Orexo AB

Orexo AB

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Feb 04Next Earn

Q1 FY2026 · Earnings Call TranscriptApril 28, 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 answers 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 on the call. I'm pleased here to report our first quarter of 2026.

Together with me today, I have Fredrik Järrsten, who will go through the financial results of the report. As this is the first report that we have without Zubsolv, and that of course has a significant impact on the way that we're presenting the data and also the length of the presentation, as we don't have the commercial asset with us anymore.

A short summary of where we are right now: and this has been a quarter which has been one of the most intensive from a work perspective for most of us, together with the end of last quarter due to the transition of Zubsolv. As we sold that on the last day of 2025.

Of course most of the transition activities [unclear]... During the quarter, of course a lot of these activities have led to a reduction of cash position because we're paying a lot of these for Zubsolv, and we redeemed our corporate bond.

In the end, we have cash and cash equivalents [unclear], excluding the 52 million SEK on the balance sheet right now, which actually should attribute to Dexel because we're running their accounts receivable. All in all, I think the transition with Zubsolv has been very successful.

It has been very smooth. There has been no interruptions in the sale of Zubsolv in the market in the US.

The collaboration with Dexel have been running smoothly, and we're quite pleased to see how the sales of Zubsolv has continued after Dexel took over, which is good for Orexo and the earnout that we're anticipating next year and the year after. When we look at our development programs, we have seen a steady progress according to the plans.

Both OX124 is on track for filing later this year. OX640 is on track for initiating clinical trial, nasal allergy challenge study, in the end of the year.

Also, OX-390 is making good progress, and we have an ongoing in vivo data study where we would expect the results to come here in the second quarter. In addition, we've been working on expanding the use of amorphOX, in particular into the GLP-1 space, where we have one nasal program ongoing, but, based on some feedback and interest, we're also testing whether this could support an oral formulation.

We'll come back to that in more details. Just to remind those of you who have been following Orexo, the way that we're looking at the business right now is basically in three arms.

One is that we're working in what we call exploratory, that's early-stage programs where we haven't set a full development program and timeline, where we're using the amorphOX technology into new areas such as peptides, GLP-1 agonists, or vaccines. We have the other leg is our development program.

That's when we have a set timeline, we're planning for clinical trials, and all the way up to submission to the regulatory authorities across the world. Here we have three programs today.

Then we have our last leg, and that is when we're partnering our technology and basically making the amorphOX technology available for other companies' programs and where they can use that to accelerate or to improve the properties of their programs. On the first area, the explore, the big focus during the quarter has been on the GLP-1s and in particular in semaglutide.

We have expanded now into an oral formulation where we're looking to see if we, by using the unique properties of the amorphOX particle, we can basically combine the peptide, semaglutide peptide or other peptides, together with excipients that can improve the bioavailability of the peptide when it comes into humans. We are planning for the first in vivo studies on this during the summer.

On vaccines, we have been looking a lot to start up collaborations, in particular with other parties than just Abera, and we are in good progress to expand into new key opinion leaders and in particular within academia to see where we can basically test a broader span of vaccines together with our technology. Then we have our proprietary development programs.

As said before, OX124, everything is on track for the submission that we're planning for in Q3. As we have to redo some of the stability studies in the final manufactured process, you can say.

Right now everything looks like we can submit according to plan. For OX640, a lot of the focus during the quarter has been on setting up manufacturing processes in Canada together with our contract manufacturer.

That is required to have this final commercial product is to be used in the pivotal trial that we're planning to initiate in the fourth quarter or end of this year. We've also been working on human factor studies, and when you are working with human factors, that's how humans are going to use the actual device.

The way to do that is first what you call formative humans factor studies that is tests and the instructions for use, and we've been doing that during the quarter with good success. That means that we are then ready to start the real human factor studies that are going to be used for the regulatory submission when we want to.

Then finally, on 390, we are now working with our first in vivo study, waiting the results in this quarter. We're also planning for a Type C meeting with FDA that we've been planning together with BARDA, and that is with a big focus on our non-clinical plans.

That Type C meeting is with the FDA. All in all, all of these programs are doing steady progress, and have basically followed the plan for this quarter.

When it comes to the partnering, that's when our technology is to be used by other partners. As we've talked about that several times, we have been working with quite a few, both smaller and larger companies, to test the feasibility of amorphOX.

We now need to move some of these programs into more concrete partnerships, and we are in dialogue with some companies about programs in different phases where we will get coverage of our expenses and also programs that are intended to lead into a longer-term partnership of program development. As we said multiple times, it's very hard to forecast when these agreements will be in place.

It takes two companies to get to a conclusion, but we are working hard to expand this pipeline of programs. Then Fredrik will lead us into the financials.

Fredrik Järrsten

Yes, thank you, Nikolaj. Starting with the P&L for continued operations, which following the divestment of Zubsolv US, as of this quarter, we do not longer follow up on a segment basis.

The divested Zubsolv US business is presented in the report as discontinued operations in Note 10. On net revenues, 5 million SEK for the quarter, we have lower Abstral royalties, following the trend we've seen for a while now as individual countries' royalty agreements expire.

We had higher Edluar royalties, though, from higher partner sales in Canada. We had lower Zubsolv ex-US revenues, explained by [unclear]...

were minimal this quarter and lower than last year, and that's mainly due to lower marketing-related costs for OX124 and lower DMHP activities. Admin higher legal fees seeking a settlement in the DOJ investigation.

R&D costs also higher following higher costs for development of OX640 and OX-390, which [unclear]... of OX-390 to 7 million SEK.

That's the main reason for [unclear]... higher bond loan costs, and that's following the early redemption of the corporate bond that we completed as of March, partly offset, though, by higher interest income.

Net profit for continued operations was -105 million, and for discontinued operations, -20 million. That's mainly explained by the restructuring costs post transaction, including severance [unclear]...

will remain so that's that page. On cash flow for continued operations of -528 million SEK.

Of that, the absolute majority is a consequence of the early redemption of the bond. During the quarter, we exercise our right to carry out the redemption of outstanding 500 million SEK...

[unclear]... negative impact 19 million SEK.

[unclear]... part was payment of provisions for outstanding rebates related to Zubsolv sales in 2025 and also following 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 revenue on behalf

Operator

of Dexel during the first part of the year. That had a positive effect of 52 million SEK on working capital in Q1.

That is however to be paid back to Dexel. Cash flow from continued -528, cash flow from discontinued operations in -7.5 million, mainly from payment of severance and other post-transaction-related reduction costs.

After adjusting for positive FX effect of 9 million SEK, that meant a decrease in cash and cash equivalents of 526 million to 386 million, out of which 52 belongs to Dexel. With that, back to you, Nikolaj.

So... [unclear] Sorry for the delay.

This is the operator. We will continue soon, trying to fix the sound problem.

[unclear]...

Nikolaj Sørensen

We try again here. We were just disconnected.

Sorry again for that. Our expectations here is for OX640 that we'll have a clinical trial start or the pivotal trial starting in the end of this year with the result early next year, but also the manufacturing of the clinical trial material is incredibly important in pharma development, and that's something that we will do now during the second quarter.

OX-390, we are waiting for the in vivo study results, and that of course is a very important for us to get into the next stage together with BARDA. The collaboration with BARDA is going very well at the moment, and I think we have a very constructive discussion with BARDA about how to optimize the development and how to run the timelines moving forward.

We are, of course, also looking forward to the Type C meeting with the FDA. We think this project is incredibly important for the US government and for the strategy of combating opioid addiction and death in the US.

Finally, we have our GLP-1 agonist and our vaccines. We're expecting to have some additional in vivo studies in the oral formulation, and we also continue to work with the nasal formulation, which if positive could lead into the first human studies next year.

In parallel with all of this, we are working with all kind of partnerships, both on a technology basis, on a knowledge basis with academia, but of course also with pharma companies where we can have co-development programs in one shape or form, either them basically using our technology or getting access to our own programs. We are looking for a partner for OX124, and we think it's a good trigger to have the filing ready in the US, we are starting this process right now.

OX640, we will also be looking for a partner, and I think here the manufacturing and meeting the timeline of the clinical trial in the fourth quarter is an important milestones. With that, I will close the presentation and open up for Q&A.

I open for...

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 Klas Palin from DNB Carnegie. Please go ahead.

Klas Palin

Hello, and thank you for taking my questions, even though I want to mention that I didn't hear that much of the presentation. Excuse me if my questions has already been addressed.

I just wonder, Q1 2026, how typical quarter is this for the new Orexo, if we exclude what you're doing with DOJ for the moment?

Fredrik Järrsten

If we... [unclear]

Klas Palin

Sorry, I can't hear you.

Fredrik Järrsten

Nikolaj... So...

Nikolaj Sørensen

If you can hear us, we'll dial up using another number. So...

Klas Palin

Great. I can hear you.

Nikolaj Sørensen

Can you hear us now?

Klas Palin

Fredrik, if you... All right.

Fredrik Järrsten

Maybe different perspectives on that question, Klas. If I address it from a cost perspective, obviously, we're in the transition period, and costs within discontinued operations obviously related to transition.

Also in continued operations, we are affected by additional costs in relation to the transition. Now if we look at a sort of normalized OPEX annual and deducting those extra costs, to say, then we would estimate an annual OPEX, assuming also that the projects that we are running now, an annual OPEX excluding also depreciation of 250 million SEK.

It's an estimate, Klas.

Klas Palin

Sure. That's fine.

Fredrik Järrsten

That's the angle. You said also in relation to the DOJ investigation.

Klas Palin

If you could provide some granularity about that, would be great, of course. I don't know what you can say.

Nikolaj Sørensen

I would say we can't say that much more right now. It's a difficult process, not the least due to personnel change at the DOJ or 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.

Klas Palin

Okay. Perfect.

Just my last question then, just wonder if you could provide some timeline when you think that the phaseout will be completed of the divested business.

Fredrik Järrsten

We expect the transition period to last sometime after the first half of the year, I guess September, October would be a fair estimate. In that period, we will phase out in continued operations the people that are busy with the transition, but then no longer needed.

With that end of transition period, discontinued operations for this year, there will be no cost or income in that. That's a fair estimate, I would say.

Klas Palin

Okay. Great.

Thank you. Thank you for taking my questions.

Nikolaj Sørensen

Sorry about the quality of the line. It's unfortunate.

Operator

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

Samir Devani

Hi, guys. I guess I've got a couple of questions, really just again coming back to the transition and the 52 million SEK that's owed to Dexel.

I'm assuming that's for returns and rebates only. I just wanted a, I guess, a bit more granularity: how much were the returns and rebates, is that all for Q1, the 52 million, or should we be assuming that will be paid in Q2?

Is that correct?

Fredrik Järrsten

There's different aspects to that as well, Samir. The 52 million, that refers to Orexo collecting sales revenues from Zubsolv.

Obviously, that's just a pass-through. The 52 million is not belonging to us.

That's the easy part. Now in relation to rebates and returns, we started the quarter with 155 million in provisions for rebate.

Now a big part of that is following separating an asset, and we are to pay rebates for those assets that were there in 2025. We have paid also following the purchase agreement, where we had commitments and provisions in relation to the agreement.

That has been dealt with during Q1 to large extent. We paid, out of the 155 million, we paid 109 million in rebates.

That means that we have still left some 40 million in rebates to pay going forward.

Samir Devani

Okay. That's very helpful, Fredrik.

The 52 million, in Q2 will there still be pass-through payments coming, or will Dexel have taken it all over by then?

Fredrik Järrsten

No, that would be taken over as we speak, but there would be probably new, since this lasts for 9 months, there would be new pass-through money to clear to Dexel.

Samir Devani

Okay. That's fair enough.

Then I guess my only other question is just on the BARDA collaboration. You mentioned obviously we're going to see some in vivo data in Q2.

Is that a no-go/go point in the collaboration then? If so, what do you need to show for the collaboration to progress?

Nikolaj Sørensen

I think in all of the development there's a continuous go/no-go. If things are turning out in a very unfortunate way, then you have to consider, is this worth redoing?

Should we redo the formulations? We're testing several different formulations in the in vivo study, and should it of some reason all of them show no indication for 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're running other programs or have been running other programs in these early stages without sharing the information, but because we have an income, we're of course giving an update continuously on the BARDA partnership.

I will say what we're testing in the in vivo study is the nasal uptake, and there have been some evidence that the active ingredient is available and have uptake through the nose. We think that we have a good shot on goal here.

Of course should it turn out that there's no uptake, then it will need to be a new discussion with BARDA: is it worthwhile adjusting the formulation, is there other delivery methods that we should test, or should the program not continue? I think the [edetate disodium?]

as we went out at the R&D Day is well researched and have been tested and is used daily in veterinary use across the world, it's a well-documented API, but just not for humans.

Samir Devani

That's great. Thanks very much for your help.

Nikolaj Sørensen

Thank you. We have a problem here that I'm really sorry about the sound.

We recognized that when we got disconnected. We have a few comments about that, and it's my apologies.

We need to go back and look at what we can do to address that next time to avoid the same thing happening. Then we get a question about what are the value triggers in near time.

Delivering on our development program is of course what we have most control of and basically meeting the development milestones that we have outlined now with in vivo data from 390 that Samir was just asking about, our submission of OX124, the continued development towards starting the 640 program in the autumn. I think all important data points.

Also in vivo data on GLP-1s, should that turn out positive, that would be an important trigger. Then on top of that, we of course have partnering discussions.

From experience, I would say it's very hard to put a timeline on some of these processes, but it's not because they're not ongoing. There are partnering discussions ongoing on different types of development programs, and should they come in, I would expect that that has a positive impact.

As I said, we're running negotiations and discussions as we speak. We are of course optimistic that we will have some partnership that we can share.

Time will tell. There's no deal until we have a signed agreement.

I do think it's quite important if you look at the overall market, there's also external drivers that can have impact. Taking the OX640, I would look at the transition or transformation of an injectable epinephrine market and how it's moving to get into nasal.

As there are nasal alternatives available in Europe, some countries in Europe. In the US, just got approval just a few weeks ago in Canada.

This transformation going from injectable and auto-injectors into nasal I think is an important value trigger, since OX640 is relatively close by in development terms and is a late-stage, quite low-risk asset. I think that to recognize value in that will be an important value trigger.

With that, we have no further questions, and once again, my sincere apologies about the sound. Fredrik and I, we could hear each other quite loud and clear on our side, but unfortunately that sounds like it has not really gone through to all of you.

We did have a lot of sound checks before we went into the conference, something must have happened during the meeting. My apologies for that.

I will then invite you to listen into our future presentations and when they are, that's available on the homepage. Thanks a lot, and goodbye.