Orexo AB (publ) (STO:ORX)
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May 6, 2026, 5:29 PM CET
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Investing in Life Science 2025

Sep 25, 2025

Nikolaj Sørensen
President and CEO, Orexo AB

It's a pleasure to be here, so I'm going to present Orexo. We're at a quite interesting time right now when we're moving outside our usual focus area, opioid use disorder, and I will come back to that shortly. Just a short introduction to Orexo. We're a little unique Swedish company in the sense that we're one of the few that actually have ongoing sales. We have sales of close to SEK 600 million. We had positive EBITDA last year. We're projecting that this year also. We're a drug formulation company, and in that, we have brought four products to the market. We have a quite exciting platform that we're working on right now, which would be the next generation driving more products to the market, and I will spend most of the time today on this AmorphOX platform and a little less on our commercial performance.

For those of you who are interested in that, we have plenty of presentations on our homepage where you can look at that. Our suggestion today is we have a product on the market in the U.S., Zubsolv, that we're selling directly and with our own field force. Zubsolv is in a quite steady pace. It's a quite stable sales that we have, which is a little north of $50 million. In Europe, we are collaborating with Accord, the same company as Xbrane. They have launched and are doing quite well in a few markets in Europe, but they have invested a lot in a new manufacturing process for Europe internally, which will bring down the cost of goods and enable them to compete more in more countries in Europe. We have Abstral and Edluar, two older products where we're still generating some revenues through royalties.

The more exciting part of the company is really in our pipeline. The first product we have is Izipry. Izipry was before known as OX124. Izipry is a naloxone overdose rescue medication, high-dose naloxone overdose rescue medication. It has been a few years on the way. We've had some issues with the FDA. It's a quite hard sector to go into. These rescue medications need to have what you call a reliability of 99.999%. That means one out of 100,000 are allowed to malfunction. That put a lot of requirements on the manufacturing process. I'd say all of the issues that have been highlighted by FDA have now been solved, but what they are asking for is more what they call stability data, and we're generating that right now with an expected filing next year. The market for OX124 is becoming increasingly competitive.

We have in the market in the U.S. become OTC for the lower-dose naloxone products, and that also means that we need to look at how we're going to take this product to the market, and we will come back to that a little later. OX125 is also one we're taking into humans. It's a nalmefene product. We put that a little on ice because we want to see where the market is moving, and it's still on ice, I would say. More exciting are the two next products. OX390 is a project we haven't talked that much about, but when you look at the pattern of addiction in the U.S., overdoses are increasingly a combination of different substances, so it's quite rare today that you see someone overdose of pure heroin or fentanyl. They're mixing it with all kinds of other substances.

And there's one that is really on the rise right now, which is called xylazine. And xylazine is a veterinary sedation product, basically. You're using that when you're for horses, cows, and others. And now someone got the brilliant idea of mixing it up with fentanyl. The two in combination is increasing the risk of overdose quite dramatically. And this is an area we're looking at and where we're actually collaborating with U.S. authorities to see if there's a way where we can co-finance the next development of this project. So an exciting new opportunity. OX640 is an epinephrine product. So epinephrine is used for anaphylaxis, so when you have an allergic shock. We have done the first human studies, several of them. We have seen that we have a much faster uptake for patients who are under nasal challenge than even the injectables.

We have seen a more sustained effect than the nasal product that's in the market called neffy. But maybe most remarkable compared to the epinephrine products today is that we have a product that's completely stable even in 40 degrees heat. So it won't freeze, it won't degrade. And those of you, and statistically, there will be at least a handful of you here who are allergic and would carry around an EpiPen. And you would know that EpiPen needs to be stored in room temperature and has a quite short shelf life. We can do one that you can bring on your skiing trip, you can bring it to the beach, and it will come in the shape of a powder. Here we are in discussions with partners both on a regional and global basis and hope to close that relatively soon.

Then we have the other AmorphOX. Those of you who have been following Orexo the last few weeks have learned that if you just put GLP-1 into your title, then things will start happening. See if I can put it. Here we are. AmorphOX is the technology platform that we are so proud about. AmorphOX is a way where we can take basically we've shown any molecule in both, not any, but most molecules, both small and large molecules. Small being the typical chemical entities like naloxone. Larger molecules is all the way up to vaccines and proteins. Most vaccines are proteins. What we're basically doing is we're encapsulating the active substance within this small, you can say, carrier material. It sits in there and that protects it.

We've shown that products like mRNA products, we can keep them in high temperature and they don't degrade. We've seen that with vaccines. We keep those who should be frozen at 80 degrees, minus 80 degrees. When we put it into our AmorphOX platform, we can keep it in a powder and it stays stable. So we have a very stable product and we've shown that in both small and large molecules. We've also seen in multiple clinical trials that we have a very, very fast uptake. So when you push this into the nose, by being a powder, it will stick to the mucosa and then it will basically, because of the structure of the particle, it will break down immediately from the fluid that will be generated automatically out of your mucosa when it gets exposed to powder. That will break down and release the API.

We've seen multiple studies that we have a much higher bioavailability than any other nasal delivery form. As I said before, we've shown in both small and large molecules. Here's just a small example of what we're doing. Those small molecules, here we have the peptides, for example, semaglutide, which has a 0.1% degradation and 40 degrees temperature after six months. Biologics, we have done that in multiple different types of biologics and see it over and over again that in the powder it stays stable and the vaccines, for example, continue to be active. When you then look at where are we, so here are two examples. We work with a small Swedish vaccine company, Abera Bioscience, and we tested our powder compared to their liquid. As you can see here, the antibody response in both of them is quite similar.

That basically means that the powder is as good a delivery format as the liquid. What was more recent is that we also, a little under the, we haven't talked about that, but we have been developing this for the last year, is on semaglutide at GLP-1. And there you can see the curves to the left. So what we've seen is that in the powder, when we compare to Rybelsus, which is Novo Nordisk's oral tablet with semaglutide, we've seen that we have a seven times higher uptake through the nose than what they have through the tablet. But we also know one of the issues with Rybelsus is that it's not that conformed. So the dose conformity between patients is relatively heterogeneous, you can say. You are not allowed to eat for four hours, so there's a lot of issues using the tablet.

When we look at the data we have, we have much more homogeneous bioavailability among the subjects that we have here. And that's an in vivo study in animals. So it's a little early, but the indications are quite promising. And combining that with not needing a cold chain, which is needed today for semaglutide injectables, we think that this could be a quite interesting project. And just looking at the attention we have received both in Sweden and internationally, this is something that has actually opened up some eyes. So very interesting next project. Looking at our financial situation, as I said, we have a revenue coming in. It was close to SEK 600 million last year. One thing I will say is that nearly all of our sales, more than 90%, is dollar denominated. And we do not hedge our dollars.

Just looking at what the dollar has moving, this has an impact on the top line. Fortunately, most of our expenses are also dollar denominated, so the actual impact on profitability is lower. It has more impact. If you look at our P&L the last few quarters, it has quite a lot of impact because we also have most of our money in dollars. And that, of course, hits the P&L. But we still expect that this year we will have a positive EBITDA. It's been a little wobbly over the quarters, partly due to some one-time events, but from a full year perspective, we still believe we will be in a good position. Finally, where are we right now? The focus for us is, of course, to create a stable financial business. Zubsolv is important because it's generating steady revenues.

But I have said before, and this is, we are kind of open to see the Zubsolv asset, to see how does it generate most value for the shareholders. And that continues both through looking at partnership, looking at, for example, looking at keeping the product stable on the market right now. We know that the U.S. market access is incredibly important, and this is something that we're working with both the Zubsolv to expand and maintain our market access, but also for future products. This is something that we're really working on much earlier than we were done previously. How can you secure market access and reimbursement? And then finally, the AmorphOX technology, OX640, find a partner, find new larger molecules where we just, like Martin said before, we also see that the biologics and large molecules is the growing part of life science.

And this is where we think we have a unique delivery method through nasal administration. And with that, my time is out. Thank you so much. I know you said that if people wanted to know about the small molecules, they could look on the website, but of course, someone's asked here about what the commercial plan is for the small molecules, if you could just briefly. So the one that is closest is OX124. And there we have seen the market is moving more and more OTC. And that means that our products are prescription products. This market has become a, we have a high dose, the lower dose, which is the common prescribed, or not was commonly prescribed, became OTC. And there we've seen a price pressure, and we have to see what is the effective way to get to the market.

Because to go out in OTC, you would normally have to establish a brand name. So here we need to look at more institutional sales, finding other niche access rather than going broad because it will cost much more than what we can get in return. But we're overlooking this entire platform in light of how the U.S. market is developing. And it has become more competitive. That's just a fact.

Someone here has asked if you've ever considered going private or if you're happy to remain on the stock market.

It's not really my decision to go private. If someone comes and makes an offer for us to go private, then we have to consider that like any other offer.

I think we have a pragmatic shareholder base and owner, but right now, so if one of you wants to buy the companies, just come forward with a very good offer. Then we are open for discussion.

Come talk to Nikolaj at lunch.

Yeah.

Got another question here about your platform, saying that you earlier mentioned platform partnerships for this fall. Are you still confident to present such deals on time?

I think that's a good chance. But one thing I have learned, and I've said that multiple times, is that you don't have a deal before you have a signed deal. So we can work, and we have done that throughout the summer, but we won't have a deal before it's signed.

One thing that is with life science right now, and I have seen that, and that's not for these partnering projects, but we were working on an R&D partnership. Large molecule, we had two workshops. Second workshop, the day after it was announced that the company was bought by another company. That's kind of what happens when you have exciting opportunities. They get bought, and then they come back and say, "Okay, we think this is really interesting, but right now we don't know who will stay here." Another example is actually mRNA. We work with mRNA companies and were quite close to moving. Suddenly the U.S. administration pulled all financing of mRNA studies overnight, which basically made all of their projects in jeopardy because they were relying on financing from the U.S. government. That's something that we can't really control.

I think just we need to say when we have a signed deal. I'm sure my excellent head of communication, Lena, will come out with a press release immediately, and then you will know about it.

Another question about talks with Sobi and how they are progressing. Apparently last fall, you said that their tests exceeded expectations, but then it's been quiet.

Yeah, and that's another good example. So when you work with R&D, we get tasks that this is what they want to see, and we deliver the task, and then it goes in and becomes a part of the prioritization in the company. This is really, and we said that all the time. It's up to Sobi to decide when or if they want to proceed. We have delivered what they were asking for.

Our project has basically met all of the endpoints that they were setting up. But I think that we do the same at Orexo. Our R&D department is free to go out and partner and find other innovative technologies. If it turns out positive, it goes up to management and even to the board to decide, are we going to finance this project? And that's a longer and more difficult decision process than for an R&D department to use a few millions to test a new molecule.

So for now, the ball is in their court.

It's in their court. We still talk with Sobi, but I think right now they've decided, at least for this year, they're prioritizing other projects.

Other projects. I think that it's just about everything we have.

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