Orexo AB (publ) (ORX) Earnings Call Transcript & Summary

Welcome to the conference call. [Operator Instructions] Now I will hand the conference over to the speakers. Please go ahead.

Good afternoon, everyone, and welcome to this second quarter interim report presentation from me, Nicolas Hanson, the CEO of Orexo; and Fredrik Jastin, who is the CFO of the company. For those of you who have been following the day, you understand that this quarter -- the second quarter of this year, we have continued to clean up the company and going through the transformation after the sale of ZUBSOv in the end of last year. This has had some impact both in terms of operational expenses where we have resolved disputes and discussions with suppliers, which have -- so we've taken a onetime cost on some of these contracts to exit some of those contracts. We have also continued to phase out employees from the U.S. and also reduced the staff in Sweden during the quarter. So all in all, we have -- in this quarter, we have an inflated both cash flow position and OpEx position, which is driven by this transformation that we are going through, but we feel it's important right now for the company to come through with a clean slate and be as transparent as possible of where we stand at the moment. So where are we right now? I think in parallel with working through all of these different operational items to prepare the company for the new future, we, of course, continue to work in our R&D programs, which is really where we're building value long term. And if we look at what we accomplished during the quarter, our 390 project, we have gone through an in-vivo study, which has positive results. IZIPRY, we are well on track to file in Q3 in September. OX640, we're on track to start the clinical trial that we are scheduled in for Q4 this year. We are also, during the quarter, we started where -- we can call them early stage scientific collaboration with an external pharmaceutical company to basically work out with the AmorphOX application to GLP-1 harness. That is an early stage, but it's good access for the company to really understand how we can optimize this program to create interest from pharmaceutical companies. I'll come back to that a little later. We have also strengthen our business development. We have recruited a new head of business development here. So there's really to leverage the interest that we have seen, growing interest in our AmorphOX platform from different companies. We have intensified our discussions with the Department of Justice. This has been something that has been following us more or less to the date, I think it was the 14th of July that we started and 6 years ago. So it's a little more than 6 years now, and we really would like to put this behind us. It's a difficult process. It evolves more than Orexo. It's also some of the employees in the U.S. So this is a complex process to coordinate, but we are making progress. we look to be transparent from where we are right now. We have opened the process to look at what are the financing opportunities looking forward. And this is in terms of our strengthening our position in our business development discussions long term to show that we have alternatives and we are well-financed to complete the programs, together with the partner, but also, of course, to ensure that we can continue with high pace even if we should reach a settlement with the Department of Justice. I'll come back to some of the details around that a little later. As you saw in the report, we have a cash position of SEK 233 million. It was a relatively significant cash going out this quarter. A lot of that is associated to rebate payments and others from [indiscernible], that was before we added [indiscernible] business in the U.S., and Fredrik will comment on that a little later. So a little more into the details. So where are we? As you know, we are working with, say, 3 segments: of explore, development and partnering. And if we look at the programs that we're running right now is all of them are built on the AmorphOX platform. So why? It should look like we are quite differentiated and work with a lot of different programs. Actually, what we do as a company is very focused around the AmorphOX technology. And our involvement in the explore space in GLP-1 in infectious disease is limited for us to do the AmorphOX powder. If it's a naval delivery, we can also support next steps, but we really look at partners who should take the heavy lifting of driving the program forward rather than Orexo, for example, becoming a vaccine company. But we do see that the technology is very valuable or could be very valuable for vaccine companies. Where we do have more efforts is in our developed segment, where we're working with anaphylaxis of the 2 agonist intoxication and opioid overdose. These programs are those who have been running for a while. And as you know, a couple of them are now approaching their final stages, so it's kind of a legacy for working with this. I don't see that Orexo should become vaccine moving forward. But there, we will rather work with companies who are active in that space. So in a little more detail. GLP-1 agonist, we are working towards an in-vivo study this quarter to start that in oral formulation for GLP-1. We're [ not ] pleased to have what I would call a scientific collaboration. So don't confuse this with a partnership, but it gives access to quite high quality input in terms of methods for study design. It's about how to do the analyst analytical methods in the -- or it's about access to some excipients that we're working with. So this is an important for Orexo as we have not worked with GLP-1 before to have access to that kind of competence. And of course, it gives us a foot -- if the results are good because the partner was doing this with an expectation to look at those scientific results and see if this is applicable to that portfolio. So we are, as I said, ready to start an in-vivo study with an oral formulation in Q3, but we also continue to work with the nasal formulation and also there, we would be looking for partners to support the company moving forward in nasal formulations. Infectious diseases or vaccines. It's quite interesting to see what's happening in the vaccine world. I see more and more recognition of the value of a nasal formulation, and this is exactly the sweet spot for AmorphOX. And here, I'm quite pleased with my experience of going to U.S. buyer in San Diego a few weeks back, where we met several vaccine companies and actually gained some good traction and interest of testing our technology to vaccines that could be taken later or even for some companies, existing vaccines that could eliminate the need for [indiscernible]. So this is something that we really see there's a big opportunity for AmorphOX. But again, we don't do this with anticipation that Orexo should suddenly become a vaccine company. It is basically to allow the technology to florists with other companies and enable their vaccines to be delivered nasally and/or bring a [indiscernible] and thereby having much longer stability and much easier distribution to the end user. For our anaphylaxis study, OX640, we are well on track to start our nasal allergy channel starting Q4. What's needed for that is to upscale the manufacturing to what we call commercial scale. That means the testing needs to be done on the final commercial product. Here, we are fortunate that we have the entire manufacturing change setup for IZIPRY, so we can basically use the setup with the reliability data, with the FDA inspected process for IZIPRY, we can use on OX640 taking away an immense amount of work and risk from the OX640 project. It's a very large market, and I see more and more recognition even scientifically for the need for a more convenient formulation like a nation [indiscernible] formulation. There are some momentum building in the market in the U.S.. Even though it's still small, it's interesting to see that they have -- after 1 year, they have surpassed the size in sales than what we have with [indiscernible] when we were at the peak level and continue to show quite good year-over-year growth. Through agonist intoxication, that's our OX390 project, I would say, a real -- the active substance that we're working with atipamezole is used daily by veterinary clinic all over the world onto the brand name [indiscernible]. And the big test here isn't nasally absorbed in a way that is meeting the need for bioavailability to have a nasal formulation because this is really what we see as the opportunity here is not to develop a new injectable but to have a nasal formulation that can be widely distributed to first responders and community workers and maybe even patients. And here you see that we have successfully gone through this in-vivo study. And with all of our experience of running in-vivo studies and other formulations, we are quite certain that the data we see in the in-vivo studies in animals is applicable to humans as we come further along. Although at atipamezole is available for animals, it is in the eyes of the regulatory [indiscernible]. It is an NCE project. That means that we actually have to do a lot of toxicology testing and what we call preclinical testing before we're ready to go into the clinic. As you know, this project is to the vast majority financed by the American authority data. Opioid overdose, our IZIPRY or [indiscernible], we are well on track to file the product in September. So we expect to have the filing in September, and that would mean the expected review time from FDA is 6 months. That takes us into the end of Q1 when we should have approval in the U.S. For both the 640 and the opioid overdose programs, we are starting -- or we're intensifying the partnering process where we are looking to -- for OX640 to have a partner who can take the commercialization or partners because it very well be different partners for different regions in the world. This is clearly a global product, but we will have partners who can support both the finance development and also the commercialization. We expect from Orexo, we have the funds and are expecting to drive the study to the national allergy channel study, but would then look for a partner to take the program over the last regulatory studies and also stop the commercial manufacturing. In opioid overdose, we also see a major milestone is the submission to FDA. So when we reach that, it's also a very good trigger of really intensifying the partnering efforts for the U.S. market. So where -- and just to give an overview of our future, where we are putting most of our money right now and are expecting to have most of the investments moving forward is the 640 program. And this is a program where you -- we're addressing anaphylaxis. So for those of you who are new to the company, anaphylaxis is when you get an allergic shock and you need epinephrine to basically reverse the allergic shock. Today, this market is to 99% dominated by auto-injectors on a global scale. There is a nasal formulation that's coming into the U.S. and have been started to launch in some markets in Europe also. And it is interesting real-life data that comes out of those, both from Europe and also from the U.S., where we start to see scientific evidence and value of having a more convenient administration than the auto-injectors. And there was a recent study sponsored by the Danish company, [Indiscernible], who is launching a nasal spray in Europe, where nearly 40% said they didn't carry their anaphylaxis products regularly, which is a big risk because you -- rarely you get the anaphylaxis shock when you're at home, you often get it in a place where you can't control how the food has been treated or what is happening around you. So we see here that having smaller and more convenient, more stable formulations would have a major meaning for patients, and we believe this is going to drive continuous growth in this segment. One of the hurdles, we saw that with naloxone when that was launched back in 2015 in the U.S. nasal naloxone products. It took some time before people got convinced that a nasal formulation has the same effect as an injectable. And it took basically, I think, 2 years before we really saw the market starting to pick up in the U.S. with nasal naloxone. And today, that is completely dominating the market. Should that happen in the epinephrine market, we are looking at a market that is worth more than $3 billion on a global scale today. For Orexo, we have somewhat around SEK 200 million left in external expenses. Then we also have an internal team working with this, of course, and the majority of this is expected from the second half and into the first half of 2028, where we then expect during the summer to have the filing ready if everything goes according to plan. And we will seek a partner to run this -- and why do we think this is an important project? It's basically because we're just looking at the product profile of OX640 compared to the competitors, we see a product that is more stable. We see rapid onset. We see that we have an extensive absorption of the product and even after an extended period. So we don't see a drop in the amount of epinephrine. We basically see that we continue to have an extended absorption even on the nasal allergy challenge in the first study that we have. And that is something that is differentiating us from the competitor in the market today. We see an opportunity to have a long shelf life. We have an incredibly stable product. We don't see any degradation, which you actually see on both the nasal liquid in the market today and also in the auto-injectors. And then on top of that, we have IP exclusivity to at least 2044. So it's a long runway from where we are today with OX640. So even smaller part of $1 billion market is highly valuable for Orexo and of course, for partners who are willing to pick up the product. So what are we trying to do in part from our projects? And I'll just say with AmorphOX, this is really part of what we're trying to build on right now is when we look at the global market for pharmaceuticals, we see some growing issues where we believe AmorphOX can be a solution. It's around stability of biomolecules. We see a lot of the vaccines and biologics require cold chains to remain stable. And even under cold chain, they have short shelf lives. Cold chain is a bottleneck and a growing bottleneck in both in the pharmaceutical manufacturing, but also when you come out in the distribution of the product to the end user. This is something that we can address. There are limited biomolecules. They are, by far, the majority are delivered through injection. We think that there could be opportunities for more to be delivered through nasal. And we have seen, as you saw our first nasal study on the GLP-1 agonist semaglutide through the nose show a much higher bioavailability compared to the reference product. We see an increasing patient interaction model that is changing, in particular in the U.S., where patients are more and more relying on virtual interactions or vitro interactions with their physician and then home delivery of their product. So you basically instead of going to the pharmacy, and this has caused an immense amount of closure of pharmacies in the U.S. the last years, we see that patients are expecting to get the product sent home. Of course, that is an obstacle if you have an injectable and also something that requires a coal chain. Finally, well, if you're just doing a normal injectable, you will have little IP associated with the formulation. And we have today a long IP and the more APIs we're putting into a more for the longer IP we expect to have. We even have for GLP-1 agonist, our IP is expected to go into 2047. So that's actually 21 years from where we are right now. So we can with AmorphOX offer a significant extension of IP for many products and development. And if you look at vaccines, and this is where we really see a big value, because we see that most of the vaccines are very, very sensitive, and we can provide something, more stability. And one thing I would highlight here just a very recent Swedish study that was talking about how you need [indiscernible] or to avoid the effect of influenza and others. You can maybe be injected and have a systemic immunity, but if you don't have the local immune, you will still get sick, maybe not as serious but being sick also mean that you can spread the virus. And by having something that we create a local immunity, we'd like to have a much bigger opportunity to stop the virus from spreading and avoid disease at all. So this is an area, and it was interesting to see that Swedish studied at the Swedish Hospital -- Dental Hospital, to see how they came to the conclusion that we need to deliver flu vaccines through the nose to ensure full immunity in the vaccination. So I think we are quite spot on to one of the real hot topics in the vaccine space at the moment. And then our model. So again, the risk, of course, by working with so many different molecules is that you are getting too fragmented and spread your resources across many different areas, what we are basically doing is that we are offering companies with. [Technical Difficulty] Sorry, I believe I got disconnected here. So I hope that it [indiscernible] too much. And the sound quality is still good. So what we're trying to do is basically with the AmorphOX platform is offering a way to create -- we do the powder, and then our partners will basically have to lead the clinical development and the development and supportive data for the API. We can then, of course, based on all of our experience from having -- taken products to market offer support throughout the entire development process, all the way up to manufacturing and to do some of the clinical testing. But of course, broad clinical trials, we will need to rely on the partner to do this. So really, the work that we are offering is focused around creating a powder where we encapsulate the API and make it bioavailable either through the nose or to reconstitution where you can avoid cold chain and also increased the stability in shelf life of the product. And we're taking this to customers, to our business development group where we just recruited [indiscernible], who is a long experience from business development to work with both large and small pharma companies, most recently as CEO of a small vaccine company. And with [indiscernible], we are basically working to leverage the increasing [indiscernible] we've seen in AmorphOX and to create new collaborations. So building on the early-stage scientific collaboration, looking for other partners in the GLP-1 space. We see high interest from the U.S. authorities and thermostability in vaccines. So again, going with other companies and maybe build on our experience with BARDA to seek financing together with other companies to test these nasal formulations should be feasible. And we have right now several ongoing discussions with Swedish and international vaccine companies where they -- we're discussing how can we best assess the value we can bring to their vaccines. So the focus areas in business development right now is in the AmorphOX platform. It is finding a commercial partner for IZIPRY ahead of approval in Q1 next year and also to work to find one or more partners for the ORX-640 project where we see this project could be purely a global -- have global opportunities where IZIPRY is more U.S., and we think OX640 is something that deserves to have a global market. So to round off, why do we think that we are at an interesting time right now. I think Orexo, we have several products that are right now approaching approval or very close in the final stages. We have IZIPRY that we are expecting to file just within a few months. We have 640, which we could file also in 2028 with approval either late that year or first approved late that year or early the year after. We have an OC-390 project, which is maybe a little longer ahead, but the risk in the project, both from a development perspective, but in particular, also from a finance perspective is relatively low because Orexo is only covering a fraction of the expenses. So we are doing this based on our differentiated AmorphOX platform. I think we -- again and again, we see that we can do stuff with APIs that no other company can do. We have our high-value late-stage pipeline. We have experience. We have taken 4 products to the market. So we know what it takes to get a product approved. And we see that we have multiple quite interesting inflection points coming up relatively soon in the company, such as the [Indiscernible] exported commercial scale manufacturing, NACT study results, new partnerships and collaborations around the AmorphOX platform. And with that, I will open up for Fredrik to take us through some of the financial numbers. Fredrik, please.

Thank you, Nikolaj. So starting with the P&L for continued operations, which we, as you know, after the divestment of ZUBSOLV U.S., no longer follow up on a segment basis. Now divested ZUBSOLV U.S. business is presented as discontinued operations in Note 10 in the report and will be presented that way for the remaining part of 2026. So on net revenues of $3.5 million for the quarter, Abstral royalties were low, reflecting ongoing trend of individual country royalty agreements expiring. In addition, royalties were also negatively affected by the turmoil in the Middle East. Edluar royalties were also lower following launch of generic products in Canada. ZUBSOLV ex U.S. royalties, on the other hand, were higher, explained by positive true-up of Q1 royalties, where we hope to start seeing the effect, of course, increased market efforts when finalizing their ZUBSOLV manufacturing setup in Europe. OpEx. So that amounted to SEK 107 million for the quarter, which is up from Q1 last year, but the absolute majority of that difference comes from a settlement with GAIA, as Nikolaj talked about, terminating the collaboration in relation to digital mental health products. That increased admin expenses by approximately 20 million. Selling expenses were lower than last year, mainly due to lower marketing-related costs for ri and lower digital mental health product activities. Admin were higher mainly, as I mentioned, from the settlement with GAIA, but also from increased legal fees seeking a settlement in the DOJ investigation. R&D costs were also higher following higher costs for the development of OX640 and OX390, which, on the other hand, also meant higher BARDA reimbursement of OX390 related costs of in total SEK 4.5 million. That being the main reason for a total positive contribution from other operating income and expenses of SEK 5 million. Another comment on OpEx and the total this quarter of SEK 107 million, and we look at what that would be without nonrecurring items such as the settlement with GAIA and normalized with no transition-related expenses or legal costs in relation to the DOJ investigation. -- we would for the quarter instead look at OpEx of some approximately SEK 60 million, excluding depreciation or annualized about SEK 240 million. We are also continuously looking at how to become more and more cost efficient going forward. We have, for instance, reduced the Swedish workforce with approximately 10% after this transaction. Net financial items nowadays after the redemption of the bond give a positive contribution. It was SEK 1 million for this quarter, mainly explained by higher interest income from bank accounts. Net profit is then for continued operations, minus SEK 102.5 million and for discontinued operations, plus SEK 2.1 million. And there, the restructuring costs post transaction are starting to phase out, although will remain in some degree until the transition period has ended, likely in September. And next page, cash flow. We reported total negative cash flow in Q2 for continued operations of minus SEK 98 million, where we had a negative contribution from operating activities of SEK 93 million, primarily impacted by negative operating earnings, a negative adjustment for noncash items, where the major part was payment of provisions for outstanding rebates related to ZUBSOLV sales in 2024 -- sorry, that is before the transaction with Dexcel. These rebates will decrease significantly going forward are expecting to be fully phased out by year-end. We have like SEK 3 million left to be paid of our provisions for rebates in the last 2 quarters this year. Furthermore, we had positive changes in working capital, mostly related to an increase in accounts payable from our own operations. And then under the transition services agreement following the divestment to Dexcel, Orexa also continues to collect ZUBSOLV revenues on behalf of Dexcel during the first 9 months of the year, which also had an effect on working capital through both accounts receivables and accounts payables. Now the setup with Dexcel, though, is just a pass-through exercise with a net 0 effect on cash flow over time, but SEK 44 million of our cash in the balance sheet end of this quarter is payable to Dex. So cash flow from continued operations was a negative SEK 98 million, as I said, cash flow from discontinued operation was a negative SEK 14 million. And this is mainly from payment of severance and other post transaction-related restructuring costs. So the total negative cash flow for the quarter is then SEK 112 million. After adjusting for a positive FX effect of SEK 2.6 million, that meant a decrease of our cash from end of Q1 of SEK 109 million to SEK 277 million, out of which then SEK 44 million belongs to Dexcel. So our own cash is SEK 233 million end of Q2. And with that, back to you, Nikolaj.

Thank you, Fredrik. And as you can understand, this is a relatively complex exercise, particularly given the U.S. setup where you have returns, you have rebate payments and some of those returns on rebate payments are coming in quite late and can be associated with the Orexo sale of ZUBSOLV prior to the transition to Dexcel. So this has been a period of transformation and also to -- where we have to work with parallel both continued and discontinued operations, which, of course, is clouding the picture a little about the financial performance. But I can promise you, we are working intensively to bring down our spend and to really focus our resources where we see most value and to avoid future expenses associated with the U.S. legacy operations, that means the commercial operation. So to the legal update, and we did mention that, but we have intensified the discussions with the DOJ. We have when we look at the structure that we expect, it would be a settlement where the payment will be over several years. So there will not be one big payment coming when you have reached the settlement. It's something where I think there's a very constructive dialogue with the DOJ for what is feasible for Orexo to ensure that we can continue our operations looking into the financial situation of Orexo, which is some of the stuff we have done during the spring is basically to show forecast and also give the DOJ a full insight into our ability to pay in such a settlement, which, of course, is relatively limited given where we are at the moment. We also expect that parts of this will be covered by insurance. And as I said before, the settlement will cover not only Orexo, but also some individuals who have been working in leading positions in the U.S. And for those individuals, we have a D&O insurance, which should cover their exposure, which should take a decent amount of the total settlement and the amount should be covered then by insurance. However, the discussions are ongoing. It's not been closed. It's a slow-moving process. So it's something that we have been spending, as Fredrik said before, a decent amount of legal fees during the quarter and historically quite a lot of legal fees. But I do see that we have made some progress during the quarter, which give us some confidence that we can approach a final resolution, even though I'm also fully aware that the details in the settlement agreement is still to be worked out. Our position remains that we have been compliant. We have used external legal advisers, regulatory advisers to review our commercial material and training material and others, and we get the work from our lawyers that we have been compliant. However, given where we are, this has been going on for 6 years, we would really like to put this behind us and also to avoid the cost of a potential legal proceeding in court in the U.S. and also the continuous expenses that we have right now to manage this process. So final slide. We have shown this before. EU, we haven't seen an effect of the EU sales yet. I will say right now, we -- what we have in our account is actually based on projections, not the final sales report. But we do know that the EU material was released in the end of the quarter. So we expect relatively soon that the material from Act will reach the market and be the basis for the future commercialization in Europe, which should give them a much more competitive cost of goods in the European market, which in its turn should also have a positive impact on the Orexo royalties. 390 in-vivo study, as you understand, is important, and we will relatively soon, next -- in just a few months, we will hopefully put another buck next to the Q3 filing of IZIPRY. And then a trial start of OX640 will come shortly thereafter, plus the in-vivo study in GLP-1 agonist which is scheduled for this quarter also. So we are looking quite well to basically put a tick in the box between each of these milestones in the short term. And we are working now with a much stronger business development setup after BARDA have joined us to increase the number of partnerships and get more companies to test and work with our AmorphOX platform. With that, I just remind you about our financial calendar. Next report is coming October 22. And we are participating in the numerous, and this is just a small section of some of the activities where we are with business development. And again, with Ah joining, this is an area where we expect to increase activity levels quite substantially during the next half year. So with that, I will open up for Q&A.

[Operator Instructions] The next question comes from Klas Palin from DNB Carnegie.

And my first question is about this DOJ process that you're sounding a little bit more optimistic that you are making progress. Is it possible to share any further details what has happened in this process during the past month?

Thank you, Klas. So the DOJ, what we are working with is a slightly moving target because there have been some reorganizations at the DOJ. We're working on several different legs to try to resolve this, talking to different people within the Department of Justice, but the main constituents are, of course, is the Western District of Virginia. It's one prosecutor office who initiated this investigation. What I can say because we haven't -- we can't disclose any details, but I will repeat what I've said previously is the -- if you look at the size of the case, the claims and also the number of involved parties, meaning both Orexo and some individuals, the total expense to run such a process is likely to be north of $10 million. So the logic -- the rationale decision if you see that threat is to look for a settlement when you're in that neighborhood if you can get to a reasonable financial terms. And that goes not only for Orexo, but it also goes for our insurance companies. And we are here in the discussions, we are expecting to see insurance coverage for a decent amount of this -- so I can't disclose any more details as we are in negotiations at the moment. But this is some of the logic that we are looking at is we really would like to close this. And of course, what we would like to avoid, even though we believe we have a strong case is to enter into a court process where it would be very difficult to get back some of the legal fees. And of course, there's always a risk when you go to court that there will be part of the decision, which is not positive for the companies or the individuals involved in the process.

But you have a clear counterpart at the authority to discuss these issues with today?

Yes. We have -- there's no permanent prosecutor assigned to the Western District of Virginia. As you know, the T blanch, I believe, was confirmed yesterday as a new Attorney General for the U.S. And I think that's been a little of a delay in that process. But there is an interim head of the district, and that's the person that our legal team is speaking to.

Okay. And then another question then. You have done a lot of cleaning of your business this year. And if we exclude the DOJ process, are you done now? Or is there any more cleaning to do?

So I would say we -- right now, we are at a position where we have one person who still works on a temporary contract in the U.S. In Sweden, we have also one person who is also working with a final end date in the quarter. And I don't see any other supplier contracts that we would need to review as it looks like right now. So yes, we are done in that line. What I will also remind is we -- in Sweden, we're actually moving out of our existing offices, and we're moving to a smaller and more space-efficient office closer to Uppsala University. And in the new office, we expect to see nearly half of the expenses for our office. That, of course, is not directly associated with the U.S. transaction, but it's something that will have full effect from next year.

Great. And just my last question then is related to OX390. I guess you have had a meeting with the FDA now. Were you satisfied what came out with this meeting?

This was about our preclinical work, and we got full support from FDA on the plan. There was -- as always, there are some suggestions for things that we could add on further details, and we are working together with BARDA to discuss those activities and of course, expecting to continue with the same setup with BARDA, where the majority of those expenses will be covered by BARDA. So that was good. FDA also basically wanted to start a process discussing the clinical program. So they're accelerating that process ahead of the IND. I think that is quite positive also because the clinical program is is a little more complex setup because you can't go out and test the product on the end users because they are basically people who are suffering from an overdose with different kind of adulterated opioids on the street. So to have that dialogue early with FDA, I think, is quite beneficial for the company. And I will say 390 is creating a lot of interest not only from BARDA, but also from other authorities and all the way up to the White House in the U.S. They are desperately looking for solutions to this drug that's called T or overdose combined with fentanyl. So this is something that is creating -- gaining a lot of traction on a political level on both sides of the eyes in the U.S. I think this is an interesting project because we're really in the center of U.S. politics with this project. And we are the only one working with an overdose treatment that we are aware of for a trunk.

The next question comes from Samir Devani from Rx Securities.

Let me kick off with the DOJ, just a further clarification on the DOJ because there's clearly been some movement this quarter. I just wanted to check, has the DOJ sent you a settlement term sheet?