Orexo AB

STO:ORX

Earnings Call Transcript 2023-Q2

[Operator]

Welcome to Orexo Q2 Report 2023. [Operator Instructions]Now I will hand the conference over to CEO Nikolaj Sorensen and CFO Fredrik Jarrsten. Please go ahead.

[Nikolaj Sørensen, executive]

Welcome to this second quarter and half year result presentation from Orexo. This presentation, we have deliberately kept a little shorter than we used to, and it will focus solely on the result in the quarter rather than being a broad introduction to the company. So for those of you who are new to Orexo and want to learn more about the company, I would ask you to visit our homepage to listen to previous presentations. And of course, when we come into August, there are several presentations scheduled, so you can get a more deep understanding of the company.So the second quarter for us have been a real turning point for the company on several different parameters. And for me, it's the -- I would say the first stepping stone in our return towards profitability, in our return to a more long-term strategy for where we can expand on some of our key operational areas like our commercial operations in the U.S., but also in our pipeline. And I'm looking forward to show the presentation and the results for all of you.So I'm joined today with Fredrik Jarrsten, who will take us through the financial section which will actually be the dominant part of this presentation, but I will first have a few comments on our key achievements of the quarter, a short business update. And then I will end the presentation with some comments about our future value drivers and what we expect for the next half year.So our key achievements, no doubt that the #1 for the company is the win in the New Jersey district court against Sun Pharmaceuticals to ZUBSOLV. We're very pleased with the opinion that had been published by the judge and of course with the result, where all of our claims were found valid. And Sun was found to infringe on all of the claims that were subject for assessment in the court. So this is really important for the company. It has been a significant overhang both on the share price creating uncertainty, but of course also for management. It has required a substantial amount of time that we could have used for other areas in the business. But now with the district court decision behind us, we look forward to have a more long-term perspective and also to have a more focus on the key aspects of the business, which are not legal.So on the financial results, I think it's interesting to see that we're basically improving our performance on all financial KPIs. The one number that is maybe a little negative is on cash flow, but Fredrik will come back and comment a little more on that because it's all working capital changes. But when we look at our net revenues, our OpEx, and our results, this is better than what we have reported in the previous quarters and last year and we see that we are in a good progress on both stabilizing our net revenues, in particular from ZUBSOLV. We are -- despite the strengthening of the dollar the last year, we have managed to keep our OpEx down. And that of course result in positive impact on both EBIT and this time we had a positive EBITDA, which we have known and the companies within reach and we're very happy to see that we're actually crushing the [indiscernible] line this time.On the pipeline, made some really good progress. We had of course a setback earlier in the year, would always want to fault not being accepted to file by the FDA. But we are now on track to submit in Q3 as we have guided previously. And then we are in some good, very constructive discussions about an OX640 partnering process. These partnering processes are very comprehensive in terms of both negotiations and due diligence. So these are long processes. There are a lot of aspects that needs to be agreed and be reviewed by the different parties.So moving into our commercial progress and ZUBSOLV where we have seen this modest continuous decline since our main competitor Suboxone Film lost exclusivity back in the middle of 2019. We have now seen for the first time that we have -- since 2019 that we're actually growing ZUBSOLV quarter-over-quarter in U.S. dollars and in demand. It's not a lot, but it is a growth and it's actually positive growth in all of the key segments that we're looking at the open business where we are fully reimbursed and the non-reimbursed, so that's where Orexo and ZUBSOLV has not received attractive reimbursement by the insurance company. And also within United Health Group and Humana which have been the main anchor or do we say the main cause of the decline that we've seen in previous quarter. But this time we actually saw a slight positive number in United Health Group and Humana.This is based on a market growth which is actually quite similar to what we've seen before, otherwise you could expect it to, when we see growth, that's because the market has been the locomotive for sales. But this time we actually very close to grow with a relatively modest market growth of 2% versus Q1, we grew with 1% which is a little slower, but still fairly close to the development since the first quarter. And in the light of this, you need to know that the segments that are growing the fastest, that is the Medicaid segment. And in Medicaid, we work 47% coverage. We had 47% coverage in the first half of this year. So that means the 53% of this market is not really accessible to ZUBSOLV in any major volumes. We are now improving that to 50%, which is quite an accomplishment based on -- we are facing severe generic competition. So we're moving from 47% to 50% coverage in the public segment. And in the commercial segment we're maintaining our former levels of 98%, so very close to all patients with a private health insurance have full access to ZUBSOLV.When we look at some of the progressions that we've seen in -- in reimbursement in Medicaid the space last year. If we look at New York, for example, we have a 64% year-over-year growth compared to last year and Kentucky it is 46% growth. So we've continued to see strong growth when we're added to the formulary. Now gaining more broader access in Indiana. We also expect that that will help us to drive further growth. This time the main growth driver for us has been Michigan Medicaid, where it grew with 8% quarter-over-quarter, which is quite an accomplishment again because in Michigan Medicaid, we haven't seen any changes between the quarter. So this is, you can say, pure growth based on good sales work from our field force.On the overall market, as the market growth is down into the single digit. That's something that is aligned with our guidance, even though we have some expectation that we'll see an acceleration of the growth. And the main reason for that is that we have a new legislation in place from earlier this year where all physicians have an easy opportunity or would be expected to have the license to prescribe buprenorphine/naloxone products as everyone prescribing a controlled substance in the U.S., when they renew their license to prescribe controlled substance, which includes sleeping agents or the pain medications and so forth. They will also automatically have a right to prescribe buprenorphine/naloxone product, that means ZUBSOLV and competing products.We also expect to see increased funding from settlements in opioid litigations. That's something that is starting to come up now in most states, like everything, on a state level or federal and states. We are seeing some bureaucracy about that for how are we going to divide the money, but we start to see more and more calls where companies can -- companies and clinics can apply for grants to improve access to treatment. And we expect some of these initiatives will convert into more broader access to opioid use disorder treatment. And of course, behind all of this, I think most importantly is that we continue to see a rise in opioid use disorder and in particular we see the number of people dying in overdose also continue to rise, not as dramatically as we've seen the last few years, but we actually continue to see an increase in overdose, so there is a need for improved treatment.What we're also seeing unfortunately that some of the rise to the OUD problems and in particular overdose is the fentanyl crisis. And as we've talked about before, people who are addicted to fentanyl are more difficult to treat. They're much more relapse, it takes longer time for them to get into more stable setting. And we're seeing that with shorter average -- with more relapse, that means shorter average treatment time and that of course have a negative impact on the market.We also see that this new legislation is not fully implemented and there are still some uncertainties what are the rules for new treatment, physicians who wants to treat? But we have seen a quite rapid increase in the number of physicians who are -- who have access to treatment, but not that many of them have started to prescribe in any major volumes. And that should be compared to what we saw during COVID-19 is access to some of the more high prescribing physicians of more elderly age have disappeared from the market. So we have seen some attrition of experienced physicians during COVID-19.On our digital therapies, that's the one area where we haven't seen that much of progress commercially during the quarter. And the reason for that is what we shared in the first quarter is we have actually stopped our commercial efforts right now. We have been forced to pull back to see how can we improve the reimbursement and distribution model. We did develop a model and we did develop a system that works, but we also have to realize after feedback from physicians that this is complex, it takes more steps than what they appreciate and we need to find a more simple way. Also from an Orexo perspective, we -- the system that we built back in 2020 when we started was built quite fast. We had to use some quite sizable suppliers. And the price tag on this is way too high to what we can afford and find this feasible for the size of the business at least in the short term. So we've basically pulled out of the existing suppliers and during the Q2 we've moved into new suppliers which are much -- where the price is much more aligned with the volume rather than a fixed price tag. That contract was not possible to exit before July 1, but now we have passed July 1 and we have managed to move the system into a different supplier in the U.S.One of the areas that we have a lot of focus on is on the Veteran Affairs and here we have worked with the Veterans Affairs to find a simple solution. To setup a complex solution is not that difficult, but with the knowledge that we have from Trinity Health and from other accounts who are trying to get the reimbursement model to work, we knew we had to find something that is very simple and is aligned with what the physicians and healthcare professionals use today. We believe we have the solution in place today where we're leveraging our online storefront where you could purchase access to the -- or you can still purchase access to our digital therapies. But we can actually use that and convert it into that Veteran Affairs can access the programs or the practices through that channel, which we think is quite exciting for that because that will work on a nationwide basis, but have required adoptions of our storefront and also actually all the way back and into GAIA who have been very collaborative in setting this up.We will now, to avoid taking on the same kind of commercial spent that we have seen previously, we will focus our efforts. So we want to see that we have proof of concept before we start investing broadly again, and that is on MODIA clinics where we will test with MODIA clinics that we know that several of them have been using MODIA now as a standard of care during our test program, modiaONE, and they will of course be the frontrunners when we have the reimbursement distribution system in place that we know will work. We have our MATCore concept where we're leveraging the grants that we have in the different states, the one that I have talked to on the previous page, where we see that there's an opportunity for us to actually get paid, why we develop and test an approach together with clinics in different states in the U.S.And then we have both deprexis, but we're also looking now that vorvida have received a formal registration with the FDA to put vorvida into the VA. So we'll have two products within the VA. That is subject for negotiations. But we know when we talked about deprexis with the VA, they were quite positive to vorvida. So we are optimistic that we can make that happen.And then with Trinity Health, there have been a lot of personnel turnover and they have not been as fast paced in the implementation that we want to, but we also realized that the reimbursement process that we setup together with Trinity Health is too complex for the physicians. So we need to reinvent that, building that on a new and more simple model. And we're working with them on that. But it has been moving slower than I would like with Trinity Health.We still find that digital therapies is attractive, but it is a more long-term opportunity than what we anticipated in the beginning. So now there's a lot of focus for us to reduce…[Technical Difficulty]

[Nikolaj Sørensen, executive]

Okay. My apologies. But I was disconnected from my end. So I will just shortly recap on some of the DTx comments that I made here.So where we are right now is that we are focusing our business to reduce our expenses. Our expenses today that you see under DTx arm for the majority actually allocations from our U.S. pharma business, because right now we don't really have -- we have 2 dedicated people working with DTx. The rest are not working with the upfront, predominantly working with U.S. Pharma, but there are some of the expenses allocated to DTx and we have a lot of depreciation also in the DTx EBIT number. So the direct expenses today are actually quite low on DTx.Then moving ahead, we are coming into our products under development. And here we are seeing a good progress with amorphOX. We are running some feasibility studies together with some biopharmaceutical companies. And we have the first data from the first formulations where we actually see that these APIs, the biomolecules remain active after being formulated with amorphOX and that's the first real stepping stone is whether to see these biomolecules are negatively impacted by being formulated in the amorphOX formulation process. So now we're working with the partners to see how this could impact bioavailability and also a little longer-term stability. But the first step has been successful on all of the biomolecules we have tested so far.OX124, we have solved the packaging issue, at least we have solved it in a way that we -- when we are running the first test, it's working and we don't see the issues that were seen before. But before we can file with the FDA, we need to run what's called a formal qualification process where we're basically testing that the packaging process is living up to the reliability data and quality that is required by the FDA. Those tests are running right now. But of course, we have run several tests before we're running the formal test. And we're very optimistic that we will keep our timelines and submit in Q3.OX640, we had some deep discussions with the potential partners and we are in the absolute last stages of due diligence. So now we are in July and not only Sweden, but also other countries, there are some vacation days to take into consideration. But I can tell you the Orexo team is working throughout the summer to ensure that we're meeting the due diligence request from the partners and to finalize and the negotiations with potential partners.With that, I will leave the word to Fredrik to go through the financial and legal questions.

[Frederik Jarrsten, executive]

Thank you, Nikolaj.So on Page 13, look at our revenue. Total revenue in Q2 of SEK 158 million, approximately 7% higher than in Q2 last year, SEK 148 million. And of that revenue obviously ZUBSOLV within U.S. Pharma is the main contributor with SEK 145 million for the quarter, which is up 4.1% from SEK 140 million in Q2 last year. So the main explanation for that growth, as Nikolaj elaborated on, is strong appreciation of the U.S. dollar. And for the quarter that effect was SEK 9.4 million compared to last year.Within gross net items, we also had a positive effect from lower wholesale and destocking of SEK 5.2 million. Now these positive effects were partly offset by lower volumes year-over-year, 4%. We had an unfavorable payer mix following the increased share of Medicaid sales as well as a negative gross to net reductions. In local currency, ZUBSOLV net revenues year-over-year declined with 2.6%.If you look at the last column, we included actuals for Q1 2023 this year. So you can see that compared to last quarter, ZUBSOLV net revenues grew 3.6% or approximately SEK 5 million. That reflects positive development of growing ZUBSOLV volumes now again with 1%, a very promising development. Net revenues was also positively affected by lower wholesaler destocking and to a minor degree this quarter from a stronger U.S. dollar. So in local currency, the ZUBSOLV net revenue increased quarter-over-quarter by 2.8%.Next page. So we are very happy with the development over the quarter, basically on all aspects of the P&L. I just mentioned the growth in total net revenues for the quarter. For the first half of the year, that growth is 3.1% at SEK 317 million. The COGS for the quarter is SEK 4 million lower, to a large extent a result of favorable U.S. Pharma production costs of the ZUBSOLV. And then when you look at our operating expenses, as we have talked about, we have significantly lower OpEx compared to last year of SEK 26 million, ending up at OpEx of SEK 153 million. And that's following lower expenses for IP litigation and the preparation for renewed filing of OX124 with the FDA. And also we introduced more cost-efficient processes within DTx, we have lowered direct expenses significantly by 40% since last year.Now the decrease in OpEx was partly offset by a negative impact of the stronger U.S. dollar by SEK 9 million approximately. The total effect of the stronger U.S. dollar on EBIT is, however, marginal since revenues and costs in total are balanced. So we can match USD costs versus revenues. And that is an important aspect that we're not being affected bottom line dramatically by changes in the U.S. dollar FX rates.Our U.S. pharma business shows again a good quarter with SEK 71 million in EBIT, which is a margin of 49%. Now that's down from 55% last year following mainly larger selling expenses, reflecting increased volumes and effects of a stronger U.S. dollar. So we're happy to report a positive EBITDA for the quarter of SEK 5.6 million. That's an improvement by SEK 38 million year-over-year. If we also exclude these non-repeating expenses, that will result in an EBITDA of SEK 30 million for the quarter.In financial items, net financial items, we have an unrealized FX impact of SEK 5.3 million on our cash held in U.S. dollars. We also have higher costs for the corporate bond of SEK 9.3 million. So that follows an increase in interest rate, partly offset by earned interest on cash and short-term investments of SEK 1.5 million.On next page, we just wanted to highlight the point we usually make, Orexo having a positive EBITDA if we separate what we define as distinct external non-repeating costs. For Q2, as we showed, we have positive EBITDA even when including non-repeating costs. And here in the waterfall graph, if we look at H1 numbers, these non-repeating costs amounted to in total SEK 87 million and our EBITDA within that case be positive SEK 51 million. So these external non-repeating costs, they relate to the conclusion of the clinical trial for MODIA, the preparation for the next phase of the OX640 project and the process for the renewal of the filing of OX124 as well as costs for the legal processes, which was the IP litigation and the subpoena. Now these costs will decline in the next quarters, especially with the win in the IP litigation and the completion of the MODIA trial. And the cost for resubmission of OX124 is expected to materialize in Q3. So this core EBITDA, excluding non-repeating costs, key metric confirming our route to returning to profitability and the progress of having a balanced EBITDA in H2.Moving to the next page on cash flow. We can see that liquid funds, that's cash and cash equivalents, that amounted to SEK 251 million end of Q2. That's a decrease by SEK 28 million from end of Q1 this year. So cash flow from operating activities, that was negative for the quarter with SEK 12.7 million. That was primarily impacted by negative changes in working capital related to a decrease in current liabilities. So we actually had a positive operating cash flow before changes to working capital of SEK 2 million. We also had investment activities that had a positive impact of SEK 121 million from the maturing of all of our short-term investments. Financing activities had a negative impact of SEK 40 million, and that's primarily from the buyback of the corporate bond. We acquired nominal value of SEK 8.75 million this quarter.So going to the next page on financial outlook. Group OpEx, sorry, we reaffirmed 3 out of 4 metrics, but the group OpEx has been revised following the significant decrease in OpEx in H1. Our previous metric was that OpEx in H1 will be slightly higher than in H2 2022 of SEK 385 million, but actuals in H1 came in much lower at SEK 343 million, including depreciation of SEK 37 million. So with this development of decreased OpEx, we feel confident in having an outlook on OpEx for H2 being lower than in H1.And with that, Nikolaj, I leave for the legal update.

[Nikolaj Sørensen, executive]

Thank you. So the first one I already mentioned a couple of times. So we have one in the District Court of New Jersey. It came 6:00 local time U.S. on June 30. So right after midnight Swedish time on July 1. We today have 10 patents listed in the Orange Book, and we were quite pleased to see that the patents and claims that were up in the District Court have all been validated. And we now have patents expiring from December 2027 up to September 2032. There is, of course, a risk that Sun will appeal the decision. But based on the opinion, which is very well motivated, 83 pages of opinions, we find that we have a very, very strong case should this be appealed. But in an appeal process, I'll also just say that the expenses for the company is a fraction of what we have seen in the District Court. It's a much more simple process and no new evidence should be produced into such a process.And we also have our U.S. authorities' investigation of what we call the subpoena. It is interesting right now that we actually have our 3-year anniversary, and this had happened just around our Q2 report in July 2020, and we haven't really seen much progress in this. There are still sporadic questions and dialogue between the lawyers and the authorities, but we haven't come into any formal conclusion or even close to a formal conclusion in this process.So what can you expect moving forward? So on a -- we are seeing that our corporate EBITDA profitability is in sight. And just as Fredrik said, we are looking at some of these nonrecurring expenses. As long as we're holding them back, we are actually in a profitable position on the EBITDA, and that would actually even convert into positive EBIT. However, there are some expenses coming in here in Q3. For example, we have the refiling of OX124 with the U.S., which is costing a couple of million dollars. So there are some cost expenses also coming into the second half. So right now, we have an ambition to have an EBITDA balance during the second half.On ZUBSOLV sales, I'm very pleased to see how we have stabilized and that seems to continue with a few data points we have into the third quarter also. So that's something that we are feeling confident that we can maintain a good ZUBSOLV trend on a stable level. I think we need to see more market growth to see ZUBSOLV actually take off, but that we can probably start to see that we don't have this melting ice cube that we've seen in the last few years that we have found a more solid ground. I think that is very strong indications for that so far.Our R&D pipeline, I think, is something that we are looking to have revenue-generating partnerships in place during this year, and then that's in particular for OX640. Some of our other studies that we're doing in these feasibility studies, they are more R&D focused, so they will take a little longer time to convert into actual financial partnerships. But we are getting coverage for some of our expenses in these programs by some of the partners.And then we have our digital therapies where we are into a -- you can say it's unfortunately a very immature market, and there are a lot of material that needs to happen. But I can say just before I entered the room here, I received an e-mail from the U.S. where the CMS, Center for Medicaid Services, on federal level have requested information about what is needed to create a reimbursement system with digital therapies. So at least there is an interest on a national level in the U.S. to find a solution, and they are asking stakeholders just like Orexo, what are some of the hurdles that we've seen for providing access to these tools for patients within the CMS. So there are some hopes, but it has taken longer time. But normally, what you're seeing in other disease spaces is that CMS, when they introduce a process, then often you will see other insurance categories like private health insurance to follow-up into the same category. But it will take time. And we haven't seen the urgency we saw in 2020 when we started this, has not converted into strong solutions. But I think there are a lot of good momentum, but we need to have a little more patience than what we expected from the start.And then on the Sun litigation, we have received the decision, of course, now during the quarter. So I think it's -- we are at an exciting turning point for the company, and I hope our self-confidence and optimism can -- is something that you can share. And at least, we are quite proud about the results we have accomplished during the second quarter, but we are far from done. There's a lot more work to be done, and we are in good progress, but we continue fighting.With that, I will open up for questions, and thank you for joining this call.

[Operator]

[Operator Instructions] The next question comes from Samir Devani from Rx Securities.

[Samir Devani, analyst]

Congrats on a good quarter. I guess, I've got a couple of questions. Just thinking about, you focused a bit today on sort of nonrecurring legal and clinical trial costs. I guess it's got me thinking about what your strategy perhaps for 2024 will look like. Are you signaling that you're essentially not going to undertake clinical trials directly now and that we should think of things like amorphOX has really more to do with the partner taking on the bulk of those expenses? And if that's the case, what would be a sort of baseline R&D spend in that scenario? So I guess that's question one.And then just thinking about MODIA, obviously, we've got some data coming. And again, today, you've spoken about changes in terms of a more efficient system and so forth. So I'm just wondering, has that changed your approach in terms of potentially filing for a sort of regulatory approval there? How has that evolved now?

[Nikolaj Sørensen, executive]

So on the nonrecurring clinical cost, I still think there will be nonrecurring expenses, but it's much more in our control. But I do think given the overall stock market, the sensitivity about financing and of course also Orexo with a negative net cash position because of the corporate bond. I think short-term profitability is of more importance to us. And that spill into some of the partnership discussions we have, where we would see that the partner is taking at least the majority of the expenses moving forward.Then you come to our own pipeline. And of course, we have ideas in the pipeline. But a lot of the ideas are in, you can say, the first early stages are not so expensive. So there are opportunities to progress programs in the company before we reach the more expensive clinical trials. And I would say, if we should start on an amorphOX project today with formulation and you need to have some stability data, you might need to have some animal models also before you move into human studies. If we start a project today, we won't see clinical trials before earliest end of next year, maybe even into the next -- the year after. The ones that are closer are OX125 and OX640. And they are -- both of them, the next step will be an increase in commercial scale for the manufacture -– into commercial scale of manufacturing before we can run the studies, which would push the studies into next year. But I think with OX640, we are looking for a partner to take the responsibility for the clinical trials. OX125, it's really depending on how some of these other partnerships development are and, of course, the overall financial situation of the company.With regards to what is the R&D expenses. I actually think you can little backtrack that looking into some of the expenses we have today and look at how much we are in -- I think in the slide here, we're presenting how much expenses that were associated with R&D. And that give you some sense of where we are from an R&D perspective as a base case. And I think in that number, there are -- we are moving on other APIs. We are submitting new patent applications for other APIs on amorphOX, which is not part of the nonrecurring expenses. So there are definitely room for activities even if we exclude those.Then on the MODIA data, you're right. We are waiting for the clinical trial results. This study has been finalized. This study has the advantage of you both have the aspects of the traditional pharma product trial, where we're taking bio-samples out of the participants in terms of urine screens. But we also have a digital site where they're actually using a digital program. So now we have to merge the data from GAIA with the data that we have received from the CAO, and that will give us the end data that we could look into.How that will impact the approach in terms of regulatory approach? We have been looking at a 510(k) from the start, but you could say that the 510(k) focused companies, in particular, Path Therapeutics have not been successful in this space. And there is, of course, a question, is there a need for 510(k)? Because with the 510(k), you also have a -- there's a much higher regulatory burden. It's much harder to -- that's much more, you can say, controls of how we can promote the product. Even though you can come with some treatment claims, it also come with limitations on how you could adopt the product as you're moving along. But again, this is premature to focus on. But I do think on the DTx side, you have to weigh in both clinical data results, but also how the market evolves and what's necessary to receive reimbursement in the market and to receive utilization.And so far, these prescription digital therapies, we don't have any examples of someone who have reached volumes in the U.S. Where we have seen more successful uptake of digital health, that's when the digital health solutions have been integrated into the health care provider's care programs. And that way received reimbursement indirectly from being a part of an integrated care program at the health care provider, which is different from actually having a prescription product. So there are a lot of aspects that we need to take into account right now. And we are looking actively at that. But of course, the clinical trial results will inform us somewhat of the right move forward.

[Samir Devani, analyst]

And then maybe just if I can add one more. What sort of prelaunch activities are you planning for 124?

[Nikolaj Sørensen, executive]

So OX124 is also a quite interesting market, and we will see how we will share our going to market strategies a little later in the autumn. But the market is very interesting and dynamic at the moment as we are just about to see the first OTC products entering the market. And that will inform us about, so will the generics on NARCAN, will they follow into the OTC category? How will the reimbursement landscape move? And of course, we have Kloxxado, which is promoted, not that active, but is promoted by Hikma. How are they faring? What segments are they moving into? So what we are doing already now, you can say what OX124 is that when we are talking to payers in the U.S. about our complete OUD program, where we have MODIA, we have ZUBSOLV. We are also talking about the pipeline and what we are doing in the pipeline and discuss how they could be integrated into that solution because I think, in particular, OX124 lend itself for more creative distribution models where you're finding bigger partners who purchase larger volumes and distribute them to the end games.For example, some of these grants that are out right now. I think there are good opportunities to integrate OX124 into some of these grant concepts. And you can say, so what is a grant? Can you really build a business on that? I don't think it will be a long-term sustainable business, but it is $54 billion that are coming out to the states. And that's, of course, just looking at the size of the market, this is many times more than what is the revenues and turnover in the market for OUD today. So the grants are not insignificant, at least as a starting point, but hopefully, some of the grants will convert into more, you can say, repeating business and just to have to apply for grants. But right now, we think OX124 could be a good complement into these grant applications.

[Operator]

The next question comes from Klas Palin from Erik Penser Bank.

[Klas Palin, analyst]

I have a couple as well. And I would like to start with about the [indiscernible] market. As you mentioned in your presentation and the CAO word about the new legislation that was in place from the beginning of the year to open up the markets to more prescribers. But you have not seen this materialize in the market. And do you see the number of prescribers growing? Or what is happening right now? And what do you see is needed to really get this new legislation going?

[Nikolaj Sørensen, executive]

So we do see the number of prescribers, I believe, and now I should have read my data a little more. But I believe it's increased from about 50,000 to a little more than 60,000. So about 10,000 more prescribers have been added during the start of the year. But we don't really see any volume -- most of them are, if they are prescribing at all, we are seeing that they're prescribing to relatively few patients. And I think this is one of the -- could be one of the challenges with this move is that the prescription base has become a little more fragmented as this would actually allow your normal family doctor, if they have been -– if they have received a certification to prescribe any controlled substance, so that includes, as I said, for sleeping agents and painkillers, they could also prescribe ZUBSOLV, for example. And of course, if they just do that for 1 or 2 patients, that makes it more difficult for Orexo to reach them. But so far, we still see a very high concentration of prescription of buprenorphine/naloxone products as we have seen since launch. And there are no indications that that will change. But what we hope is that the new legislation would enable some of those centers to expand more rapidly because it becomes easier to recruit new physicians. And I think on top of the increased financing, that could give them some incentives to expand that business. But the main hurdle right now, I think is -- one is maybe the knowledge that this is there that no big companies out there driving new prescribers, as you probably recall, Indivior at that time with Benckiser, were really active of engaging new physicians. Orexo with 2% to 3% market share is not at the size where we can drive the market moving forward. So I think that could be one aspect. The other aspect is that there are uncertainties about what is required to obtain that license to prescribe these products. So it's not completely clear what kind of education you need and how do you get that education. So there are some administrative hurdles, but I think it's a good facilitator for long-term growth, but I don't think this will create a hockey stick development and volumes in the short term.

[Klas Palin, analyst]

And then I would like to jump to the DTx and the MATCore. And perhaps if you could describe a little bit where you are in the process in Arizona and when it could be possible to expand this to additional states? And if you think this could be some generating revenues in 2023?

[Nikolaj Sørensen, executive]

So it already does generate a little revenue in Arizona. There have been some issues around Arizona. It's [ ALI ] clinic is focused on telemedicine. And there are some issues around the -- I think it's legislation in Arizona, where you need to meet the patients physically. And as they are not -- they don't have a physical presence, we have to set up a process for that also. It's -- so the price per patient is relatively high in these grants because it involves also a development of a new concept. So it's not a significant amount of patients in Arizona, but we are working actively with ALI to include the patients that is covered by the grant. I believe it's about 25 patients.Then we have applications submitted in several other states in the U.S. and these other applications, some of them are of significant larger size than what we have in Arizona. And I also want to remind those who have been following the digital space that actually Path Therapeutics, a quite sizable share of their revenues came from grants in different states. So there are some relatively large brands to be obtained over time.

[Klas Palin, analyst]

And just more of a discussion about your financial outlook. I mean you have already touched upon this a little bit. But I guess it seems a little bit conservative about the EBITDA guidance and so on. I guess, is there any costs or anything that makes you uncertain why you're seemingly at least a little bit conservative when it comes to guiding that you would reach EBITDA in balance for H2?

[Nikolaj Sørensen, executive]

I think there are a couple of elements. So one is we have the resubmission of OX124. Are there any issues that appear in that process before we submit that we have to redo some of the qualifications and others is could drive some uncertainty. We don't believe that. And we're very optimistic. We actually have -- I believe we have people in Canada right now. We've broken their vacation to go over to run the final tests. We also have some of the legal expenses where, of course, if there is an appeal, we will see how much and how they appeal. If they do that from Sun, that could drive some expenses. And then we have the government investigation or the subpoena process, which could also drive some expenses if things are moving. That one, as I said, has been going quite sporadic. So there have been short periods where there have been activity and then there's been silence for many months. So that creates some uncertainty, of course. But I think it's important for Orexo right now to really stay the course and, you say, probably be a little more conservative in our forecast. And then you could trend some of the expenses and sales up to levels which are more positive. But I think at the moment, we want to stay in the -- in a position where we feel confident that we can meet those guidance.

[Klas Palin, analyst]

And congratulations by the way of reaching the EBITDA balance already in Q2.

[Nikolaj Sørensen, executive]

And we've received one question from the net. And that's what is the last day for appeal by Sun? So the thing is that the appeal process is triggered by when the formal judgment has been published. And so far we have seen the court order, and we have seen the redacted opinion have been published, but actually not the judgment. And the judgment, we expect that to be published probably end of this week. And from that date, it is 30 days that they have. So from the day the judgment has been published, they have 30 days to submit their appeal.

[Operator]

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

[Nikolaj Sørensen, executive]

Thank you so much for joining us here in the middle of the summer, probably a lot of you are on vacation. My sincere apologies for the issues in halfway through the presentation. We lost connection, appeared to be from our side, even though I have full connectivity, it appears. But we had some issues in the middle, and I hope it didn't disturb the presentation too much. I think we managed to connect back quite soon after.So thank you so much for attending this call, and I wish all of you a great summer. Goodbye.