Orexo AB

STO:ORX

Earnings Call Transcript 2021-Q2

[Operator]

Hello, and welcome to the Orexo AB Q2 report of 2021. [Operator Instructions] Today, I'm pleased to present Nikolaj Sørensen, Chief Executive Officer. Please begin your meeting.

[Nikolaj Sørensen, President & CEO]

Thank you very much, and again, welcome to the first half results for Orexo. It's no doubt today has been a sweaty day not only due to the heat wave in Sweden, but also with looking at our share price. However, when I'm looking into our [ Q ] report and looking at the progress we have made on both ZUBSOLV and also on our digital therapies, I think there are some quite strong reasons to be optimistic about the development moving forward. And with that, I will start the presentation, and I will go into Page #4. So Page 4. A short summary of the quarter here. So if we look at the U.S. Pharma business, we have seen a stable sales comparing to the last quarter. The positive part is that our core segment, the open market, in particular, the open commercial segment, that's a private health insurance market, we have actually seen a little growth in a market that has been more or less standing still. We also now into Q3, we have on the 1st of July, we got full market access to Medicaid in Kentucky, the fourth largest Medicaid state in the U.S., a state where we have literally not been active before. So this is basically new, we can say, a completely new market for us. So looking at this core market growing, looking at the opportunity in Kentucky, and then looking at where is it that we are losing a little in demand and that continues to be these exclusive contracts where the exclusivity was removed back in 2019. And those of you who have been with us for that time will probably recall, we had a market share of about 90%, 9-0% in these big health plans, UnitedHealth Group and Humana. That's very difficult to defend. And while we're still a big player, it is still a challenge to keep up with the previous market share in these 2 plans. But we have seen that the decline has been fading and is now on the lowest level since 2019 in terms of decline. On our digital therapy business, we have, and I talked about that in the last quarter, we are now focusing a lot on making contracts with partners, starting up pilot tests and bigger trials. And the first trial we started with last year was with Trinity Health in North Dakota. And that one has now finally turned into a commercial contract. Trinity Health, North Dakota will now offer vorvida and deprexis as part of a treatment plan for alcohol misuse for vorvida and depression for deprexis. We also have a couple of other contracts with a clinic in New York City and also a mental health hospital in St. Louis. However, these are just small beginnings. And what is interesting is to see that the pipeline of partnership discussions is expanding not only in numbers, but also in the size of these partnership discussions, and I will come back to that. With regards to our pipeline, the big focus right now is on OX124 and we are just literally days away from starting the pivotal trial for OX124. And in parallel, we are working on our ZUBSOLV case. As you know, we have our patent litigation case. And fortunately, we have just during the last little more than 6 months, we have 4 new patents issued and 2 of those patents were actually issued during this quarter. So when we started the year or the patent litigation with Sun, we had 5 patents listed in the Orange Book for ZUBSOLV, now we have 9 patents listed in the Orange Book for ZUBSOLV. Moving into OX124 and that is in -- start on Page #6. When I woke up this morning, I saw the news about the number of people dying from overdose in the U.S. We have known that it has grown, and we have reported about that for the last few months that during the COVID-19 crisis, the number of people dying from overdose in the U.S. has continued to increase. The numbers that I saw this morning, or actually late yesterday evening, was the number for 2020, it's 93,000 people dying from overdose. The vast majority of these overdoses are from patients who are using fentanyl that's a synthetic opioid. It's fentanyl that is produced by illegal laboratories, often in Mexico. And what we know with fentanyl is that it requires a more powerful rescue medication, and that's exactly what we are developing with OX124. So we are really looking forward to get the pivotal trial over and done, get our commercial stability data, which is right now the time-limiting factor to get that ready. That's a 12-month stability study that Orexo has started now in June and that would enable us to file with the FDA in the second half of next year. So looking at where we are, Page #7, we have a commercial supply chain established, and we have all preparations for the pivotal trial starting. And as I said, we're just days away from starting this study. We have initiated our 12-month stability study, which is required by the FDA. Just looking ahead what can we expect, we are now starting the pivotal trial and -- it's a relatively small trial, but you need to have a, what's called, a washout period between taking in different groups of patients. So we expect to have the results in early Q4, but that's really not the time limiting for this project. It is the stability study that is going to take time. With that, we will expect to file our product application in the second half of next year with a launch in 2023. One of the interesting part with OX124 is that when we started the project, we started on a venture to solve a specific problem. We needed to start the overdose with fentanyl. Doing that, we have invented a new technology, a new type of nasal sprays. And we're now taking that technology and applying it on other APIs. And we have 1 project, you're aware of, OX124 -- OX125. It's also an overdose rescue medication with nalmefene, but we actually see several other APIs where it could be interesting to apply our new technology. And we are right now doing, what we call, in vitro tests of these new APIs and hopefully, that will lead to a new project that we could start soon when we are done with the in-house development of OX124. Moving into our digital therapies. So I would jump into Page #9. If you look at the space of digital health, I have noted that during the quarter, for example, one of the companies who has been a first mover in the space and also one where we have some directly competing products, it's Pear Therapeutics were acquired or merged with SPAC, and so one of these new vehicles on the stock exchange. And with that, Pear Therapeutics were valued at $1.6 billion. I think that is quite interesting because if you look at the sales of Pear Therapeutics, in particular, that which is coming from their prescription digital therapies and not from license fees from larger pharma companies who have license in that technology, they are also in the infancy of the launch of their products reSET and reSET-O. And I think they have a third one also in the market. But the valuation they have is $1.6 billion. And that is interesting because it just shows that it's not only Orexo who has quite high expectations into digital health, it's also very much something we share with a lot of investors in the U.S. Looking at what we have accomplished during the quarter, as I talked about in the last quarterly call, a lot of our focus is to drive sales through partnerships. We have always thought that the direct sales to consumers through our web pages, us.vorvida.com and us.deprexis.com, is going to be a quite small fraction of the total sales that we would generate. So to get some of these concrete agreements in place with health care providers has been a core of the strategy when we started. And we're now happy to see that we have some first movers, in particular, Trinity Health, North Dakota, which is what's called, integrated health distribution networks. That means it's a network of health care providers that have several different units in contrast to the New York Clinic or the mental health hospital in St. Louis, which is 1 site. Trinity Health, North Dakota have several sites. And the Trinity Health North Dakota has been something that we have been able to use as a reference in discussions with other partners and just looking at some of the discussions we have ongoing. And then here, I'm quite transparent because I know there's a desire from our shareholders to get more information about what is going on. So I will flag that it's -- that we have advanced discussions. It's not necessarily meaning that all of these will lead into a contract. But now sharing some of the stuff that we are doing. So we do have quite advanced discussions with 2 larger health care providers in the U.S. with multistate operations. So these are also integrated health distribution networks, but on a much larger scale than Trinity Health in North Dakota. We have -- as you know, we are running a pilot study with a large tech company in the U.S. who have their first employees now using both vorvida and deprexis. We have similar discussions with a large -- actually larger than the tech company in terms of employees, industrial company, and they wanted to integrate to work with the insurance company also. So now we actually have a pilot project that we were discussing with 2 parts, which are both very important. One is the industrial company with quite a lot of employees and then it's the insurance company. And of course, getting an agreement with them would not open up for other employees, have another benchmark for employee contracts with employers but it's also important to get the insurance company involved because then we could go to other companies working with the same insurance company and do a similar agreement. Then we're working with one of the leading telemedicine companies in the U.S. within mental health. And there, we have been in quite continuous discussions for quite a while to develop a concept together where we are basically making access to vorvida, deprexis and potentially also modia over time through telemedicine across the U.S., a quite exciting opportunity, and I hope that will lead into an agreement relatively soon. And of course, we have continuous discussions with several individual clinics and hospitals. But just looking at all of these 3 larger integrated health delivery networks, that's multi-state operations, several hospitals, several units, it's larger employers, and it's larger telemedicines. And this is just some examples of the stuff that we're doing. So moving to Page #10. So why does it take so much time? So people have been following us know that Trinity Health in North Dakota is someone we have talked to since I think it was first in September last year and where we ran a pilot where we basically made deprexis and vorvida available for their employees free of charge as a response to the COVID-19 crisis. Based on that feedback from the employees, Trinity Health opened up for discussions with us during Q4 for a model for how they could offer these tools even to the patients within the Trinity Health, North Dakota network. When we have found a model, the next step is basically how can this be integrated into Trinity Health in North Dakota. And remember, this is mighty. You can say North Dakota is small, but it's -- they have within their network, they're treating 2.3 million citizens. That's our patients. That is actually the size of Stockholm. So we're talking about a system that is at the size of Stockholm in Sweden. And what they need to do is to first develop these treatment plans to see how are we going to treat patients so we have a standardized solution with vorvida and deprexis. They wanted to make sure that these solutions are also anchored and accepted by the main payers that they're using, so they don't have an issue with the payers when they come and ask for payment. They wanted to get the clinical staff involved to get their assessment of the tools to see if these are interesting. They needed to set up the internal billing processes because digital therapies is not an existing tool in most health care providers in the U.S. So they need to find a way. So how are we going to manage this in our internal system. And again, remember, our health care system, which is reaching as broad as 2.3 million patients. All of this work, then let when they got confirmed, they can get reimbursement. They've got positive response from the clinical staff. They found a way to set up their internal processes, and we have then been negotiating agreement with Trinity Health, and that was signed very late in the second quarter. We're now moving into the implementation phase and what that requires from Orexo is that now we have an open door. We know that we have a health provider in the U.S. who can get reimbursement for treatments where vorvida and deprexis is a part of. We now to make -- need to make sure that the clinical staff is actually offering these services to their patients. And that's something we will work with right now. That is, I was going to say, we're pushing it through the system into the clinical staff. But we will also, together with Trinity Health, we will create pull factors. We will work with marketing directly to patients in North Dakota. We will work with public relations, that's kind of working with the media to get attention about this unique treatment system. So while I can feel it's been taking a while, and I think our products are so well documented with the effects, it should be an easy decision to implement it, I also have some understanding of why does it actually take time to implement because there's a lot of stuff that needs to be in place for the health care providers. The good thing for us is that everything we have done with Trinity Health in North Dakota is something that will shorten this time line dramatically for the next partners that we're going to work with. So another partnership we have announced, and I'm now moving to Page #11, is Sober Grid. So who is Sober Grid? Sober Grid is the #1 online community for people struggling with substance use disorder. It's a global network. They have about 300,000 users. They are -- basically, the idea behind Sober Grid is to give people with substance use disorder, an access to information. They have a big network of what they call, peer coaches. So they're making -- basically, you can join the network and then you're allocate a peer coach who will help you in your recovery from your substance misuse. The partnership that we have -- we are seeing right now is a 3-phased project. The first one is that we will make our products now during Q3 available through Sober Grid's peer coaches. So these are people that are, I should say, if any one of you are becoming a member of Sober Grid, you will be offered a peer coach who will then help you in your recovery. They will now have an opportunity to basically promote vorvida and deprexis to the users of Sober Grid. The next phase is that we will make it available for all of the networks. So a lot of 300,000 people who are listed with Sober Grid are not at all the time active with a peer coach. So we need to find a way to reach out to these 300,000 registered users and then promote directly with them. The benefit, of course, working with Sober Grid is that we are reaching people who have a documented history of substance use disorder who have a -- who have searched for help before actively online, so they are open for online solutions. So our ability to promote our solutions to these users of Sober Grid, I think, is invaluable compared to other tools that we have been using. And then in the third phase, we are going to make a package solution where we integrate deprexis and vorvida into solutions that Sober Grid, with their coaching services, then can go and offer to other companies, court systems or similar in the U.S. So a quite exciting partnership and while it's been taking some time in the discussions with Sober Grid, it's also due to their assessment of the quality of the tools that we are offering and to get a partnership with someone who is a neutral observer into the market is very, very valuable for us as a reference point. Then finally, moving to Page #12. A big step for us is, of course, on the product where I would say that we started our entire digital therapies venture with was modia. So what we call OXD01 before we branded it. And modia is now going to be launched during the second half, late in Q3. It's a treatment for opioid use disorder. We will launch it initially under the emergency use authorization that we can get from FDA during COVID-19. We will then, based on the clinical trial that we just have started with 400 patients, we will aim to get, what's called, a 510(k) classification for the product, and that will -- long term, we believe, that would be beneficial for modia because modia is going to be an integrated solution together with the pharmaceutical treatment. And that way, we think this higher classification for modia is something that we should strive for. Of course, our real-world evidence study from Magellan will also be supportive in this for sure. So with modia, we are expanding a launch late in Q3, and we will have already started the enrollment of patients into this clinical trial. Moving into ZUBSOLV. And for ZUBSOLV, we have -- as I said before, we had a stable Q1 despite that we still see some of the COVID-19 challenges with difficulties to access the customers. We've also seen that the market for particular commercial is going down, which I think is very tightly associated with unemployment and economy in the U.S. But on the positive side, we have now seen Kentucky opening up in the fee-for-service Medicaid. So a little summary of the ZUBSOLV market development. So we have seen a year-to-date market volume growth that is lower than what we've seen in recent years with 8% growth. Most of this is coming from the public segment where we have seen a little more than up to 10% growth. But if you're looking at our core segment, the commercial segment, that's people who have a private health insurance, that commercial segment has only grown 3% year-over-year. And here, we think the COVID-19 and unemployment in the U.S. had a massive impact. But just looking ahead, we have, and this is where we come to some of the optimism, so there are new federal policies in place which are aiming at expanding access to treatment. The death toll from overdose that we saw coming last night is definitely something that is going to drive even more attention to the issue. We're seeing a lot of states are taking their own initiatives to drive treatment and improve access to treatment. We're expecting to see a lot of the ongoing opioid trials. That's basically the states suing companies who have been selling prescription pharmaceuticals with opioids and other stakeholders for the damages this has done to the state economy with a lot of people getting addicted. And they are -- already now, there are a lot of settlements, which will basically create a massive inflow of money into the system, which should be dedicated to improve treatment of those suffering from opioid dependence. So we have a market that -- growth that has gone down a little, but I'm quite optimistic that with all of the initiatives we are seeing with the improving economy in the U.S., declining unemployment, then we will see a rebound of the demand in the U.S. I had expected to see some of that already in Q2, but now we have seen a positive development in the second half of Q2, and that makes me optimistic for the second half of this year. When it comes to ZUBSOLV and our own promotion, we have had a challenge, like everyone else, to reach out to the health care providers, while we have seen now a nearly back to normal access to the clinics in the U.S., a lot of the physicians are less accessible, partly because they are working more with telemedicine so they're actually not in the clinic, partly because of either their own restrictions or imposed restrictions on access to health care facilities and health care providers. But we have -- basically, we're seeing more or less on a week-by-week basis, we are improving access, but we are not back to where we were before COVID. And here, again, local outbreaks of COVID-19 can, of course, change this picture relatively rapidly. For Orexo's part, I would just say one important part for us has been that our field force are all vaccinated. When you work with a pharmaceutical, I think that should come as natural. And actually now, I believe that all of our field force is fully vaccinated. Coming last to ZUBSOLV. I talked before, Kentucky. Kentucky is a big state from a buprenorphine-naloxone market perspective. So with the open access, we now have Medicaid in Kentucky, we have our public open access jumping from 34% to the highest number we have ever had, and that's 42% of the patients in the U.S. getting a buprenorphine-naloxone products prescribed today have access to ZUBSOLV being covered by the insurance. We are still the only branded product, which are covered by the top 3 U.S. PBMs. And positively, all of our market access for the second half, including these 3 PBMs have been confirmed for the second half of 2021. When it comes to 2022, so far, we have not seen any negative development, and we have seen quite a lot of our larger contracts being confirmed in terms of market access for '22. But again, here, market access and formularies are normally published for some of the larger players in August and September. So it will take a little while before we are certain that we will maintain the market access. But so far, it's a good reason for optimism that will keep our market access from '21 into '22. Moving to Page 15, and this is an illustration of the market growth. And as you can see, actually one of the reasons why we've seen less market growth in -- both in total, but also in the 2 segments we have here is because of the dip we saw in the first quarter of this year. So where we had a -- we normally see a dip in the first quarter, but this -- it was more accentuated in the first quarter of '22. And -- but if you look at the traction on from that dip, we're actually back to the same curves that we had before. So right now, the low -- less than double-digit growth is explained partly with the dip that we saw in Q1. And we're starting to see the market actually recover, and I think this is associated with the recovering economy in the U.S. Moving to Page #16, a little more breakdown on ZUBSOLV. And as you can see, it's relatively unchanged. We see in the open segment, a 0%, if you look across the quarter, change in demand. We saw the Humana and UnitedHealth Group is down by 2% and the non-reimbursed is down by 1%. If we go into the open segment and just look at the part, which is commercial, that's private health insurance, we actually grew that one with 1% and the total open grew with 0.4%, but we didn't include the decimals here. So all in all, I think we have a situation where our OX124 is moving forward, working with good progress in our development, just a few days away from the pivotal trial. Digital therapies, we have really taken a big step forward with the agreement with Trinity Health, North Dakota, which has opened up for new and bigger discussions with much, much bigger players than Trinity Health in North Dakota. And for ZUBSOLV, we're actually seeing that we're growing in our core segment, but we're still paying the price of the success we have before with Humana and UnitedHealth Group. And now when we're not exclusive, that is something that basically are continuing to fading, but the fade is declining for every quarter. And hopefully, soon, we'll see a stable situation in Humana and UnitedHealth. With that, I will open up for Joe DeFeo to take us through the financial information. Joe, please?

[Joseph DeFeo, Executive VP & CFO]

Good afternoon. I'll go to Slide 18. This is our quarterly sales. You can see that Q2 sales are down year-over-year due to ZUBSOLV. But as you'll see in 2 slides, we start to see good stabilization in ZUBSOLV. You can also see on this slide that our Abstral royalties continue to hold up well, actually doing better than last year. So there is some increase there. So overall, lower U.S. revenues, but you'll see that those are stabilizing. Next slide, Slide 19. This is year-over-year. This is -- actually, I'm sorry, this is -- this shows you right now the stabilization of our sales. The main thing you want to look at overall are the first 3 columns, which is the demand. You can see that our demand in the open segment has actually increased over first quarter. And the biggest decline is in UnitedHealthcare and Humana, the former exclusives, but you could see it's only 2% now. So we are definitely seeing that slowing down significantly and we're confident that these sales are starting to really stabilize. The wholesaler inventory, as you know, in Q1, we always see at year-end, there's a high inventory level. And then in Q1, we see a drop off in that. We did not see that in Q2. Q2 inventories have stabilized. We also did have 1 extra shipping day in Q2 versus Q1. That's in that column as well. The other thing is we had a small difference in returns. We continue to see -- we're managing our product very efficiently. Our returns rate is only like 0.2%. So we're -- we continue to see some good positive returns there. It's slightly less than Q1. The other thing is positive payer mix. Our price is favorable versus -- our mix is favorable versus Q1. We do have fairly consistent currency for quarter 1 and quarter 2. So there's really no -- there's no currency effect right there. So overall, down less than 1%. So good stabilization of ZUBSOLV in Q2 over Q1. Slide 20. This is our U.S. Pharma LTM, last 12 months. We continue to optimize our profits with U.S. Pharma. Our operating margin, you can see here, is almost 55%, and it's up -- it's been up there for the last 2 quarters now. And you could see that our profits overall have really been fairly stable profit levels for the last 4 quarters for LTM. Going to Slide 21. Here, our P&L. We talked about the revenues being down. Our COGS slightly favorable. We are more efficient with our ZUBSOLV production. In our operating expenses. The operating expenses overall are slightly up versus last year. That's due to a couple of things. They're down in selling expense. We continue to optimize our commercial expenses for ZUBSOLV. Where we see opportunity for growth or to maintain our sales levels, we continue to keep our commercial efforts. Where we see that the efforts aren't working, then we optimize and save some money there. That is offset by the -- obviously, the increase in spending in our digital projects to promote those brands, vorvida and deprexis. Our administrative expenses are higher than last year, and this is mostly due to our IP litigation and also the subpoena case in the U.S. Our R&D expenses are up as to be expected. This is predominantly due to OX124, which we're seeing good progress there. Our other operating income and then also our net financial items due to the exchange rate, there is some negative there. So overall, our EBIT was SEK 54 million (sic) [minus SEK 54 million]. Our EBITDA is minus 41.1%. If we go on to the next slide, Slide 22, you could still see that we continue to maintain a strong cash position that enables us to continue to invest in our DTx and OX124 and also some new development programs. Our liquid funds are almost SEK 700 million, and our net cash position is almost SEK 200 million. So still a very, very strong cash position, which we continue to maintain and monitor all the time to make sure we're able to continue to have a good, strong cash position. With that, I'll move on to the next slide, which Nikolaj can handle.

[Nikolaj Sørensen, President & CEO]

Thank you, Joe. And just to make it clear, I noticed there was a minus missing in the EBIT. So it's a minus SEK 54 million for the second quarter. But I would also say that a lot of [indiscernible] as we expect because we're investing right now quite heavily behind our digital therapies and behind our R&D expenses. And then, of course, we have, unfortunately, these legal cases which are costing a little at the moment. If you break it down by business unit, you will actually see that the U.S. Pharma is able to fully finance our digital therapies from where we are right now. Then we have an investment in our R&D activities, which is then taking us to the negative. But all of that is deliberate, and we could, of course, just decide not to continue the development of OX124 or significantly slow down our launch activities for DTx, and that would take Orexo back to a profitable position. But at the moment, we find these investments are more valuable. The other point I would make to the financial presentation is that it's -- last year, I believe the average dollar exchange rate for Q2 was SEK 9.6, now it's SEK 8.4. So the -- if you look at the sales number, the decline in sales, nearly half of it is explained by currency effect. And now, I just noticed that the dollar has -- that the exchange rate has changed a little again. So should it be today, the dollar exchange rate would have been SEK 8.6, I believe, so which would then have positive effect compared to the previous quarter. So on Page 23, we have our 2 cases and I am -- it's a little -- with very mixed feelings, but it's actually yesterday, we had our 1-year anniversary of the subpoena. And I must say that it's extremely frustrating because we have been forced to leave over a lot of information to the authorities in the U.S. We have invested quite a lot of money to have not only 1 but 2 external legal firms to go through the information that has been handed over to the government to see if there are any reasons for concerns. And we have still not found that reason for concern, but of course, to have external U.S. lawyers to go through everything to ensure we are prepared has been quite expensive and taking a lot of efforts from our U.S. leadership team, which could have been more effectively used otherwise other places. And still, we haven't heard anything more about what is the background? What are the -- are there any suspicions? Is this just an open, you can call, a fishing expedition. We just don't know. And that's very difficult for us. We are doing with our lawyers trying to find ways to get more visibility into this, so we can actually start to handle it if there are any concerns, but we have not been able to find the reasons for the subpoena and any concerns using 2 different external law firms. We then have our patent infringement litigation against Sun Pharmaceuticals, that one is following a quite fixed schedule. The positive part during the quarter is that we have 2 new patents issued for ZUBSOLV, bringing us up to 9 patents in the Orange Book. During the quarter, we have -- so the 2 patents we got in December, we have now started a case against Sun Pharmaceuticals that we expect will sooner or later be rolled into the overall patent infringement case. But now we have 2 more patents that we are still expecting, but have not seen any response from Sun on these 2 new patents. Moving to Page #25, our outlook. We have decided not to change the outlook as it is right now. We still believe that there are reasons why the buprenorphine-naloxone market will rebound. We did see most of the decline right now is explained by Q1. So we start kind of on a lower level, but we are on a same pace as we were before Q1, and we do think that a lot of the initiatives in the U.S. right now should help to move this market growth up over double digit. And we are also hoping and expecting to see the commercial market is also rebounding stronger. So it's not only the public market that will drive this growth. We have said before that we were expecting a normal seasonal decline in Q1 and then a stabilization, and that's what we've seen in our stabilization of ZUBSOLV and then when we see that the impact of COVID-19, both in the economy, meaning unemployment, meaning more patients to the commercial segment has evaporated, and we are able to go back with our field force that we can start to see some growth with ZUBSOLV. Our OpEx, we have said will increase. And as you've seen, we have done that. Our U.S. Pharma EBIT is expected to be around 50%, and we expect that that's no reason for us to change that. And then just looking a little ahead of some of the triggers that we could have. For the quarter, we did say that we will have agreements with insurance companies for DTx products. We last quarter talked about the Magellan agreement. This quarter, I'll just highlight the Trinity in North Dakota. They have actually gone out to their insurance companies that they are -- the top 5 insurance companies that patients going to Trinity Health has. They have gone to those and asked to -- will you reimburse these new treatment plants, which are including vorvida and deprexis and they got a yes, which is very positive because we can now go to other health care providers having the same insurance companies, which, for the most part, are not local to Trinity -- to North Dakota and say, we know that you can get reimbursed for these solutions. We have agreement with employers. So we have this large tech U.S. company, and we now have advanced discussions with another industrial company, and we have an agreement with a start-up company who is offering services -- telemedicine services to health care providers. They are in a start-up phase. But again, if they get more traction, then our services will be part of their offering. And then agreement with health care providers, we have talked a lot about that, and we have some with advanced discussions moving. Looking a little ahead, we still believe that ZUBSOLV will continue to stabilize. And if we see that the commercial segment starting to grow, we also expect to have a positive effect for ZUBSOLV and see better numbers from ZUBSOLV in the second half. Q4, we will have results from our pivotal trial for OX124, and we are expecting to see the launch of ZUBSOLV Europe by Accord Healthcare late this year. We are still on track. We had some issues with our packaging site in Romania due to COVID-19. But I think they are about to be solved, which should put Accord Healthcare on track to launch ZUBSOLV late this year. And then finally, we have our continued commercial progress at DTx. We are expecting to see some of the advanced discussions that we have right now will convert into real agreement and also that we have the launch of modia, which is now scheduled to the second half of September and then we will start, hopefully, see -- start to see some impact on that from Q4. With that, I will open up for questions, and thank you for your attention.

[Operator]

[Operator Instructions] And our first question from Samir Devani from Rx Securities.

[Samir Devani, Research Analyst]

I've got 3. I'll just go right through them. The first one is just on Abstral. Can you just remind me why we see quite a lumpy quarter-on-quarter variation with Abstral. And perhaps maybe if you could comment on the underlying usage of the drug and whether it's still seeing growth in the market? Second question, just on modia. It's good that you're doing the comparison to standard treatment. I was just wondering, looking at the trial design, why you decided to use change in opioid use and not abstinence? And is that the key time point there 24 weeks? And then the final question, you mentioned the importance of having a 510(k) for modia. I'm just wondering what are your plans for vorvida and deprexis for a 510(k)?

[Nikolaj Sørensen, President & CEO]

Okay. Thank you, Samir. So I will answer this. On Abstral, one of the reasons for the lumpy variations is that Abstral today, all of the sales is coming from distributors in -- which are not in Europe or in the U.S. because there the product has lost its exclusivity, and our contracts have been terminated. So what we are seeing is that some of the distributors are late in reporting so -- and some of them even have a different time schedule for the reporting of sales, which basically means that we -- in some quarters, we get historic adjustments when -- with the right numbers are coming in. Also for some of them, they are doing estimates for the quarter, just like we are forced to sometimes; for example, this quarter, we need to do a little estimate on the latter part of the quarter because we have a short time window before we are reporting. And the same is for some of these when they report the royalties to us, which we're putting into our report, then we can come into the next quarter when they have actually done an audited review of the sales. They need to do a little adjustment on that. Then when it comes to modia, why do we compare -- why don't we use abstinence as a trigger? One reason is because the modia trial is basically a combination with a buprenorphine-naloxone treatment. So patients are, by definition, on an opioid while they're treating. And what we are looking at is illicit drug use. So we want to -- and you can say the abstinence in this case is abstinence from using other drugs than buprenorphine-naloxone. So we are -- the primary endpoint is reduction in illicit drug use compared to the standard treatment, which would, for these patients be a noncounseling buprenorphine-naloxone prescription only without any counseling associated with that. And the final one is why don't we see 510(k) for vorvida and deprexis. Part of that is for vorvida is that we see that vorvida is much more -- or alcohol use disorder treatment in the U.S. is much more of, you can say, a wellness product. It's treated outside established channels. So for example, Sober Grid are using peer coaches in the treatment. We see a lot of AA groups and similar in the U.S. It's rarely treated in the doctor's office. And if you have a 510(k), you actually need to get involved with a health care professional. So you need to ensure that the patients are seeing a health care professional in the process. And here, we see that alcohol misuse is not in that category. For the practice, it's more of a border line, but the practice actually has a 513(g), and that is -- the marketing authorization holder is GAIA. So deprexis has been set up in a way that is a 513(g). And we haven't really seen any negative impact from that. Right now, with the 513(g), we have a little more, you can say, freedom in the way that we could promote it. But at the same time, we have a limitation in what kind of claims we can promote the product on. So that one can be debated, but it was approved or kind of a classification by the FDA on the 513(g), and it is GAIA, who are the marketing authorization holder. So right now, there are no plans to have an uplift for these products.

[Operator]

And the next question comes from Gergana Almquist from Redeye.

[Gergana Almquist, Equity Analyst]

I have a question about the launch of modia. And more specifically, what impact do you expect on the ZUBSOLV sales, if any, when modia is launched?

[Nikolaj Sørensen, President & CEO]

That's a good question, Gergana. So we -- it's an interesting dynamic. When we're talking to payers about our digital therapies, I can say that while we have focused on vorvida and deprexis, the second modia comes up, the discussions tend to focus on modia. I think that's partly because of the significant lack of counseling services for opioid use disorder and the escalating expenses associated with that. And interestingly, a lot of them are also coming back and say, we would like to see are there any solutions we can have with a combination with ZUBSOLV. So we are working with different ways where we can combine ZUBSOLV and modia directly to the patients, even though we do see a quite large market for modia, which is not ZUBSOLV only, but we think the combination will enable us to provide new services to both payers, prescribers and patients. So I would expect a positive effect from modia. And in particular, I think we would have an opportunity to make more larger agreements with, for example, larger health care systems, like the one we have for vorvida and deprexis with Trinity Health in North Dakota. We could have something similar where we combine ZUBSOLV with modia for health care providers. So I can't give you an exact number, of course, but my guidance would be that we would have a positive impact from modia on ZUBSOLV. And if we're successful of finding ways where we can see the 2 complementing each other, I think it's the right word because we won't have a combination product, but to have a complement of the 2, and that would -- could give a good boost to ZUBSOLV also.

[Gergana Almquist, Equity Analyst]

And the second question is about the OX124. How do you expect to profile it in terms of unique selling proposition compared to the other's price available on the market? There is also as presently launched with stronger doses of...

[Nikolaj Sørensen, President & CEO]

Yes. No, I think the one from -- the one that is -- was called KLOXXADO, I think, from Hikma.

[Gergana Almquist, Equity Analyst]

Yes.

[Nikolaj Sørensen, President & CEO]

I don't think it's launched yet, but it's definitely be launched before we come out with OX124. Our expectations is to go out and show a product with a significant -- a very fast uptake with the -- in the PK profile. And with that to be able to promote a stronger effect than the market leader today, NARCAN. How it looks compared to Hikma's products, we don't know because we haven't compared the 2. But we think there is such a big market outside. So we should be able to promote this with -- there are space based on the PK profile we get to promote this to segments where there are concerns about fentanyl usage. And I think the main argument we'll have will be associated with the PK profile and how we can compare that to particularly the market leader. And then I think our network that we already have with ZUBSOLV into a lot of people who, by definition, are seeing people with opioid misuse issues will help us in the launch also compared to other players.

[Gergana Almquist, Equity Analyst]

And then I have a question about -- you mentioned you're testing the spray also with other areas with other active substances. Are they in the same area of mental health and addiction? Or do you consider expanding to other areas?

[Nikolaj Sørensen, President & CEO]

Both, I would say. So we -- the way that Orexo has been operating in our R&D for the last 8 years, at least when I have been in the CEO has been to try to solve specific issues we have identified in the market and not gone with the technology. But of course, when the technology exists, and we have a broad patent protection around the technology, we go the other way around. And right now, we are looking at the C spaces where we have a need for something where you have a fast uptick, something that -- where we can have a pricing that is motivate a combination product with a device and areas where the API fits into the formulation work we have done on a OX124. And based on that, we're basically looking very opportunistic on what other APIs could work. And here, we have both APIs within the mental health space, but we also have APIs, which are completely outside the mental health space. I do think that some of the APIs we are looking for would not be Orexo to take all the way to the market, and we would probably seek a partner when we have the first clinical data from early trials.

[Operator]

[Operator Instructions] And our next question comes from Josefine Persson from Nordea.

[Josefine Persson, Analyst]

So FDA announced a budget request by the end of May to address complex challenges facing the country, such as the opioid crisis. And they were, in particular, mentioning digital therapies to resolve this and they have a funding of USD 2 million to advance the development and evaluation. So my question is what is your view on this? And will it help out with the reimbursement challenges and so on?

[Nikolaj Sørensen, President & CEO]

I think for FDA, it's a little disconnected from the reimbursement, but I think they have identified an area which is -- it's basically you have a -- if it hadn't been for COVID, you have a catastrophe on their feet at the moment with the opioid misuse epidemic. It's -- I think it's something that just needs to get attention from everyone in the U.S., all the way from the federal level, FDA to the insurance companies. And I think the view is right now from FDA, which is positive, is to see that digital therapies actually has a space to play. And I think when they open up for that, you suddenly have an opening for other units within the government to see, okay, how can we find ways to help the reimbursement process. And that's not saying to get reimbursement, but actually to find systems, how should we code the digital therapies? How should we use them and can set up infrastructure to ensure that they are easy to manage both from patients, payers, prescribers and of course, from the companies? So that recognition that digital therapies has a space in the treatment paradigm for opioid use disorder, I think is very, very important and will help us, maybe not directly in the dialogue with insurance companies, but to put up all of these systems that simply is lacking. And that is something that -- I were a little too optimistic last year that due to the COVID-19 crisis and the need for these products that there would be a more willingness to cut corners and find solutions, which would be interim. But a lot of the health care providers and insurance companies we're talking to, they are basically lacking this consistent system across all digital therapies where they can easily categorize them, easily find a way to recognize them in the system and to put reimbursement codes on that. And that, I think, is better solved on a federal level than by the insurance companies and health care providers individually. So I'm very happy to see that there's that focus from FDA. And I think it also helps us at least dialogue we have is to see that the emergency use authorization, we are launching modia on is not likely to be removed in the short term.

[Operator]

Thank you. And as there appeared to be no questions, I will turn the conference to the speakers for any closing remarks.

[Nikolaj Sørensen, President & CEO]

Thank you. And now just so we have online received 2 questions. We have one question is what is the decline in ZUBSOLV earnings and local currency adjusted for shipping days? And here, I think Joe was mentioning that we do have -- in Q1, we had 2 less shipping days compared to Q4. This quarter, we have 1 more shipping days compared to Q1. And that 1 is partly reflected in this wholesaler inventory, where you saw it jumped up in our graph. And looking at that, you can have a decent view on the impact of the shipping days. On ZUBSOLV -- the other question I received was ZUBSOLV in Europe. And that one, I think I addressed when I talked about the progress we're doing with Accord in launching Southern Europe late this year. And also, there was a question about modia. And I interpret the question received that it's modia also for Europe. And here, we have started a process to review the regulatory opportunity -- say, frameworks across Europe, reimbursement opportunities for modia to make a decision later this year, which country should we start on and how should we proceed with Europe? Should we do it independently and just being Orexo? Or should we find partners in different countries? Today, modia is only programmed in English, and it's done for Americans. So if we're going to Europe, we would need to invest somewhat in changing the language in modia. But we are looking at that, and we have global rights to modia. So of course, this is something that we are very interested in is to find new ways of broadening the impact of modia. And With that, I will thank all of you for taking your time to listen to us during this very hot summer day in Sweden at least, and I wish all of you a good summer, and hopefully, 1 year on vacation, if you're going to that, I hope you have your eyes open because I think there will be some good news coming from Orexo as we proceed. So thank you a lot for your attention, and have a great summer. Bye.