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

Welcome to Orexo Q4 Report 2022. For the first part of the conference call, [Operator Instructions] Now I will hand the conference over to CEO, Nikolaj Sorensen. Please go ahead.

Thank you very much, and welcome to this fourth quarter and year-end presentation from Orexo. So the fourth quarter has been a quite eventful quarter from many aspects, both internally and externally. It's also been a quarter where we, on a quarter-by-quarter basis, have a decent headwind in terms of exchange rate development with the U.S. dollar weakening compared to the Swedish krona. But on an annual basis, the strengthening of the U.S. dollars have had a positive effect. And I will come back to that later. So with me today, I have Fredrik Jarrsten, who will go through the financial results a little later in the presentation, and I will take you through the key achievements for the year and also give some business updates on U.S. pharma, Digital therapies and our headquarter pipeline. So with that, I will start moving into the key achievements. So if we take a perspective on 2022, this is the year-end result. I think this year has made some good progress, in particular within R&D, where we have our new platform, amorphOX has been tested in multiple different both small and large molecules with consistently good results on particular stability data. We have also seen, again, strong clinical data when we test our platform in a new API, that's on OX640. We have started research partnerships, both with leading biopharmaceutical companies. And even before that, we had a partnership or have a partnership with a U.S. pharma company who have a small molecule that we're testing in amorphOX. Then we have ZUBSOLV being launched in multiple different countries in Europe and hopefully something we'll see a good progress with when we come into 2023. But we also have OX124, where we had expected filing in the end of Q4. We were ready, but we needed some final information or approval from FDA, in particular, related to our pediatric plan. And also, we had to update some analysis in our own material and the submission. But right now, the only thing that is waiting is some administrative tasks that needs to be done before we can publish our application to the FDA. So this should be done be ready quite shortly and there are no more risk to the filing. It's more a timing issue. When it comes to U.S. pharma, we have seen a ZUBSOLV, as anticipated, is down compared to last year. But we have seen throughout the year a relatively stable development of ZUBSOLV with not too much movement quarter-by-quarter. We also managed to keep our market access and increase market access in the public segment, now up to nearly 50% of the patients -- we have maintained our quite fantastic market access in commercial with 98% of the patients having access. And that is in a market where we have more than 10 active generics. So compared to many other products in similar market situation, this is a very strong result. In the U.S. pharma, we continue to have a very strong EBIT margin. And after a little low Q3, we are bouncing back in Q4 with an EBIT margin of 54%, which is also the full year result, and we have a good EBIT contribution from our U.S. market. The one thing that has been a disappointment for the year is clearly that the market growth is in the lower of our range, but we had anticipated an accelerated growth in the second half of the year and particular in Q4, which we didn't see, and I will come back to that a little later. In Digital therapies, we have managed to get the deprexis reimbursed on Veteran Affairs under the federal supply schedule. We have managed to have the operational implementation with Trinity Health. We have more than 2,800 patients who received MODIA through our early trial program. We have the first MODIA patients who are now in what we call billing test. That means we have submitted billing to the insurance companies are now waiting to get that confirmed. And we have now -- during the last part of the quarter, we have received or [ to ] health care providers in the U.S. We have been part of 2 grants, one for deprexis and Vorvida, which is in Minnesota with the Wayside Clinic and one in Arizona, where we have included what we call MATCore, which is kind of an umbrella concept, including all of Orexo's different services, pharmaceuticals and MODIA digital therapy. However, in digital therapy is no secret that the commercial progress has not been up to expectations this year. When we look on an annual -- and just apologize maybe if you can hear some background noise, but we clearly have a truck who is working right outside the office window. So my apologies for that. But coming to the 2022 financial results, we have seen our revenues growing with 9% on an annual basis. That is explained by tailwinds from foreign exchange with the Swedish krona weakening compared to dollars. And since most of our sales is in dollars, that has been positive on our net revenues. However, that also has a negative impact on our expenses, and you will expect to see a relative similar effect on EBIT. But we have maintained and actually improved our U.S. pharma EBIT compared to last year. The spend of -- despite most of the -- or all of the expenses in U.S. pharma is dollar-denominated. Our EBITDA, when we take away the legal expenses and expenses for clinical trials is a positive on a full year basis and is in balance in Q4. We have a good and solid cash position, even though we had a negative impact on the cash flow in this quarter. Fredrik will talk a little more about that later. And we have a lot of opportunities right now, in particular, in R&D, where we see good opportunities for partnerships would be revenue generating. And if we decide not to make any further investment in clinical trials and have no new legal processes that we need to finance, we do have profitability in sight for the company. Moving into U.S. Pharma. So something that I'm not sure have been that much noticed in Sweden is that the Data 2000 waiver or system that has been in the U.S., where there have been a cap on how many patients you can treat and who can treat with buprenorphine naloxone was removed by -- on December 28 by decision in the U.S. Congress. And that is then replaced by a new requirement to take an 8-hour education for prescribers of all controlled substance that includes pain medication, ADHD medication, some antiepileptic medications and similar. So this is something that we expect nearly all physicians in the U.S. would have to do because most physicians will prescribe one of these categories of products. And that would mean that subsalt other products in the category would be able to be prescribed by nearly any physician in the U.S. That also means that the concentration of the prescription that we see today on what we call data 2000 waiver physicians is likely to be reduced and we will see a change in the market. What you normally see when you have a much better access to a medication is that we will see a positive impact on volumes as more patients can have access to treatment and particularly in opioid use disorder, we believe that access to reimbursed treatment is very positive. We know that about half of all of the clinics today who are data 2000 waivered do not accept insurance, but nearly all GPs in the U.S. except insurance. And as they can now start to prescribe, we think this is removing a barrier for treatment for a lot of patients. When we look at the impact for ZUBSOLV for Orexo, we see, of course, that the market is likely to expand as we improve the access to treatment I just talked about. And we expect the market to evolve into a structure, which is similar to what you see in other mental health diseases, where you have a primary care taking care of the more mild and moderate cases, and you have a specialist care who is taking care of the more severe cases. And when the severe cases are becoming mild or moderate, they are moved back to primary care. However, opioid use disorder is a tricky disease to treat and something where the patients are requiring a special treatment, in particular in the first sensitive weeks of induction, it's also an area where you need access to counseling in a way that is not normal, I think for the most of the primary cab physicians to provide. This is something where we see Orexo with our field force with the information knowledge they have about the disease space, but all the material we have to support the physicians with our MODIA platform is we can fill that gap in the market and be a big support for these new physicians. That also increases the synergies between our Orexo digital therapies, our pipeline with other disease spaces significantly. However, it will mean that the market is likely to be more fragmented. And that, of course, put a new challenge to our field force in the U.S. So how do you manage that where we before had a pretty distinct target group data 2000 waiver physicians, we now have to look at a more fragmented market. And here, we need to have a new approach, a new thinking about how can we address this market in an effective way. We believe one way to do this is to combine our resources and the knowledge that we have within the company, the tools we have in the company under one umbrella platform or concept that we have named MATCore. And this is why we see we can work with regional health care, with health care networks to make -- to support new physicians in having more effective treatment of opioid juice disorder and to reach new target groups. So moving into MATCore. So what is this? So MATCore is actually something we are branded and we have worked on for the last year, where we have been in dialogue with the Attorney Generals with the states following the expected payout of the settlement money coming out of the opioid litigations. And where we're seeing what do you need to improve health care for opioid juice disorder. And we have seen that the say, collective knowledge and tools we have within the company, if we put that into one concept, we're actually able to provide a platform which is much more comprehensive where you can support both physicians and patients with counseling, with access to medication, with adherence tools, with knowledge, patient educations and so forth. And we have our database and system that we have behind all of our detailed therapies, which is HIPAA compliant. That means that we are delivering on the highest requirements in the U.S. for patient data and where we can collect and analyze these -- the input from -- we get from the patient treatment and feed it back into the states and the health care providers and the payers. So this is a concept where we will provide that as an offering to work with local health care providers initially to lower the risk and to improve our effectiveness when we develop. We have targeted grants in different states, and we have the first grant awarded in Arizona to Alay Psychiatry, which is a specialist addiction center in Arizona, who have received a grant to work with Orexo to make MATCore available for specific groups within Arizona. So this is a very good opportunity to us to work with health care have a financed rollout and implementation of MATCore from the start. And with success, we will, of course, look to expand this. But initially, the target is to make grant applications in different states and through the grants, getting a financed implementation and rollout, which reduces the risk and we believe is a faster way to market than going through more traditional product development. So into ZUBSOLV, we have seen in Q4 a mild decline versus Q3. And I must admit the development in Q4 is a little of a surprise to us because Q4 is usually the strongest quarter of the year, both for the market and for ZUBSOLV. We have actually not seen any years in the 8 prior years when we've been in the market where Q4 has not been the strongest quarter of the year. And that also means, both in terms of volume prescriptions, patients are getting more prescriptions before Christmas or before New Year because they come into a new co-pay period. We are seeing pharmacies and wholesalers traditionally are increasing their stocking in the before Christmas. But we have not really seen that this year. We didn't see that in the market, and we didn't see that on ZUBSOLV and that was a surprise to us when we look at the volume development. One thing that is positive now when we start the new year is that we haven't seen the normal dip that we have seen. We just have a few weeks of data in January. But in the first weeks of data, we haven't seen the dip that we normally see in January from December. So that indicates we have a new seasonality, you can say, in the market, at least for '22 and '23. What we have also done is, of course, when we go through all of the published reimbursement formularies in the U.S., and we have -- can confirm that we have a 98% coverage in commercial, 48% in public. In commercial, we have seen some plan where ZUBSOLV has been removed from the preferred plan, but we have also seen that we've been added to other plans, which, all in all, before Christmas, it was 99% and now we have 98% access, which is very -- still a very strong result. The market growth, as you can see here, and if you look historically, you will see every dip on the curve that we have on market development is in Q1. But here, we actually saw that dip or flattening of the development in Q4. So where we have a 3% increase in sales compared to last year. But that actually means compared to Q3, it is stable or it's actually slightly negative. Looking ahead, of course, with the new legislation with the funding that is coming in, we believe that there are good opportunities for this market to accelerate. We know that today, we have less than 2 million patients in some kind of treatment on an annual basis, but we have more than 10 million people in the U.S. who is using opioids in some form. So there's great growth opportunities and need for growth in treatment to reach more people in the U.S. than what we have today. Digital Therapies. So we have made some progress, but it's clear it's not met our expectations. What is moving well is MODIA where we are seeing that we have more than 1,000 -- close to 1,000 patients who received MODIA in Q4, as prescribed by the physician. Of these physicians, we now have in select states. We have 40 patients who are in what we call billing test, that means that we -- the clinics have sent in a request to get financed the treatment, which is including MODIA, -- when that reimbursement is confirmed, we will invoice the clinic, and that will be revenue for Orexo, which we expect will happen in Q1. And as we have these selected clinics in the states, we can roll out to other clinics in the same state and say now we have reimbursement confirmed by your payers. We also made some good progress with having a first grant from the Wayside Recovery Center, who is going to treat 60 patients with either deprexis or vorvida. And we have seen the first patients have received deprexis now in the new year, and this is -- Orexo will sell deprexis to Wayside recovery center, so that will be recognized revenue. We have the first patients in Trinity Health, but it's very clear that Trinity Health is so far not meeting the expectations. And here, it's in particular, within primary care, where we have seen that the front-end physicians who need to enroll the patients have not really started to use the deprexis or vorvida in any meaningful scale. And here, we need to work much more with the pull through and to get this reminding them about the advantages supporting them and getting the first patients in, which is what we're used to do in pharma, but it's not really been working for the detailed therapies in the start with Trinity Health. So there's more to do with Trinity Health in North Dakota. We have Veteran Affairs, where we're making some very good progress. We have some important stakeholders within Veteran Affairs working with us to roll out a program, including deprexis. We have some other pathways that we're testing, in particular, our new Chief Medical Officer, has worked with Veteran Affairs and have some good network as a psychiatrist into Veteran Affairs that we believe we can leverage to find ways to make the practice available for more patients. But it is taking time Veteran Affairs is probably one of the most bureaucratic institutions in the U.S., and that's something that we have seen during this autumn that the distribution and administration to make an effective availability of deprexis will take some time. But we are making good progress, and we have some good buy-in from key stakeholders in Veteran Affairs. When we look forward and look at where we are, we are looking at a market where we have data 2000 removed, as I just talked about in opioid use disorder. That actually means that we have now expanded synergies not only for MODIA and ZUBSOLV, but we also see that we will have new physician groups coming in and being able to prescribe ZUBSOLV. That is increasing the synergies with other products in the pipeline such as Deprexis and vorvida. We have developed MATCore, which is an integrated offering where we both have mitigation, counseling and other services, which again is targeting the same group of physicians without our field force in the U.S. and sales resources. And then we have a situation where detailed therapies has not delivered on the expectations for the last year. And that has led us to take a decision where we will integrate our digital therapies into our U.S. Pharma business, and that will happen from February 1. That also means that some of the senior management positions that we have in the organization and some marketing positions are made redundant, and some of these tasks will be taken over by our U.S. pharma organization. The resources we will keep dedicated DTX resources will be integrated into the functional structure of our U.S. pharma. We will add more sales-focused resources. So from marketing into clearly field and sales focused resources will be a change in the constitution of the organization for supporting digital therapies. We will, however, continue with separate segment reporting for the 2 business areas as we have started to do that. We will continue to do that. However, the resources that's under digital therapies will increasingly be shared resources with our U.S. pharma business. So this is a change to increase both efficiency and focus on sales and detailed therapies. So to our headquarter pipeline. As said, OX124, we are making good progress, but we didn't receive the response from FDA, which was due in the late summer. We received that in mid-January, and that then needs to be implemented. And together with some additional analysis that then was required by Orexo that has delayed the process with filing OX124. However, we are at a point right now that the only thing that is needed is some administrative work to make -- to meet the requirements for the filing administratively from FDA. So this is a timing issue, and we're not waiting for any more data and input. I would also say that when we have filed the ordinary approval time line is 10 months, but some of the recent approvals in the category has been up to 13 months on. So we'll see how fast this will take when we get our PDUFA date from FDA, approximately 60 days after the filing. OX640, we continue with the work internally to prepare large-scale manufacturing. We continue to review the development and partnering strategy. That means that we're talking to potential partners to see what structures could be relevant. And we basically -- I think there was maybe a misunderstanding after Q3 that we stopped the OX640, but we continue the development right now, but our ambition is to find a partner for some geographies in the remaining development steps. For amorphOX, we have our first partnering in biomolecules, which has been a key part of the strategy is that we don't really work with biomolecules yet at Orexo, but to find leading companies in that space who can make their proprietary API available and work with us to test whether amorphOX create value for their API is a very important step. And I'm very pleased with the 2 partners that we have contracted in this space. And just to give you an overview of what we work with. So one of the strategies we had with amorphOX is to test a diverse set of both small and large molecules. And we have seen consistently, as you can see in this picture, a positive development. And this means not that Orexo is looking to develop all of these molecules. But these are picked because of unique properties for each of the molecules that we think is worth testing in amorphOX to strengthen the patent situation. But of course, also this offers an opportunity for business development with companies who could be interesting in developing products based on these APIs. The latest one we have done is on the spike protein. And I will again underline that we are not looking to create a COVID-19 vaccine at Orexo, but we found that the spike protein was a perfect model protein to test whether amorphOX could add good stability and whether we could create a powder, which could be used in a nasal spray, and we have confirmed that with our test in the spike protein. So with amorphOX, we are looking at a situation where we have multiple different business development opportunities for several of these APIs that you see on the screen, but also for companies coming in with their own API, and that's the situation with the 2 biopharmaceutical companies who are right now starting a feasibility study together with Orexo. With that, I will open up for Fredrik to take us through the financial update, Fredrik?

Thanks, Nikolaj. So if we continue to Page 20. Let's look at our revenue, and we start by looking on the top part of this page, you can see that our total revenue in Q4, SEK 156 million, that's 8.4% higher than in Q4 last year. And of that revenue, obviously, ZUBSOLV within U.S. Pharma is the main contributor with SEK 143 million for the quarter. That's up 7% from Q4 2021. And the main explanation for that growth is the strong appreciation of the U.S. dollar. Net revenue was also in the quarter negatively affected by a onetime adjustment in accruals within gross to net of SEK 4 million, which was due to higher returns in 2022 than expected. Now if you look at ZUBSOLV specifically and Q4 compared to Q3 this year, this gross to net adjustment I just spoke about, that is also one of the explanations why net revenue decreased by 5%, as you can see from the waterfall graph on the bottom part of the page. We are pleased with the continued stable sub-sold demand, although as Nikolaj told you, there's a mild decline in demand, as you can see in the first 3 bars in the graph. Now this was more than offset, though, by wholesaler inventory stocking in Q4, close taking closer to the year-end, which is also anything that comes back every year for us. That had a positive impact of SEK 7 million. Now the FX effect was also positive quarter-over-quarter with SEK 2 million when you compare with average FX rates during the quarters. In conclusion on this page, you can also see in the graph that in local currency, the ZUBSOLV net revenue declined by 6.5% between the quarters. Moving to the next page. We look at our P&L. I just mentioned the growth in total net revenues for the quarter. For the full year, that growth is 10.5% to SEK 624 million. The majority of that growth is again the effect of the strong U.S. dollar. Increase in COGS is to a large extent also a reflection of the strong U.S. dollar. And when you look at our operating expenses, we are, as you know, focused on driving future opportunities, which in this quarter included higher R&D costs in relation to the MODIA study as well as COGS progressing OX124 filing. We had increased expenses also defending our business in relation to the IP litigation. Now that was partly offset by significantly lower selling expenses in DTX. OpEx was also negatively affected by the stronger U.S. dollar and in conclusion, increased year-over-year from SEK 188 million to SEK 201 million. For the full year in OpEx, we landed within the anticipated range in our financial outlook 2022 at SEK 76 million. Our U.S. pharma business shows again a good quarter with SEK 77 million in EBIT. That's a margin of 54%, which is the same as in Q4 2021, but it is up from 47%, which we reported in Q3. EBITDA, minus SEK 53 million, that's down from SEK 49 million. And this is obviously also affected from the stronger U.S. dollar, and that effect was SEK 6.8 million. Then in financial items, we have a negative unrealized FX impact of SEK 18 million on our cash and cash equivalents held in U.S. dollars. Also, higher cost of corporate bonds of SEK 7.8 million partly offset though by earned interest on cash and short-term investments of in total SEK 2.2 million. Right. On the next page, we just wanted to highlight the point we want to make of Orexo having a positive EBITDA if we separate what we define as distinct external nonrepeating costs. In conclusion, for the full year, these nonrepeating costs amounted to in total SEK 173 million. And our EBITDA, as you can see from this graph, would, in that case, be positive SEK 58 million. If you do this exercise for Q4, the EBITDA would come out as breakeven. But as we said, this quarter was significantly affected by the increased R&D expenses and by this negative onetime adjustment of gross to net accruals. You can see the external nonrepeating costs listed on the right-hand side of the page, that is then related to the clinical trials of MODIA, OX640, OX124 as well as a cost for the legal processes. You can see that these trials of OX640 Phase I and OX124 human factor study was finished in Q4. And for 2023, we expect the MODIA Phase III trial completed by the end of Q2, and the Sun litigation trial will happen in Q1 2023. So that means that after the first half of this year, we will no longer have any of these costs. And this is the main reason why we emphasize this key metric that is confirming our route to returning to profitability. And then on the next page, moving to this page, we can see cash flow. We can see that liquid funds, which is the cash and cash equivalents as well as the short-term investments, that amounted to in total SEK 352 million end of Q4. Now that is a decrease by SEK 92 million from the end of Q3. So what is that? Cash flow from operating activities was negative for the quarter with SEK 49 million, which was obviously impacted primarily by the negative operating earnings. We have gross investments in fixed assets for the development organization of SEK 12 million. We also had amortization of leasing debt of SEK 6 million, and we had a realized FX effect of SEK 2 million on cash assets in USD bank accounts. And the remaining difference explaining the SEK 92 million being a negative FX effect also on the short-term investments, which end of Q4 amounted to SEK 220 million. And the pure cash and cash equivalents was then SEK 132 million. That gives a total of SEK 352 million. And with that, I want to hand back to Nikolaj, will pass the outlook.

Thank you, Fredrik. So the financial outlook, maybe I should just comment on 2022. So out of the financial outlook we gave for 2022, we were missing on one of the points. Maybe the most important note. We were correct in the market development with the growth rates. We were in the lower range of the range we provided, I believe, of 5% to 8%. We had expected that the growth would pick up in the second half of the year, which it didn't. And as I said before, we were surprised to see the normal seasonality with Q4 being the strongest quarter, not repeating itself for 2022. And we can speculate about the reasons for that. And I think there could be some related to new structures around how you can store control substance pharmacies. But the one thing we had not anticipated for sure was the adjustment for returns. We're normally very conservative in how we are reserving or accrue for returns in our gross to net calculations and that has led consistently to some positive adjustments coming in quarters, in particular, when we get to the end of the year. We are normally reviewing these accruals and then decide if we should do something different or reverse some of the accruals, which would have had a positive effect. This year, we had a negative effect, and that's the first time since ZUBSOLV was launched that we had to make a negative adjustment into the gross to net calculations and this time, a quite sizable one. It is due to a third-party logistics provider who is managing the returns for us had not reported the returns that they had received during 2022 before mid of December. And that came as a surprise to me and to the organization, which had unfortunately instead of a positive expected positive result on dose adjustment and accruals, we had to do a negative adjustment on accruals, which had a negative impact on the target we had with the second half of 2022 to have higher sales of ZUBSOLV compared to the first half, together with lack of growth in the second half of the year. On the OpEx, as Fredrik said, we were correct also for the year. And just looking into the target for this year, we have now lowered our expectations a little to market growth to 4% to 7% compared to last year. However, we have not taken into account the changes in legislation that are effective right now, but there's still uncertainty about what it takes for other new physicians to prescribe buprenorphine. And before we know the time line of the implementation, we have based our trajectory on the growth rate that we're seeing at the moment, where we're seeing a slowing down in the end of 2022 and actually also year-over-year in the beginning of 2023. However, we have not seen the drop in the beginning of the year that we used to see. On the group revenues, we expect the ZUBSOLV we will have a total increase of revenues, and we expect that will come from our partnering with [indiscernible] with ZUBSOLV in Europe. We have business development opportunities in -- from our R&D pipeline, and that will support us. And we also expect that ZUBSOLV revenues will remain stable at least throughout 2022. And that would be -- put them in line with our -- or 2023, and that will put us in line with the 2022 numbers. On OpEx, we expect to increase the level now in the first half of the year, and that's in particular now in Q1, where we have our court case with Sun Pharmaceutics up next week, which is the most expensive part. We also -- for OX124, we have just paid the filing fee to FDA. And that comes in, in Q1. Also, that's about SEK 17 million that we have to pay to file OX124 -- so we expect the OpEx in the first half to be slightly higher, not a lot, but slightly higher than the second half of last year. But in the second half of the year, we actually expect to see a decline both in Q3 and then again in Q4. We expect that our EBITDA will balance be in balance when we look over the 2 quarters, Q3 and Q4, and that means around 0 in group EBITDA. So this is our outlook for the next year. Moving into the legal situation. see here where we are. On the ZUBSOLV patent dispute with some pharmaceuticals, we are getting very close to the District Court. It's starting on Monday in Trenton, New Jersey. I will say that yesterday evening, we received the outcome of the Markman hearing, and that's where the 2 parties that's why the judge and the court decide on the claim construction and on disputes between the 2 party and how to interpret certain parts of the patterns. And I'm quite pleased to say that the court went fully on Orexo side and we're deciding in favor of Orexo on the claim that was in dispute in the Markman hearing. That's just one step, but of course, an important step when we go into the court during next week. On the subpoena, we have not seen any material activities during Q4 and not seeing anything now year-to-date in 2023 either. So future value drivers, just a short overview. We do, as Fredrik was saying, we do see that we have very high nonrecurring expenses right now. This quarter was also hit negatively by exchange rates, which otherwise have been positively affecting Orexo throughout the year, but Q4 over Q3 has been -- was impacted negatively. But overall, when we take away these recurring expenses, we do have corporate profitability in sight. We have an R&D pipeline where we expect to see some revenue-generating partnerships during 2023. That could be both for OX640 but also for some of the other amorphOX opportunities. We do expect to see some DTX revenues coming not both for vorvida and deprexis, at least from the grant process, we're expecting to see the MODIA billing test turning positive, which would enable us to revenue -- recognize the revenues from these first 40 patients that have been included in a billing test. And then we expect to see ZUBSOLV sales being stabilized, and we do see some quite exciting opportunities to grow, both from the MATCore that we're providing out of the settlement funds of $54 billion, which are coming into the states for improving treatment of opioid dependence. It is the new legislation that opened up access to more physicians. So there are a lot of stuff that happens in the buprenorphine naloxone market in 2023, which could be a lot of opportunities for Orexo, but of course, also some challenges associated with that. And with that, I and done with the presentation, and we'll open up for questions.

[Operator Instructions].

I have a couple of questions, if I may. And a little bit about the Trinity Health collaboration, the sort of a hurdle for you right now. Is that coming from few physicians? Or is it patients that are reluctant to enter treatment with the DTX therapy?

So if we start with that question on Trinity Health, the main challenge right now is that the primary care physicians want additional information and education about how to introduce patients to the products. They don't feel comfortable in how the product is going to be used by the patients and the role that they have to take. So we have started a series of educational activities with the physicians. It is a little of a challenge in North Dakota. We don't have any sales resources in place in North Dakota. So we need to find ways to reach out to Trinity Health. But it is what we in pharma would additional pull-through activities to make physicians comfortable of using a new product, and that's the same challenge you would have with a new pharmaceutical that they are not educated and used to. So it's not what we hear from them. It's not about the patients. It's more the physicians who, I think, are turning to old habits and how you treat it rather than testing something new.