 remains one of the larger expenses. It was that for this year and also in this quarter. Then we have our OX390 Development where most of it is financed by BARDA, but Orexo still have to take some. But our continued project with semaglutide, another GLP-1 Agonist, we have in there vaccines. We are looking for non-dilutive financing, but we will need to take some expenses for that. Izipry, we said 10%. I think that's a high number because we are now we are basically done with the majority of the work, but with— as it is with any program, then we, for Izipry, we will need to continue monitoring shelf life and also reliability data. But that's a significantly lower cost than we have right now. And then we of course have the DOJ and general strengthening of our working capital. So what is the focus for the company moving forward? It is really partnership, partnership, partnership. We hired a new head of business development, Rahil Nasati, who have been very active and already now have some, some good leads and also been part of the program that we have in our semaglutide and get this industry partner to expand the collaboration. But we are looking now to basically expand based on the knowledge we have for the GLP-1 Agonist or semaglutide to get this partnership to expand and deepen We are looking in vaccines to test new vaccines with new, new vaccines with partners where we basically collaborate with them supplying some of it, Orexo with some of it, and we're seeking non-dilutive funding opportunities together with research institutions. And we have applications processes that have started in the US. On the development program, it's again, that's where we have Izipry, we have OX640. We are looking for a partner. We do need to take those programs to the next critical value inflection point. That means for Izipry and approval for OX640, our next pivotal trial. But we have started the partnering programs for both of them. And then we are looking basically for companies who would like to work with our platform for whatever project they have. It's again an area that we need to build and to be stronger, but where we are getting decent amount of interest. But before it's worth anything, we need to get a signed contract and get a signed partnership. Izipry, we resubmitted as we guided in the end of Q3. That means we have an approval expected in the end of Q1 next year. We are still waiting to get the PDUFA date confirmed by FDA. That should happen relatively shortly. We will continue to test reliability and stability, but that will be a significantly reduced expense than where we are right now. One thing that is interesting in the market for Izipry is that more and more data shows that patients who are overdosing with opioids in the US are administered more than one dose per— immediately after they are found by rescue workers, first responders, and bystanders. And that's basically because you're seeing that the current low-dose liquid products that we have on the market are not enough to, to basically rescue a person who are overdosing on a synthetic opioid. This is helping us because the market is now recognizing that these low-dose would need to go up in dose to basically be able to rescue the people. And that's where a high-dose product like Izipry comes in well with all of the other advantages we have with Izipry, including temperature-stable performance, for example. Moving to OX640. We are now on track to start our pivotal trial. It's the plan we had, and we've communicated for the last year. We are following that right now. We have met a lot of milestones for the program in the quarter, both the IND acceptance, our first commercial batch. We are now doing the testing to confirm it meets the quality requirements. Before we can release it. And that will then take us into— we can start the clinical trial. We are— and the clinical trial we're planning is the first pivotal trial, and that's basically testing— it's a nasal allergy challenge study where we're testing the products on allergic rhinitis conditions, meaning that we're exposing people who are allergic to pollen for pollen to get a reaction in the nose and see that the product has a good uptake. We've done that before, but not with the final dose and not with the final product. So this will be an important milestone for the company also. And that's coming into these value inflection points. And the next thing that will happen is that when our quality department have gone through all of the documentations from the commercial batch, we can then release it. That means that we have met the high standards that the FDA has set for the kind of rescue medications in the commercial manufacturing. This will enable us to start the pivotal trial. So we're expecting to announce that also in this quarter. And then with the results, we're saying now first half of next year, and we are expecting this to come early. But as it is with clinical trials, sometimes you need to do additional analysis, and that could push us into the beginning of Q2. But the expectations is it should be early next year, all depending on the quality of the data we get and if there's something surprising coming out. Of this study. Looking at the market for epinephrine products, we had some good Q2 numbers from, from the incumbent in the nasal market in the US. We are seeing good development in reimbursement with a decent price premium to some of the generic injectables in many markets. So this is promising for the market, which is still in its infancy. It will be interesting to follow how this market is evolving, which is an important impact parameter for potential partners who wants to work with, with Orexo on this. The market is competitive, but looking at the competitors in development and on the market, we see that there are unique profile and advantages with our AmorphOX technology that OX640 can take. For example, the rapid onset, it's very stable, extensive absorption, and we believe we can have a long shelf life on the product also. And then of course a value in the market is that we have a patent protection both for OX640 but also many of our other projects which are our technology on— projects on the AmorphOX technology which is reaching into the forties. The partnering process is ongoing and we're seeking a global partner. Could be different regions, but we are in a global process and we are expecting that the proceeds from that will take this product all the way to the end and be the financing of the final pivotal trials. So in the forecast that we have and the expectations that we have for the company moving forward, we have not included the next round of clinical trials needed to take OX640 all the way through the end. We're expecting that is coming out of this partnering agreement. Semaglutide, and we went out with a press release saying encouraging clinical results. We had, as you know, in '25 we had our first study where we saw we had very much higher bioavailability of the AmorphOX-based product in the nasal delivery compared to the oral formulation. The study we did now was on a more advanced reference tablet. It was also an oral tablet. It's the first time we have made an oral tablet with the similar— with the AmorphOX technology. We only used 4 different formulations, and this is done in a relatively short time frame, and that we in this short time frame could come up with a product that actually mirrors the, or have comparable bioavailability as the reference tablet, was encouraging. But of course, to be excellent, we need to have better bioavailability than products that are in the market and products that are in development. So this is giving us a starting point for continued development, and we're quite pleased to see that the industry partner we have worked with in the oral Tapplet are interested in continuing the oral but also interested in expanding into other routes of administration that we're now exploring how that project could look like and what would be the work plan for that before we can start the project. But we have a good dialogue and a strong interest, and, and it's basically not if we should continue, it's more about how we should continue. So to sum up, so from an operations perspective What are we looking for in the near term? We are in a partnering focus across the company. OX640 and Izipry, of course, top of, top of the list because we think that's where we have most value. So we are working actively to find partners. OX640 on a global scale, Izipry on a US scale. We're also looking to expand our AmorphOX partnerships to both reduce our expenses but also to reduce risk, and of course, for some of them, contribute positively into our profits. But it's going to give a stake into new projects by having other companies working with our AmorphOX platform. And then we want to— we want to expand into new areas, basically seeing where do we think this can work. And we are still very interested in biomolecules and very encouraged, not only on the semaglutide, but how that can be applied on other peptides It's also in vaccines. The data we have generated with Aberra, but where we're now looking to expand with new partnerships to get more proof of concept and vaccines, is going to be incredibly important in our efforts to expand the use of AmorphOX. And with that, partnerships, cost coverage, and revenues for the company. With this, I will leave the word to Fredrik to take us through the first part of the financial presentation. Fredrik, please.
Fredrik Järrsten (CFO): Thank you, Nikolaj. So starting with the P&L for continued operations, which we, as you know, after the divestment of Zubsolv US, will no longer follow that on a segment basis. The divested Zubsolv US business is presented in discontinued operations in Note 10 in the Report, and that will be the way for the remaining part of 2026. So on net revenues of 0.8 million SEK for the quarter, Upstart royalties were low, reflecting the continued trend of individual country royalty agreements expiring. Edlore royalties were also lower following launch of generic products in Canada. For Zubsolv X US royalties, we haven't received the royalty report for Q3 yet, and we haven't accrued for any growth in revenue but we hope to start seeing the effect of Accor's increased market efforts going forward, having finalized their Zubsolv manufacturing setup in Europe this past summer. OpEx amounted to €99 million for the quarter, or €92 million excluding depreciation, which is up from Q3 last year, but that includes a significant non-recurring provision of €35 million for the non-binding DOJ settlement accounted for in other operating income and expenses. We had also a positive effect from lower costs related to long-term incentive programs as a consequence of the decline in share price in the quarter. Otherwise, OPEX are lower in all functions. Selling expenses were lower than last year, mainly due to lower product strategy related costs and from staff reductions. Lower admin explained by generally lower spending and staff reductions, although still affected by high legal costs seeking a settlement in the DOJ investigation. R&D costs were also lower due to lower internal costs, partly offset by higher external costs for the continued development of OX640 and OX390. On the other hand, that also meant higher BARDA reimbursement of OX390-related costs of in total 7 million. Net financial items nowadays after the redemption of the bond give a positive contribution, 2.7 million this quarter, mainly explained by positive unrealized FX impact and higher interest income on our bank accounts. So net profit then for continued operations minus 118 million SEK also affected by a €22 million non-cash reduction of tax assets in Orexo US. And then net earnings for discontinued operations, plus €22 million, mainly explained by this positive revaluation of the expected earnouts from the divestment of Zubsolv that amounted to €21 million. On the next page, a further look at normalized OpEx in Q3, which I just said totaled €99 million, depreciation, €92 million, and then normalized for the non-recurring provision for the DOJ settlement and associated DOJ legal fees. Also normalized for negative FX effect and the positive effects from the lower Social Security costs for the long-term incentive programs. Then we arrive at the normalized OpEx of €55 million, or €18 million per month. Now, this is then the current situation on OpEx when normalized, but we have taken several initiatives to further reduce expenses from this level. So we have staff reductions with expected full effect in 2027. We have decreased facility costs. We have finalized the Izipry development, and we increasingly conduct new projects with partner contribution and risk sharing. And then we also have larger share of variable external R&D expenses indicating flexibility. Cost efficiency efforts will also continue going forward to further reduce OPEX. On the next page, we talk about cash flow. We reported a negative cash flow in Q3 for continued operations of minus €125 million, where we had a negative contribution from operating activities of €118 million, primarily impacted by negative operating earnings and and also negative changes in working capital. Working capital was mainly affected by payment of the Gaia settlement, 28 million SEK, which was accounted for in Q2 in relation to the termination of digital mental health products. Cash flow from discontinued operation was a negative 1.7 million. This is mainly post-transaction related restructuring costs and reimbursement for those costs following the transition agreement with Dexel. After adjusting for positive FX effect of 2.3 million, the total cash decreased from end of Q2 by 124 million to 153 million SEK. Now, under the transition agreement following the divestment to Dexel, Orexo also continues on behalf of Dexel to collect Zubsolv revenue from certain partners and make rebate payments to third parties. And this will continue until end of 2026. This also had an effect on working capital through account payables and other liabilities. And now this setup with Dexel is, is basically just a pass-through exercise with a net zero effect on cash flow over time. But out of the total cash and cash equivalents end of Q3 of $153 million, funds payable to Dexel was $65 million, and rebates in account payables related to Zubsolv amounted to €26 million. And that meant that Orexo's own cash end of Q3 amounted to €62 million. With that, further details on the spend of cash, Nikolaj.
Nikolaj Sørensen (CEO): Thank you, Fredrik. So I'm receiving a lot of questions about the cash flow and where are we spending the money. So we have decided to break that down a little further from our normal cash flow presentation. And also to show why we believe it's, it's the current run rate and cash burn is, is not a predictor of the future. If you look at the Q3, just as Fredrik said, we have about 70% of the relatively large amount of cash outflows are non-recurring, and it's related to the digital mental health business closed down and also the DUJ continued negotiation of the settlement. That's really the majority of the administrative cost We're also looking at some Zubsolv rebates. As you can see, we still have to pay that. And these are rebates that relate back to sale of Zubsolv in 2025. So we continue to get some invoices, but most of these €10.5 million, if not nearly everything, was in July. So that was early in the quarter. And we're expecting this to more or less disappear from now on. We also have some discontinued business, as Fredrik mentioned, that has a negative. And this is basically— we've had some employees working in the quarter Q3, and that also comes with a cost of running that discontinued business. And again, that now we're down to zero employees that are dedicated to the discontinued business, so that will diminish also. When we look at our continued business, which is basically R&D and focused around the AmorphOX, a lot of the expenses in this quarter was around Izipry, that we're preparing that for filing. That cost will drop quite significant next year. The OX390, we have done a lot of activities, but we have, due to some administrative processes, not received the payment from BARDA yet. And we're picking that up now as we're moving into Q4. So that will have a positive effect. But right now, all of the expenses for OX390 has been affecting our cash flow in this quarter. And then we have, of course, OX640, but where we are continuing, but where it is quite costly to produce 12,000 units of OX640 for the first time, which is also again that we're expecting to see after we've finished this pivotal trial that we're starting. We're expecting to see a drop in the cost of OX640 once we'll have a partner in place who will help financing the final steps before filing. So we are certain, and the aim for the company is to reduce OPEX significantly for next year. To increase the run rate. So we have the money that we get in now with the flexibility we have in our OpEx and in our cash burn, that, that will increase the runway beyond 2027. When we come to the full year cash flow, where of course everyone remember the sale of Zubsolv in the beginning of the year, and if we look at where we started the year and where we are today, it's of course a significant drop. And, but looking at where, where does this money go? So just taking some of the major items, most of them are non-recurring. So we have administrative costs that are coming in where about half of those administrative costs are directed to DUJ and the digital mental health business. But also in that number, we have other restructuring costs of the company that is included in terms of different advisors, uh, we have used during the year and also retained resources in the company during the first part of the year and even into where we are right now. We have more admin people than we will have from the start of next year. We have our discontinued business, and when you look at all of these pools, we have Zubsolv rebates, we do have Zubsolv account receivables, where those two are basically related both of them to sale of SubSol tablets last year. Then we have a larger bucket which is current liabilities, but even the current liabilities is also to a large degree related to directly to SubSol sales. Actually, just about $80 million of that are directed to our accounts payable in the US, and a large share of that is also related to rebates. So all of these 3 items that you have there in the middle Subsol rebates, Subsol account receivables, and current liabilities are going to diminish as we are ending— as we are finishing paying rebates for the market, and we are finishing collecting— we did that in the beginning of the year— collecting sales of Subsol that we sold in Q4 of last year. But the biggest item, of course, that we have is the bond repayment, and that was not something we had a lot of choice with. Our Bond repayment is basically— our bond had a security in the Zubsolv business in the US. And when we sold Zubsolv, we had to repay the bond. And with that came the repayment, which is $490 million. But also we had to pay for accrued interest rates, which is another $26.6 million. So just looking at where we are, a lot of these significant costs that we've seen during the year has been related to Zubsolv. But also a decent investment into our pipeline in the R&D program. When you're getting into the final stages of development, as we are with OX640 and Izipry, that is a significant expense. And then when it comes to OX390, Orexo have covered the expense so far for this year, but we're expecting to catch up with the BARDA payment during the fourth quarter. So significant cash outflow, but I think there's a good explanation to to these numbers that where the money have gone. Looking at forward, so, so where will we get our cash from? As Fredrik just said, we have our earnout in the— in from Zubsolv in the US, where we're just based on the trajectory we have seen until the Q3 of sales of Zubsolv, the development is looking good. We're pleased to see also that Dexel have invested into a larger field force than what they got from Orexo, so they're investing more into the commercialization than than what Orexo could do. So we are seeing that is helping our earnout, and we decided to increase the provision with $21 million, which is to the majority based on the trajectory, and some of it because this dollar has strengthened during the year. We also get the resource contribution from BARDA, which is up to $54 million. It is something that is supporting also our internal staff, so that's important part of financing our facilities and people. We continue to get royalty from our commercial products, and even though Abstral and ETLOR are in the late autumn of their lifetime. Then Zubsolv Europe, we are seeing now that our partner is gearing up their commercial activities as they during the summer could start selling their own material after having invested in building up European manufacturing capacity. Partnership by Izipry and OX640 will of course be important contributor also to support the company moving forward, so we're working intensively with that. But our strategy for the development is increasingly to work with partner-funded R&D of— for AmorphOX-enabled projects. And that means that Orexo can continue to take some of the expense, but we are reducing both risk and cost by having the partner to take the majority, with the aim of these programs turning into real partnerships where we actually get paid for the development, get milestones and royalties when the project— programs get to the market. It's also important for me to build in a lot of flexibility in our cost base, and as Fredrik mentioned, we have increased our amount of external expenses in R&D. The positive part of that is that they are all activity-based. That means that we can stop or delay an activity to control our cash burn and makes it easier to prioritize. So we are working to streamline our fixed cost base to have more flexibility, and we are on a good plan and have a good trajectory for that. And finally, we have our rights issue, as you're aware, that we expect to close later in this quarter. Moving into a short legal update, we did mention the Department of Justice. We are right now in basically discussing administrative items that needs to be in place. I would say this process has not been the highest priority of the Department of Justice. We also have a complexity that we have two individuals who worked for Orexo who have stopped working with us, but they also need to have their deal in place together with Department of Justice and some of these administrative processes. But there's no discussion at all about the head of terms, and we just need to finalize the process as it is right now. I would say Orexo right now is, is not in a super hurry because we have an agreement in place. It's not just to, to get this over the finish line. Of course, any delay right now also delays when we have to pay our first installment. And as Fredrik presented Based on that agreement, we have the first drafts received from the Department of Justice. In consultation with our auditors, we decided to make a provision for the payment of the up to $4 million over several years. So as you can see here, the number is a little less than that, and that's reflecting that some of the payment is late, in effect, all the way back in 2029, as it looks like right now. So summarizing a little and where we are, this is a slide that we've carried with us throughout the year to say what are we aiming for this year. Zubsolv Europe, we did get a release of the product from Europe, meaning that our quality department and Accord's quality departments have released the product for sale during the summer, and they are now expanding their commercialization into new markets in Europe. We did have Izipry file in the Q3, September 29th. We are planning to start the pivotal trial for OX640, but we're not there yet. But we are planning to start it on plan, on schedule here in Q4. OX390, we presented our in vivo study in Q2. And then finally, on GLP-1 Semaglutide, we have an additional in vivo study where we presented results now in Q4. From a partnering perspective, one of the most important now is that in semaglutide, the partner that we work with for the oral semaglutide are now together with Orexo looking at how we can expand this partnership into new delivery pathways, which we think is very interesting from a company perspective. And with that, We will open up for questions and answers, and we'll see if we have received the first questions. So I need to open that. Here we are.
InvestorCaller Host: 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 Samir Devani from RX Securities. Please go ahead.
Samir Devani (Rx Securities): Hi, guys. Thanks for taking my questions. I guess I've got a I've got quite a few. Where should I start? I'm going to just start actually on what you just commented about the partner on semaglutide, looking at other delivery options. Obviously Orexo is known for its oral and nasal delivery formulation technologies. What other delivery options are there?
Nikolaj Sørensen (CEO): So we haven't specified because we are working with the partner to see which one. But of course, it's quite clear close by to look at some of those we have worked with. But there are other ways you can work with a powder technology. You can work it for reconstitution, so basically use it as a way to extend shelf life and avoid cold chains. You can also work with inhalable products, for example, could be another alternative. And this is where we are both seeing some project opportunities where it could be led by Orexo, but also where the AmorphOX technology could tie into other technologies that the industry partner has. But, but we, we can't specify that right now because right now we are basically looking at which pathway should we work for, where do we see the biggest opportunity, and, and what is the work plan moving forward. So before we have agreed on that, I won't narrow it down to where we are. But of course, it's the ones that we have worked with are, are part of that list.
Samir Devani (Rx Securities): Okay, that's fair enough. Then on Izipry, you're expecting a 6-month review time, and I think you indicated that you're still suggesting that you have to wait for approval before you sign a partner. Is that correct?
Nikolaj Sørensen (CEO): The partnering process is ongoing right now, and we are reaching out to potential partners for Izipry. I just think some of the experience from the US market and even from Europe is that there are different set of companies who would look to a product that has been approved and one that has not been approved. And I think very simple argument for that is when it's approved, you don't need to do the due diligence of all of the documents that you have to in the file. So the expenses for you as a company to look into that product is much much lower when you have an approved product compared to looking at one where you have to weigh in whether you think there's a risk in the process. But of course, the dialogue with the companies is something that we are aiming to, to start and are starting before we are getting to the approval time. But I think that there are definitely a different set of companies who would be interested in products that are approved than even if The perception is that the risk for approval is relatively low, or that the approval will not be approved— that it will not be approved is relatively, relatively low.
Samir Devani (Rx Securities): Okay, and then on OX640, I just want to get a sense from you as to what— I think the study that you're doing is essentially a replication of one that was done with non-commercial products. So correct me if I'm wrong on that, but if that's That's correct. What's the remaining clinical trial program after that data that the partner is going to be required to do?
Nikolaj Sørensen (CEO): It is correct. It's, so we did do a similar study, although it was a different, the actual product was in a different dose. So we are using a higher dose in the final product more to be in this range of the competitors. And so we have done it before, and we think in that, based on the data, we think the risk in the study is relatively limited, even though there are always risks in clinical trials. When it comes to the, to the other studies that we have, so one study is that we need to have a self-administration study. So you need to basically test that patients are using this in the correct, correct way. We need to do a, a test in healthy volunteers which is not under nasal allergy challenge, and then depending on the results of this nasal allergy challenge study, there could be a need for a repeat dosing schedule. It depends on, on how, what data we come up with. So these are the studies that, that are remaining. I will say the critical timeline for OX640 is more in the manufacturing process than it is in the clinical trials because these Trials are all done, it's a bioavailability studies, most of it in healthy volunteers. And they can be done relatively shortly. The actual time to do them is not that long. But what we need to collect now, and that's of course an experience we carry with us for Izipry, is that on the commercial manufactured product, we need to start doing stability and reliability studies. And that's really at the moment the time-deciding factor in this process.
Samir Devani (Rx Securities): Okay, that's great. And then maybe just a few for Fredrik, just on— in terms of the numbers, um, I guess you gave us some indication of the underlying, uh, I think you mentioned 18 million SEK per month as a normalized sort of run rate. Um, but I think maybe it would be slightly easier if you could help us understand what do you expect in terms of a cash burn next year, excluding any form of licensing income?
Fredrik Järrsten (CFO): I think what we tried to explain the history, obviously, and the normalized number on OpEx that I mentioned is basically taking the Q3 numbers and adjusting that for the non-recurring items, basically. But, and then as you heard Nikolaj was explaining how we have used the cash historically. Now going forward, it was also mentioned that we are continuing the cost efficiency efforts. So we expect the OpEx to decline and further decline in 2027. And we also expressed that the cash flow will get closer to the EBITDA margin. And that is basically the guidance we have given in the presentation as well. I don't know if Nikolaj have an additional comment.
Nikolaj Sørensen (CEO): No, I can say the '18 is— that's higher than where we're aiming at. We are now looking— we are right now in parallel working with the budget for next year. And then our ambition is to have a runway which is taking us past 2027. So without having the income from partnering. So I think that's one part of guidelines. And to get to that number, of course, we need to reduce the cost from what was just mentioned just during basic math. Then, of course, it helps us that we get the earnout, which we're also taking into our overall cash amount. So the earnout is expected in Q1 of next year. So that's the guidance we have provided so far.
Samir Devani (Rx Securities): Okay. And then just 2 more questions for me. Just on the Zubsolv rebates, obviously, I was a bit surprised to see, again, quite a significant number in this quarter. You've mentioned that you expect them to sort of be gone by the end of '27. So I just want to confirm, there's no— when we're thinking about Q4 and beyond, there shouldn't be anything significant in terms of Zubsolv rebates? And then the second one is just what's the current employee count?
Nikolaj Sørensen (CEO): So on the Zubsolv payments, so this number was very early in July. So it was something that Basically, you have, for a lot of these insurance companies, you still have up to 6 months payment. That can still, and we've seen that before, that some invoices have come much later when also when some of, in particular, the Medicaid and Medicare in the US do audits, and then there can be adjustments in the rebates. But we don't foresee any significant numbers coming out from the rebate perspective moving from now on. It would also surprise me if that should happen. But the one we had now was something that was paid very early, I think July 2nd, 1st or 2nd in the month. When it comes to the current employee numbers, we are in total just about 50 people. And for that, we have 5 permanent employees in the US. We have one who's working part-time in the US. And then we have about 45 in Sweden. Then we are using some consulting resources in Sweden also that I'm not including in this number. And then we, we have a few people like Fredrik, who's sitting next to me. This will be his last Q3 quarterly presentation for Orexo. Fredrik is leaving the company in Q4 or end of this quarter.
Samir Devani (Rx Securities): Great, thanks very much.
Nikolaj Sørensen (CEO): Okay, with the— can see we have not received any additional questions, so with that I would like to finish this quarterly update and close.
InvestorCaller Host: There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.
Nikolaj Sørensen (CEO): We had a little technical hookup, so thank you a lot.
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