Orexo AB

Orexo AB

5.18
SEK
-0.17
(-3.18%)
843.05MMarket Cap
Oct 22Next Earn

Q3 FY2026 · Earnings Call TranscriptOctober 22, 2026

Operator

Welcome to the conference call. For the first part of the conference call, the participants will be in listen-only mode.

During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now I will hand the conference over to the speakers.

Please go ahead.

Nikolaj Sørensen

Good afternoon, everyone. I'm Nikolaj Sørensen, and I'm the CEO of Orexo.

Welcome to this third quarter 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.

We labeled this quarterly report Orexo in transformation, and it has indeed been an intensive year from 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. As 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.

To summarize 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 filed Izypre on the 29th of September. We resubmitted the file to FDA, and we expect a six months 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 can say is 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 640 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 OX-390, 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.

On each of these three 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 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-dilutive grant funding to basically test AmorphOX platform on different vaccine projects.

For Zubsolv in the US, we have in this quarter—it might passed some of you, but every quarter, we're reviewing our progress, and see where we believe we will be with the earnout. 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.

We are increasing the amount that we expect to get paid in the earnout in early next year. We also announced that 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 have been forced into in about six years.

It's taking a lot of effort, a lot of money also, to get to the point where I am right now. I'm quite pleased that we actual 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 are entering into as a company.

Then we have our rights issue that we announced recently and that we're now going to conclude during this quarter. The transformation that we are into, as 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 cost 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. 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.

We are making some decent progress in this space, which is basically the plan that we set up for the company when we took the decision to sell off the US business last year. When it comes to the rights issues, it is something that will give us the flexibility to continue the development through critical milestones.

We will come to the financials later, and I can say the financial results that you're 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.

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're allocating the funds, we're seeing that 640 remain one of the larger expenses.

It was that for this year and also in this quarter. Then we have our 390 development, where most of it was financed by BARDA, but Orexo still have to take some.

Our continued project with semaglutide and other GLP agonists, we have in there. Vaccines, we are looking for non-dilutive financing, but we will need to take some expenses for that.

Izypre, we set 10%. I think that's a high number because we are now basically done with the majority of the work, but with, as it is with any program, then we for Izypre, we will need to continue monitoring shelf life and also reliability data, but that's a significantly lower cost than we have right now.

Then we, of course, have the DOJ and general strengthening of our working capital. What is the focus for the company moving forward?

It is really partnership, partnership, partnership. We hired a new head of business development, Rahila Nasaji, who have been very active and already now have 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.

We are looking now to basically expand, based on the knowledge we have for the GLP agonist or semaglutide, to get this partnership to expand and deepen. We are looking in vaccines to test 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 Izypre, we have 640. We are looking for partner.

We do need to take those programs to the next critical value inflection point. That means for Izypre an approval, for 640, our next pivotal trial, but we have started the partnering programs for both of them.

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.

Izypre, we resubmitted as we guided in the end of Q3. That means that we have an approval expected in 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 Izypre is that more and more data shows that patients who are overdosing with opioids in the US are administered more than one dose immediately after they're found by rescue workers, first responders, and bystanders.

That's basically because you're seeing that the current low-dose liquid products that we have on the market are not enough 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 Izypre comes in well with all of the other advantages we have with Izypre, including temperature-stable performance, for example.

Moving to 640, we are now on track to start our pivotal trial. It's the plan we had and we communicate 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. The clinical trial we're planning is the first pivotal trial.

It's a nasal allergy challenge study, where we're testing the products under 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.

This will be an important milestone for the company also. That's coming into these value inflection points.

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 mean 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. We're expecting to announce that also in this quarter.

Then with the results, we're saying now first half of next year. 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 the incumbent in the nasal market in the US. We're seeing good development in reimbursement with a decent price premium to some of the generic injectables in many markets.

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 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.

Then, of course, a value in the market is that we have a patent protection both for 640, but also for many of our other projects, which are our technology on projects on the AmorphOX technology, which is reaching into the '40s. 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. In the forecast that we have and 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, we went out with a press release saying encouraging pre-clinical results.

We had, as 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 AmorphOX technology.

We only used four different formulations, and this is done in a relatively short timeframe, and that we in this short timeframe could come up with a product that actually have comparable bioavailability as the reference tablet was encouraging. Of course, to be excellent, we need to have better bioavailability than products that are on the market and products that are in development.

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 on the oral tablet 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.

We have an good dialogue and a strong interest, and it's basically not if we should continue, it's more about how we should continue. To sum up, from an operations perspective, what are we looking for in the near term?

We are in a partnering focus across the company. 640 and Izypre, of course, top of the list because we think that's where we have most value.

We are working actively to find partners, 640 on a global scale, Izypre 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.

It's going to give us stake into new projects by having other companies working with our AmorphOX platform. Then we want to expand into new areas, basically seeing where do we think this can work.

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 Abera, but where we are now looking to expand with new partnerships to get more proof of concept in 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

Thank you, Nikolaj. Starting with the P&L for continued operations, which we, as 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. That will be the way for the remaining part of 2026.

On net revenues of 0.8 million SEK for the quarter, Abstral royalties were low, reflecting the continued trend of individual country royalty agreements expiring. Edluar royalties were also lower following launch of generic products in Canada.

For Zubsolv ex-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 Accord'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 a lower cost 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 640 and OX-390. On the other hand, that also meant higher BARDA reimbursement of OX-390-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. Net profit then for continued operations, -118 million SEK, also affected by 22 million non-cash reduction of tax assets in Orexo US.

Then net earnings for discontinued operation, +22 million, mainly explained by this positive revaluation of the expected earnout 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 less 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 effect from the lower social security costs for the long-term incentive programs. Then we arrive at a 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. We have staff reductions, with expected full effect in 2027.

We have decreased facility costs. We have finalized the Izypre development.

We increasingly conduct new projects with partner contribution and risk sharing. 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 -125 million, where we had a negative contribution from operating activities of 118 million, primarily impacted by negative operating earnings 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 Dexcel.

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 agreements following the divestment to Dexcel, Orexo also continues on behalf of Dexcel to collect Zubsolv revenue from certain partners and make rebate payments to third parties.

This will continue until end of 2026. This also had an effect on working capital through accounts payables and other liabilities.

Now this setup with Dexcel is basically just a pass-through exercise with a net-zero effect on cash flow over time. Out of the total cash and cash equivalents end of Q3 of 153 million, funds payable to Dexcel was 65 million and rebates in account payables related to Zubsolv amounted to 26 million.

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

Thank you, Fredrik. I'm receiving a lot of questions about the cash flow and where are we spending the money.

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 the current run rate and cash burn 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 close-down and also the DOJ continued negotiation of the settlement.

That's really the majority of the administrative cost. We also looking at some Zubsolv rebates.

As you can see, we still have to pay that. These are rebates that relates back to sale of Zubsolv in 2025.

We continue to get some invoices, but most of these 10.5, 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 have had some employees working in the quarter, and that also come with a cost of running that discontinued business.

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 Izypre that we're preparing that for filing.

That cost will drop quite significant next year. The 390, 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.

Right now, all of the expenses for 390 has been effecting our cash flow in this quarter. Then we have, of course, 640, but where we are continuing, but where it is quite costly to produce 12,000 units of 640 for the first time, which is also again that we're expecting to see after we have finished this pivotal trial that we're starting, we're expecting to see a drop in the cost of 640 until we'll have a partner in place who will help financing the final steps before filing.

We are certain and the aim for the company is to reduce OPEX significantly for next year, to increase the run rate, we have the money that we get in now with the flexibility we have in our OPEX and in our cash burn that will increase the run rate 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.

Looking at where does these money go, just taking some of the major items, most of them are non-recurring. We had administrative costs that are coming in where about half of those administrative costs are directed to DOJ 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 we've 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 had 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 Zubsolv 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 directly to Zubsolv sales. Actually, just about 80 million of that are directed to our accounts payable in the US.

A large share of that is also related to rebates. All of these three items that you have there in the middle, Zubsolv rebates, Zubsolv account receivables, and current liabilities, are going to diminish as we're finishing paying rebates for the market and we're finishing collecting—we did that in the beginning of year—collecting sales of Zubsolv that was sold in Q4 of last year.

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.

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. 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 640 and Izypre, that is a significant expense. Then when it comes to 390, Orexo have covered the expense so far for this year, but we are expecting to catch up with the BARDA payment during the fourth quarter.

Significant cash outflow, but I think there's a good explanation to these numbers that where the money have gone. Looking at forward, where will we get our cash from?

As Fredrik just said, we have our earnout in from Zubsolv in the US, where we're just based on the trajectory we have seen until the third quarter of sales of Zubsolv. The development is looking good.

We're pleased to see also that Dexcel have invested into a larger field force than what they got from Orexo, they're investing more into the commercialization than what Orexo could do. 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, of course, the dollar has strengthened during the year.

We also get the research contribution from BARDA, which is up to $54 million. It is something that is supporting also our internal staff, so that's an important part of financing our facilities and people.

We continue to get royalty from our commercial products, and even though Abstral and Edluar 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 for Izypre and OX640 will, of course, be important contributor also to support the company moving forward, we're working intensively with that.

Our strategy for the development is increasingly to work with partner-funded R&D for AmorphOX-enabled projects. That mean 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 program gets 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 easy to prioritize. We are working to streamline our fixed cost base to have more flexibility, and we're on a good plan and have a good trajectory for that.

Finally, we have our rights issue, as you're aware, that we expect to close later in this quarter. Moving to 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 the Department of Justice and some of these administrative processes.

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 not in a super hurry because we have an agreement in place.

It's not just to get this over the finish line. Of course, any delay right now also delay when we have to pay our first installment.

As Fredrik presented, based on that agreement, we have the first drafts received from the Department of Justice. In consultation with our auditors, we decide to make a provision for the payment of the up to $4 million over several years.

As you can see here, the number is a little less than that, and that's reflecting that some of the payment is all the way back in 2029 as it looks like right now. 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 have Izypre filed in the Q3, September 29th. We are planning to start the pivotal trial for 640, but we're not there yet, but we are planning to start it on plan on schedule here in Q4.

390, we presented our in vivo study in Q2. 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 worked 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. With that, we will open up for question and answers, and we'll see if we have received the first questions.

I need to open that. Here we are.

Operator

If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad.

The next question comes from Samir Devani from RX Securities. Please go ahead.

Samir Devani

Hi, guys. Thanks for taking my questions.

Yes, 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

We haven't specified because we are working with the partner to see which one, but, of course, it's quite close by to look at some of those we have worked with. There are other ways.

You can work with a powder technology, you can work it for reconstitution, basically use it as a way to extend shelf life and avoid cold chains. You can also work with inhalable products, for example, is another alternative.

This is where we're 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 we can't specify that right now because right now we are basically looking at which pathways should we work for, where do we see the biggest opportunity, and what is the work plan moving forward. Before we have agreed on that, I won't narrow it down to where we are.

Of course, it's the ones that we have worked with are part of that list.

Samir Devani

Okay. That's fair enough.

Then on Izypre, you're expecting six-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

The partnering process is ongoing right now, and we are reaching out to potential partners for Izypre. 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.

I think a 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. 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.

Of course, the dialogue with the companies is something that we are aiming to start and are starting before we are getting to the approval time. I think that there are definitely a different set of companies who would be interested and come in products that are approved than even if the perception is that the risk for approval is relatively low, or that it will not be approved is relatively low.

Samir Devani

Okay. 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 the non-commercial product.

Correct me if I'm wrong on that. If 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

It is correct. We did do a similar study, although the actual product was in a different dose.

We are using a higher dose in the final product more to be in the range of the competitors. We have done it before, and based on the data, we think the risk in the study is relatively limited, even though there're always risk in clinical trials.

When it comes to the other studies that we have, one study is that we need to have a self-administration study. You need to basically test that patients are using this in the correct way.

We need to do a test in healthy volunteers, which is not under nasal allergy challenge. Then depending on the results of this nasal allergy challenge study, there could be a need for repeat dosing schedule.

It depends on what data we come up with. These are the studies that are remaining.

I will say the critical timeline for 640 is more in the manufacturing process than it is in the clinical trials, because these trials are all 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.

What we need to collect now, and that's, of course, an experience we carry with us for Izypre, is that on the commercial manufactured product, we need to start doing stability and reliability studies. That's really, at the moment, the time-deciding factor in this process.

Samir Devani

Okay. That's great.

Then maybe just a few for Fredrik just on in terms of the numbers. I guess you gave us some indication of the underlying I think you mentioned 18 million SEK per month as a normalized sort of run rate.

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

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. 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, we expect the OPEX to further decline in 2027. We also expressed that the cash flow will get closer to the EBITDA, and that is basically the guidance we have given in the presentation as well.

I don't know if Nikolaj, you have an additional comment?

Nikolaj Sørensen

No. I can say the 18 is higher than where we're aiming at.

We're 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. Without having the income from partnering, 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 also taking into our overall cash amount. The earnout is expected in Q1 of next year.

That's the guidance we have provided so far.

Samir Devani

Okay. Then just two 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.

I just want to confirm, when we thinking about Q4 and beyond, there shouldn't be anything significant in terms of Zubsolv rebates? Then the second one is just what's the current employee count?

Nikolaj Sørensen

On the Zubsolv in payments, this number was very early in July, for a lot of these insurance companies, you still have up to six months payment. There can still, and we've seen that before, that some invoices have come much later, also when some of, in particular, Medicaid and Medicare in the US do audits, and then that can be adjustments in the rebates.

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.

The one we had now was something that was paid very early, I think July 2nd, 1st to 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 five 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 are not included in this number.

Then 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

Great. Thanks very much.

Nikolaj Sørensen

Okay. Can see we have not received any additional questions.

With that, I would like to finish this quarterly update and close—

Operator

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

Now,

Nikolaj Sørensen

we had a little technical hookup. Thank you a lot for all of you who listened in to the conference call, and I wish you a continued good 22nd of October.

Thank you a lot.