Camurus AB

STO:CAMX

Earnings Call Transcript 2022-Q4

[Operator]

Welcome to Camurus Q4 Report 2022. [Operator Instructions] Now I will hand the conference over to CEO, Fredrik Tiberg.

[Fredrik Tiberg, executive]

Thank you so much, and good day, everyone. Welcome to our last earnings call for 2022. It's a great pleasure today to be able to present strong fourth quarter and full year results, along with significant progress of our business. I will assume you have read our forward-looking statements. And with this amount of caution, let's move into today's agenda.

We will start with a summary of our achievements in 2022 and the fourth quarter. Then I go over to the financial results and the 2023 outlook, followed by commercial and R&D pipeline developments. We'll then finish off with a summary of the quarter, upcoming milestones in 2023 before going to Q&A. So as in previous calls with me today is our Chief Financial Officer, Jon Garay; and Chief Commercial Officer, Richard Jameson.

So as I already alluded to, 2029 (sic) [ 2022 ] was a very successful year for Camurus where we, for the first time and ahead of plan, entered profitability, driven by growing revenues and gross margin improvements. Our total net revenue increased by 59% and SEK 956 million and the operating results increased from a minus of SEK 112 million to a positive result of SEK 72 million.

This, while also investing around SEK 0.5 billion in the R&D pipeline and future growth for the company. We continued strengthening our leadership in long-acting opioid dependence treatment across Europe, Australia and EMEA, received three new regulatory approvals and five pricing end market access approvals during the year. Buvidal is now available in 20 countries and the geographic expansion continues.

On the R&D pipeline side, 4 Phase III trials progressed during the year, and we also started a new clinical program in polycystic liver disease. I'll go in more about this in a few slides, but let's first zoom in on the fourth quarter highlights. So in the quarter, we delivered double-digit revenue growth versus previous quarter.

It was our fourth consecutive quarter with positive operating results and the third with profits. We received the first digital orders from Egypt and Saudi Arabia at Q3 approvals. And on the other side of the Atlantic, our U.S. licensee, Braeburn, resubmitted the NDA for Brixadi, which shortly thereafter was accepted for review by the FDA, with the PDUFA date coming up later here in May.

So moving in then to R&D. We completed recruitment in our pivotal Phase III trial of CAM2029 in acro and passed the milestone of 100 patients randomized in the SORENTO Phase III trials in gastroenteropancreatic neuroendocrine tumors. So as presented in our Capital Markets Day in September, we also worked diligently to strengthen our sustainability framework. Here, we worked with implementing an updated sustainability strategy covering ESG aspects throughout our business processes.

We strengthened our management with a new experienced Head of Corporate Compliance, Jonas Duborn and Director of Sustainability, Iris Rehnström, as welcome new members of Camurus' team. Examples of more specific activities in the quarter were medical education efforts for health care professionals in Ukraine to support treatment with Buvidal, which was donated at the request of the Ministry of Health and the first patients are now starting treatment or have started treatment.

We also supported several disease awareness campaigns, worked with ESG monitoring and reporting in the supply chain and introduced the whistleblowing digital platform. Going forward, we will continue to drive new initiatives in our sustainability focus areas, as you can see here on the right-hand side. So with this brief intro, I will hand over to John to give an update on the financial performance and outlook for 2023.

[Jon U. Alonso, executive]

Thanks a lot, Fredrik, and good afternoon, everyone. We would like to share with you now the main highlights of our financial performance this quarter. If we move to next slide, we can see the main components of our operating results once revenue has already been covered by Fredrik.

Gross margin improved 496 basis points in the quarter, driven by, firstly, scrap reduction in our operations, delivering 260 basis points; and secondly, better country price/mix and efficiencies on higher volumes delivering the rest. In total, gross margin delivered SEK 240 million in the quarter, where full year gross margin reached 89.2%.

Total OpEx reached SEK 223 million, a 28% increase versus same period prior year, driven by following three factors: Marketing and distribution investments to support market penetration in own territories and expansion of Buvidal into new markets; administrative expenses aligned with corporate evolution to substantiate company development; and fairly R&D progress in the three indications of our CAM2029 program, where acromegaly patient recruitment was completed during early Q4 '22.

On a full year basis, our R&D investment has been SEK 474 million aligned with SEK 0.5 billion range indicated earlier this year. Company operating results became positive by SEK 19 million in the quarter and SEK 72 million full year. This was mainly driven by sales growth and gross margin improvement. Profitability may fluke the way between quarters as we continue investment in our pipeline to bring product candidates to market as soon as possible.

If we now move to next slide, our cash position at quarter end was SEK 566 million, delivering a 37% growth versus same period prior year. Camurus generated SEK 46 million cash in the quarter, mainly driven by company operations generating SEK 32 million. Improvement in working capital generating SEK 14 million and warrant program exercised by employees generating SEK 4 million.

At end of quarter and year, Camurus has no debt. Our guiding principles for capital allocation continue being reinvesting in our business to accelerate Buvidal market penetration and geographical expansion as well as bringing CAM2029 to market as planned and secondly, support our company strategy in the area of inorganic growth opportunities enhancing our company value.

If we now move to 2023 financial guidance, we expect company revenues in the range of SEK 1,530 million to SEK 1,650 million including anticipated milestone payment following Brixadi NDA approval in the United States by a value of $35 million and profit before taxes in the range of SEK 425 million to SEK 525 million. Company guidance is taking following considerations into account. From a total revenue point of view, potential downward pressures due to austerity measures implemented by some governments are a risk and we are planning to address certain market access holders.

From a strategic investment point of view, where Camurus is ahead of profitability when compared to our long-range plan 2027, company will continue to invest during 2023 somewhat more than during 2022 to support our strategic vision in following areas. Incremental R&D investment to bring CAM2029 to market the sooner the better in the range of SEK 0.1 billion versus prior year; a new proprietary development relating to FluidCrystal technology, U.S. organization development, systems aggregate and structural development to support company growth in the range of SEK 0.1 billion versus prior year.

All in all, Camurus closes 2022 with a solid financial position, interesting growth opportunities and is on track to continue its growth in line with the long-range plan vision shared at September Capital Markets Day. Having said that, I would like to pass the word to Richard. Thank you, everyone, for your attention.

[Richard Jameson, executive]

Thank you, Jon. So move up to a commercial development update. We ended the year with record Buvidal sales in the quarter of SEK 267 million, which corresponds to an increase of 57% year-over-year and 11% versus the previous quarter. Quarterly growth returned to double-digit growth after slowing in Q3 due to the holiday period.

In Asia, Oceania, we saw growth of 22% and Europe 4%. However, this was mainly driven by stock levels at wholesale at year-end. And it's important to note that the underlying end market Buvidal growth in Europe was 16% versus the previous quarter. Growth was seen across markets with large contributions in revenue from our established markets notably growth in the U.K. and specifically England accelerated as the anticipated new funding to improve the treatment system started to become available at clinic level.

Also, the newer markets saw good growth, particularly Belgium, after we extended the reimbursement conditions and Spain, as we have addressed the majority of the access hurdles at a regional level. And our market expansion also continued. And as Fredrik said earlier, Buvidal is now available in 20 countries across Europe, Australia and MENA. And in the quarter, we finalized the first two orders for two major MENA markets in Egypt and Saudi Arabia, where Buvidal is the first approved maintenance treatment for opioid dependence.

So we finished the year with more than 36,000 patients currently being treated with Buvidal, and we continue to receive very positive feedback from all our markets and the impact Buvidal is making to improving patient outcomes. And looking ahead, we expect several new markets to open in 2023 to further expand with 5 market authorization applications under review and 6 PMA submissions. We also updated yesterday on the withdrawal of a variation application to extend our current label -- opioid dependence label to include chronic pain after the CHMP request for additional data and internal analysis.

The withdrawal, as we said, is not expected to affect Camurus' financial results in 2023 or to a significant extent, impact the company's long-range financial plan. Camurus is evaluating further clinical development of CAM2038 in the treatment of chronic pain, taking into consideration the positive Phase III results and the fact that this patient population of the variation that we apply for already has access to Buvidal for the treatment of their opioid dependence.

Finally, and importantly, we look forward to the approval decision for Brixadi in the U.S. later in the year. As we communicated previously, Braeburn has an FDA acceptance of the Brixadi resubmission and a PDUFA date of the 23rd of May, with potential launch soon thereafter. The opportunity in the U.S. is, of course, substantial with around 1.4 million patients currently treated with buprenorphine. And whilst long-acting injectable products are growing fast with a market size in excess of $800 million, they still have low penetration with less than 5% of patients on a long-acting treatment.

Additionally, the market environment is improving as measures are taken to further address the opioid crisis. There's been recent increased funding in state grants alongside an important change in legislation. This led firstly to the elimination of data waiver for the prescribing of buprenorphine and the removal of the restriction on the number of patients that physicians can treat with OUD. These changes will increase the availability of buprenorphine for treatment and remove a key barrier for prescribing a potentially life-saving medication.

Brixadi and Buvidal in Europe is clearly differentiated and well positioned in the long-acting injectable segment with some clear advantages over other formulations, including initiation of treatment, individualized dosing, both weekly and monthly formulations and multiple injection sites. And you can see this outlined in the table on the right. So we look forward to Brixadi becoming available to U.S. patients. And on that, I will hand back to Fredrik for the R&D pipeline update.

[Fredrik Tiberg, executive]

Thank you, Richard. I will focus this update on the Phase III program for CAM2029, which, as you know, is our subcutaneous Octreotide depot under development for treatment of 3 rare disease indications: Acromegaly, gastroenteropancreatic neuroendocrine tumors is the largest indication here referred to as GEP-NET, and then polycystic liver disease, PLD.

The goal with this development is to come up with a best-in-class therapy with the potential for enhanced efficacy as well as improved patient convenience and in the case of PLD, potentially the first approved medical treatment. We have a comprehensive clinical program ongoing for CAM2029, which we have shown previously, including two ongoing Phase III studies in acromegaly, a Phase III study in GEP-NET and the Phase IIb study in PLD, which was started this summer, all in different stages of completion.

We made very good progress across programs in the fourth quarter in acromegaly. Recruitment was completed in the pivotal Phase III ACROINNOVA trial, and our enrollment goal was reached also in the Phase III long-term safety trial. This was followed by requests by patients and investigators. This study was actually extended to allow for an additional 12-month treatment period in parallel with our planned regulatory submissions.

In GEP-NET, we reached a milestone of more than 100 out of 302 patients enrolled in the SORENTO trial, which is the largest randomized controlled study of somatostatin analogue ever conducted in this important disease area. Our goal here is to demonstrate superiority and progression-free survival. And the aim for 2023 is to complete recruitment of the remaining 200 patients in the study.

In PLD, recruitment progressed in the POSITANO trial and the new clinical sites were opened and activated in both the U.S. and Europe. So we have a very exciting year ahead with top line Phase III results in acromegaly at the first starting point by the end of June 2023 followed by the first readout of the long-term safety trial and in the second half of the year and then submission of a first regulatory approval around the end of the year.

So these are all acromegaly points, and we'll come back to the other programs later on. So in parallel with the clinical work, we have been ramping up prelaunch preparations in the company as we focus on the acromegaly indication. Commercial manufacturing is now established and validated for both the pen and prefilled syringe product presentations and stability data -- formal stability studies are ongoing for the regulatory submissions.

We're also starting our preparations for commercialization of 2029, increasing our medical affairs activities and preparing new publications and participating in key scientific meetings and congresses. The medical team is being expanded with key expertise and leadership, and we are starting to build our own commercial infrastructure in the U.S. in a stepwise process.

So CAM2029, in our view, represents a very attractive opportunity with high market potential, particularly in the U.S. which is, of course, is not unique to this indication. We also see favorable market dynamics with a concentrated target audience, that means can be addressed with a relatively small, focused sales force and a differentiated product profile. In addition, we see the potential to easily switch patients from current first-line injectable treatments to CAM2029 if approved.

With this very brief introduction, I will leave the pipeline update for today and go over to some Q4 takeaways. So in conclusion, Camurus finished 2022 with a solid fourth quarter. We have market leaders in long-acting opioid dependence treatment with Buvidal across our markets with strong growth and penetration and over 4,000 new patients being treated with Buvidal at the end of the quarter.

Buvidal market expansion continues in the MENA and the U.S. approval decision for Brixadi is expected in May. In addition to this, we have 3 Phase III studies progressing in acromegaly and GEP-NET, with the first result coming by end of June. On the corporate side, we continue to develop our organization. We have fine tuned our operating model and -- as well as our sustainability framework, and reached to profitability for the third consecutive quarter and the full year. So based on these significant achievements, we have established a solid foundation for executing on our ambitious 2023 plans. And I have listed the key milestones on the next slide.

So as you can see, we're really looking forward to an eventful 2023, including new Buvidal regulatory and PMA approvals and the long anticipated approval and potential launch of Brixadi in the U.S. In the R&D pipeline, we have already covered the Phase III milestones. And we're also finalizing the preparations for our regulatory submissions, which are expected around the end of 2023, early '24.

In our partnerships, an anticipated highlight is the top line results in Rhythm's Phase III study of our weekly setmelanotide formulation for treatment of genetic obesity diseases. And on the corporate side, we are, of course, as a highlight, starting to build a commercial infrastructure for CAM2029 in the U.S. where we see great market potential. So with this positive outlook, let's move over to Q&A. Operator, can you please take over?

[Operator]

[Operator Instructions] The next question comes from Viktor Sundberg from Nordea.

[Viktor Sundberg, analyst]

So I noticed on the top line that guidance is SEK 1 billion wide. What are some of the pushes and pulls here for you ending up in the upper versus lower range in your guidance. I mean, can you give any more color on the assumptions there?

[Fredrik Tiberg, executive]

Yes. Of course, Viktor, I'll leave it over to Jon to respond to that.

[Jon U. Alonso, executive]

Yes, while our volume growth is strong year-on-year, as we have mentioned during the presentation, our revenue guidance takes into consideration austerity measures that some European Union countries -- European countries and Australia can be implemented during 2022, driven by macroeconomic conditions. In this range, we can say Germany has already implemented a 5% price reduction that we have taken into account. For example, Australia is considering a potential austerity measure at the moment and other countries are going into that direction. This is the main factor.

[Viktor Sundberg, analyst]

Okay. And also, you do include the $35 million milestone potentially from Braeburn. Is that stemming from that you communicated that Braeburn has had an inspection from the FDA already before they've resubmitted the application? Or why do you feel so confident? I mean to include that in your guidance for next -- for this year, sorry.

[Fredrik Tiberg, executive]

So I mean I can take that, Viktor. I think that based on the process that has taken place, and that includes the fact that the manufacturer was inspected or we learned that, that had been taking place prior to the submission. We feel increasingly confident that we should be -- it's likely to have an approval at this time. Of course, there is never any guarantees, so that's the reason we have included it in the guidance.

[Viktor Sundberg, analyst]

And just a final question. In the U.K., I think you showed an ambition to reach a bit over 40,000 patients if the penetration of this market would be similar to Australia and Nordics. So I just wanted to understand a bit more how fast do you think this could be achieved that you get to a similar penetration level of the market? Anything fundamentally different between Australia and the Nordics compared to the U.K.? And how you think that the ramp-up will happen now that, I guess, most patients have reimbursement for Buvidal in the U.K.?

[Richard Jameson, executive]

Yes. I'll take this question of Viktor, there's a couple of indications for U.K., while we think it should accelerate now. Firstly, the money, as I said, are coming into the clinics now, so the government's investment is making it through to where the patients are. I think the other direction is that we've seen good growth in Wales and Scotland, which weren't affected like Kingdom [indiscernible] funding issue. So if we reflect on that, then we should see that acceleration happen relatively quickly in the coming, I'd suggest, 2 years or so, hopefully.

[Fredrik Tiberg, executive]

In absence of -- I don't know if it's AI system works here, but in absence of -- I have a couple of questions here from the audience. And one of these questions was, it would be helpful if we could elaborate on withdrawal of the CAM2038 application in chronic pain. You see a question queue here?

[Jon U. Alonso, executive]

Yes, we can see that [indiscernible].

[Operator]

The next question comes from Erik Hultgård from Carnegie.

[Erik Hultgård, analyst]

Hopefully you can hear me. I have a couple of questions, if I may. First, I think it was actually the question that Fredrik, you mentioned on the web, if you could provide some more information on the path forward? Or at what time point do you expect to communicate more about the path forward? And any additional studies that we need to come back to resubmit chronic pain in Europe? That's my first question.

Then, secondly, on the R&D costs, if you could split down a bit on where you're spending money. Hopefully, if you could provide some granularity on sort of how much is invested in CAM2029 versus the other projects that could be really helpful.

And then finally, on the 1.4 million patients, the number you referred to in your presentation on buprenorphine in the U.S. That seems a bit low compared to a similar number, a competitor to you provided a couple of months back at the Capital Markets Day. So I was wondering what the source of that number is and whether it's patients currently on treatment or patients that have been on therapy over the past 12 months?

[Fredrik Tiberg, executive]

I will try to answer the question. I mean, going first, starting out with the chronic pain applications. So I mean, the origin of this was that we saw an opportunity to improve access to pain physicians, and you get recognition for the treatment effect on chronic pain in this population with the extended label, and we presented this strategy and aligned it with representatives of EMEA prior to submission. And this was also based, of course, on the Phase III data that we had.

So based on the CHMP feedback we had recently, we -- and some internal discussions around that, we decided to withdraw the application because one of the considerations there was that patients in this population already have access for Buvidal for treatment of opioid dependence, of course. So what we are doing now is looking at the opportunities, both from a patient perspective and the exact indication. We have a very positive data. We have looked into sensitivity analysis in different subgroups and overall groups.

And I do believe that relatively small study could provide the clinical data that we estimate would be sufficient for going back to the authorities. But overall, this, of course, will also require some further analysis with regards to market access conditions as well as general market research. But I think a quarter is probably a good time frame for -- coming back with more concrete feedbacks on the way and the path forward. I should say, I mean there is a huge medical need, and we feel very convinced about the potential for our product in this space. What is maybe more difficult is exactly the framework and that framework is dependent on a number of different aspects, as I said, including access. So hopefully, that answers your question.

[Erik Hultgård, analyst]

And there were two others, if I may?

[Fredrik Tiberg, executive]

Yes. I think Jon can take second question?

[Jon U. Alonso, executive]

Yes. Regarding the -- how much portion it is allocated to CAM2029? Out of the investment we performed in clinical trials, all of it is allocated to CAM2029. I'm talking [ 25% ] of it in area of the 3 indications we have: Acromegaly, PLD and/or GEP-NET. And this is our intention also for next year when during the presentation, I have mentioned that we will increase around SEK 0.1 billion investment in '23 versus '22. And are you taking the third question on Fredrik?

[Fredrik Tiberg, executive]

Well, I can take that basically on the run, so to speak. I mean there -- if you look at all the available data on the number of patients in the U.S. there is quite a bandwidth. And that bandwidth goes from around 1 million up to 1.8 million. And we have tried to -- you state that, that is in the middle of this range. But I think if you're looking at the other companies and how they present the data, they've also shown references across the range. So I think there is no clear answer to exactly how many patients are in treatment right now. But we are happy if it's 1.8 million or we are not, depending on the perspective.

[Operator]

The next question comes from Patrik Ling from DNB.

[Patrik Ling, analyst]

Just a short follow-up. I mean, I heard that you said that you will increase your R&D spend with approximately SEK 100 million over '22. But you also talked about another SEK 100 million in cost increases relating to organization. Was that sales organization? Maybe you could clarify exactly what you said there?

[Jon U. Alonso, executive]

What we said is a part of the SEK 0.1 billion that we would be incrementally investing in R&D. We intend to incrementally invest SEK 0.1 billion in mainly proprietary development for FluidCrystal technology, just to perform some developments there, U.S. organization development, as Fredrik has mentioned, and then there is a component of systems aggregate and structural development to support our corporate development. So these are the four areas in which we are going to invest an additional in the range of SEK 100 million.

[Patrik Ling, analyst]

Okay. So that is R&D plus the other three, that's SEK 100 million in total just so to understand it? So it's SEK 200 million in total?

[Jon U. Alonso, executive]

No, it's SEK 200 million. SEK 100 million in CAM2029 and SEK 100 million in the other concepts.

[Patrik Ling, analyst]

Okay. Right. Got it. Then I also have a small follow-up question. I mean you talked about price and volume mix. Could you say anything about how the trend has looked during Q4? What your average price per patient per month has been? And what you're expecting going into 2023?

[Jon U. Alonso, executive]

We have not disclosed any average selling price, Patrik, and we don't usually do it. What we have mentioned is when you look at our margin, our margin has improved versus the same period last year, and a portion of it, around half of it is simply better country price/mix as we are increasing the volumes in different countries. So this is what it has included. And then usually, in this cost, we are asked which is expected the gross margin, we expect to achieve, and we think that is more or less we are reaching now a margin that we think we can sustain for the future.

[Peter Östling, analyst]

Can you hear me?

[Fredrik Tiberg, executive]

Yes, yes.

[Peter Östling, analyst]

Yes, okay. I was not introduced. This is Peter Ostling from Pareto. It seems like the introduction of the different persons doesn't work really well. But anyway, you can hear me now. Some of them have already been asked and answered. I have one...

[Fredrik Tiberg, executive]

Sorry for the inconvenience.

[Peter Östling, analyst]

Yes. So the operator just figured out that somebody was asking you questions. So okay, I start over. I may have heard it wrong, but I believe that you have mentioned the duration of treatment of -- for Buvidal of approximately 10 months. On the recent Capital Markets Day of one of your competitors, they said that their average duration of treatment had increased from 4.5 and 5 to around 5.5 months. This sounds very short and not much longer than the average treatment duration on oral treatment. Can you comment on this in any way, please?

[Fredrik Tiberg, executive]

I think it's difficult for me to comment on competitive products and how that is working in their context, but I mean, our -- since the start and our launch in our different markets, we have seen that we had a high retention in treatment and based -- I mean, we don't have the granularity as you have in the U.S. market. But based on our estimates from different markets, it is above 80% and in some countries closing in on 90% retention over 12 months. So the average treatment time is, I would say, in the order of 10 months for Buvidal across our markets. We'll see -- I don't think we can say so much about the reasons for the competitive products, but that would be interesting to follow up more in detail later on.

[Peter Östling, analyst]

Exactly. But when you have -- or discussed with Braeburn on the U.S. market dynamics, have you come across any major differences between how the U.S. market would work for a long-acting [indiscernible] European and the Australian experience that you have?

[Fredrik Tiberg, executive]

Well, I think if we take it from another angle, and we're just looking at our Phase III -- the 12-month study that we conducted, which was done across the three continents. So we had both European, U.S. and Australian sites. My recollection was that the -- it was about at least 70% to -- up to 74% depending on how you define the population in retention, and we did not see any significant changes between the markets in that study. Of course, that does not exclude it being different in a real-life setting. But that study was conducted under quite, let's say, real life circumstances.

[Peter Östling, analyst]

Okay. And just another brief one. Will you interact in any way with Braeburn ahead of the potential commercialization in the U.S.? Or will they just do this by themselves 100%?

[Fredrik Tiberg, executive]

Well, I mean, we are working according to our collaboration agreement, and there are -- we have -- of course, we have meetings and other things in our relationship, as we have said before. So we will definitely have both people manage and exchange.

[Peter Östling, analyst]

Okay. Will you or they or you together be more transparent towards the market on what's going on in the U.S. ahead of the launch?

[Fredrik Tiberg, executive]

I cannot give any clear indications there, but we'll see how things develop. I think it will be a very interesting period. So we are trying to be as transparent as we can from our side.

[Operator]

The next question comes from the line of Suzanna Queckbörner, Handelsbanken.

[Suzanna Queckbörner, analyst]

The first one regards the Australian Therapeutic Goods Administration. Is your mission for chronic pain still underway here? And what's the progress you see here?

[Fredrik Tiberg, executive]

Well, with regard to Australia, when we come with an update in sometime, probably before the start of the next quarter. So that is the current situation. We are waiting to update on that.

[Suzanna Queckbörner, analyst]

Okay. So the submission is still submitted?

[Fredrik Tiberg, executive]

Yes, you have the information there. So it's available. But we are -- we will come back as soon as we have relevant information.

[Suzanna Queckbörner, analyst]

Great. And then as a second question, you had 4,000 new patients on Buvidal in Q4. Should we see this as the new normal going into '23?

[Fredrik Tiberg, executive]

I think there is no new normal here. I mean it is varying a little bit between periods, I would say. So you saw that we had about -- I think we added about 2,000 patients in Q3. We are hopeful that we will be delivering good growth over the coming months, and we have that also in our plans. But I would say it's difficult to project. What do you say, Richard. Do you want to...

[Richard Jameson, executive]

Yes, I agree. I mean we know Q3 because the summer period is always a bit slower, so you can't say looking what's going to happen, but yes. In my view it -- yes, we will continue to recruit well in '23.

[Suzanna Queckbörner, analyst]

Okay. And then my final question. In the past, you've given a breakdown of what -- which countries are your largest market. So I was wondering if you could now provide a concentration of maybe your top 10 markets relative to your total Buvidal sales?

[Fredrik Tiberg, executive]

Well, I don't think we have given that detail and it varies over time, but we have said that the top markets are still -- do you want to go in?

[Jon U. Alonso, executive]

So the top market, as Fredrik is mentioning, they are -- at the end of this year is Australia, U.K. and Nordics. We can use this geographical area, Suzanna, and with our top markets at the moment.

[Operator]

The next question comes from the line of Viktor Sundberg from Nordea.

[Viktor Sundberg, analyst]

So I saw this by looking at long-acting buprenorphine has cost advantages in New South Wales. And I just found the argument is very compelling from a cost perspective that you can actually save money from long-acting buprenorphine. But I just wanted to understand if you can use this to push this argument to other countries across Europe in response to austerity measures. I also wondered if you plan to initiate any other health economic studies here in several other European countries? And on the same theme also, will you be hit by U.K. clawback schemes here for branded medicines? Or are you too small for that? Or when could that be a negative factor for you in the U.K., for example?

[Fredrik Tiberg, executive]

Yes. I mean on the first topic and the unlocked study health economical outcomes. I think, yes, I mean, we are using the data also externally. We have a lot of interest from criminal justice systems around Europe as well as from other markets. And here, of course, this data is very valuable. I think in many different settings, the long-acting technologies segment has a clear health care economical analogues, which we are trying to exploit. And we have studies ongoing in different markets. In Germany, for instance, there is studies ongoing in the criminal justice system and also some communications, Richard?

From German, I think we have some publications.

[Richard Jameson, executive]

Yes. Yes, there's a number of -- in both the prison setting and community setting, we have a number of economic studies ongoing.

[Fredrik Tiberg, executive]

So that. No, no, no, he wanted to know about the U.K. austerity measures and how they hit us? I mean in principal, this is a problematic situation for a lot of pharma companies. I mean, it's quite sizable capital that is -- has been presented by the U.K. government. The extent it affects us is not clear yet, but we will definitely risk of being up there in terms of having to pay this levy.

[Operator]

There are no more questions at this time from the telco. So I hand the word back to you, Fredrik.

[Fredrik Tiberg, executive]

Thank you so much. And I think what -- we have a couple of questions here from the listeners, and one is regarding whether or not there are any revenues from IMCIVREE in 2022?

And the answer is no. I mean, our relationship is in regards to the weekly formulation of the same active ingredient. So IMCIVREE is presently approved. It's a once-daily product, and the collaboration we have with Rhythm is for the weekly depot and royalties -- any royalties coming there will be related to the sales of this product once approved.

So I think there is also one question from [indiscernible] about CAM2038 and the withdrawal. I think we have answered those questions. And then from [indiscernible], again, the considerations which we expect to build in the U.S. organization, organically or inorganically?

I would say now that we are following both paths. So we are starting to build up both organically and also looking to see if there is synergistic relationship to be formed through the inorganic pathway.

I think that's -- we also had a question. Well, I do think the other questions have been answered in regards to the chronic pain injection. So if there is no more questions from the call, I'm giving...

Then I would just like to thank you, everybody, for your attention. And I wish you all a very nice Valentine's Day. I just realized that was the case today. So have a great day and looking forward to the next call in May.

[Operator]

This now concludes the call. You may disconnect your lines.