Welcome to Camurus Q4 Report 2022. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. I will hand the conference over to CEO Fredrik Tiberg.
Thank you so much. 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. With this note of caution, let's move into today's agenda. We'll start with a summary of our achievements in 2022 and the fourth quarter, then 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. As in previous calls, with me today is our Chief Financial Officer, Jon Garay, and Chief Commercial Officer, Richard Jameson.
As I already alluded to, 2029 was a very successful year for Camurus, where we've 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% to SEK 956 million, and the operating results increased from a - SEK 112 million to a positive result of SEK 72 million. This while also investing around SEK 500 million in the R&D pipeline and future growth of the company. We continued strengthening our leadership in long-acting opioid dependence treatment across Europe, Australia, and the MENA, received three new regulatory approvals and five pricing and market access approvals during the year. Buvidal is now available in 20 countries, and the geographic expansion continues.
On the R&D pipeline side, four 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. 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 profit. We received the first Buvidal orders from Egypt and Saudi Arabia after Q3 approvals. 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 dates coming up later here in May.
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. 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 a 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 healthcare 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 a 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. With this brief intro, I will hand over to Jon to give an update on the financial performance and outlook for 2023.
Thanks a lot, Fredrik. Good afternoon, everyone. We would like to share with you now the main highlights of our financial performance this quarter. If we move to the 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, a scrap reduction in our operations, delivering 260 basis points. Secondly, better country price mix and efficiencies on higher volumes delivered in 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 investment to support market penetration in own territories and expansion of Buvidal into new markets. Administrative expenses aligned with corporate evolution to substantiate company development. Thirdly, R&D progress in the three indications of our CAM2029 program, where acromegaly patient recruitment was completed during early Q4 2023. On a full-year basis, our R&D investment has been SEK 474 million, aligned with SEK 500 million range indicated earlier this year. Company operating result 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 fluctuate 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. As 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. 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-SEK 1,650 million, including anticipated milestone payment following Brixadi NDA approval in the United States by a value of $35 million. Profit before taxes in the range of SEK 425 million-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 hazards.
From a strategic investment point of view, while 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. New proprietary development relating to FluidCrystal technology, U.S. organization development, systems upgrade, and structure 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.
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 a 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 wholesaler year-end. It's important to note that the underlying in-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.
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. Our market expansion also continued. As Fredrik said earlier, Buvidal is now available in 20 countries across Europe, Australia, and MENA. 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. 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.
Looking ahead, we expect several new markets to open in 2023 to further our expansion with five market authorization applications under review and six PMA submissions. We also updated yesterday on the withdrawal of the 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 Braeburn's financial results in 2023 or to a significant extent impact the company's long-range financial plan. Braeburn 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 applied for already has access to Buvidal for the treatment of their opioid dependence.
Finally, 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. 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 that's led firstly, to the elimination of DATA waiver for the prescribing of buprenorphine and the removal of the restriction on the number of patients a physician 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. You can see this outlined in the table on the right. We look forward to Brixadi becoming available to U.S. patients. On that, I will hand back to Fredrik for the R&D pipeline update.
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 three rare disease indications. Acromegaly, gastroenteropancreatic neuroendocrine tumors is the largest indication here referred to as GEP-NET, 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. In the case of PLD or 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 a phase 2B 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 a somatostatin analog ever conducted in this important disease area. Our goal here is to demonstrate superiority and progression-free survival. 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. 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 readouts of the long-term safety trial, and in the second half of the year. Submission of the first regulatory approval around the end of the year. These are all acromegaly points and we'll come back to the other programs later on. In parallel with the clinical work, we have been ramping up pre-launch preparations in the company is with focus on the acromegaly indication. Commercial manufacturing is now established and validated for both the pen and prefill syringe product presentations.
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. We are starting to build our own commercial infrastructure in the U.S. in a stepwise process. CAM2029, in our view, represents a very attractive opportunity with high market potential, particularly in the U.S., which 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. In conclusion, Braeburn has finished 2022 with a solid fourth quarter. We are 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 three phase III studies progressing in acromegaly and GHD, with the first results 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. 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. 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 2024.
In our partnerships, an anticipated highlight is the top-line results in Rhythm's phase three study of our weekly setmelanotide formulation for treatment of genetic obesity diseases. On the corporate side, we are, of course, as a highlight, starting to build the commercial infrastructure for CAM2029 in the U.S., where we see great market potential. With this positive outlook, let's move over to Q&A. Operator, can you please take over?
If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Viktor Sundberg from Nordea. Please go ahead.
Yes. Hi, thank you for taking my questions. 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 we give more color on the assumptions here? Thanks.
Yeah, of course, Viktor. I'll leave it over to Jon to respond to that.
Thanks a lot, Fredrik, thanks a lot, Viktor, for your question. 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 implementing during 2023, 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. Thanks a lot, Viktor.
Okay. Thank you. Also, you do include a $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? Why do you feel so confident, I mean, to include that in your guidance for next or for this year, sorry?
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 it's likely to have an approval at this time. Of course, there is never any guarantees, but that's the reason we have included it in the guidance.
Okay, thanks. Just a final question. In the U.K., I think you showed an ambition to reach a bit over 40,000 patient if the penetration of this market would be similar to Australia and the Nordics. I just wanted to understand a bit more how fast 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. in how you think that the ramp-up will happen, now that I guess most patients have reimbursement for Buvidal in the U.K.? Thanks.
I'll pick this question up, Viktor. I mean, there's a couple of indications for U.K. why we think it should accelerate now. Firstly, the monies, 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 England was by the funding issue. If we reflect on that, then we should see that acceleration happen relatively quickly in the coming, I'd suggest two years or so, hopefully.
Thank you very much.
Shall we move over to the next?
Take some questions here.
In absence of, I don't know if this AI system works here, but I have a couple of questions here from the audience. One of these questions was, it would be helpful if we could elaborate on the withdrawal of the CAM2038 application in chronic pain. You see question queue here.
Yeah. We can see that Suzanna is on the queue. Viktor, Erik, Patrik.
Can the operator help us with this?
The next question comes from Erik Hultgård from Carnegie. Please go ahead. Erik Hultgård, Carnegie, your line is now unmuted. Please go ahead.
Thank you. I hope 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 you need to conduct to resubmit chronic pain in Europe? That's my first question. 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.
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. I was wondering what the source of that number is and whether it's patients currently on treatment or patients that has been on therapy over the past 12 months. Thank you.
Thank you so much, Erik. I will try to answer the question. I mean, going first, starting out with the chronic pain application. I mean, the origin of this was that we saw an opportunity to improve access to pain physicians and, you know, get recognition for the treatment effect on chronic pain in this population with the extended label. We presented this strategy and aligned it with representatives of EMA prior to submission. You know, this was also based, of course, on the phase III data that we had. Based on the CHMP feedback we had recently, we and some internal discussions around that, we decided to withdraw the application.
One of the considerations there was that the patients in this population already have access for Buvidal, but for treatment of opioid dependence, of course. What we are doing now is looking at the opportunities both from a patient perspective and the exact indication. We have very positive data. We have looked into sensitivity analysis in different subgroups and overall groups. I do believe that a relatively small study could provide the clinical data that we estimate would be sufficient for, you know, going back to the authorities. Overall, this of course, will also require some further analysis with regards to market access conditions and as well as general market research.
I think, you know, a quarter is probably a good time frame for coming back with more concrete feedback 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. Hopefully that answers your question.
Yes. Thank you. There were two others if I may.
Yes. I think Jon can take the second question.
Regarding the how much portion, Erik, is dedicated to CAM2029. Out of the investment we perform in clinical trials, all of it is dedicated to CAM2029 and talking 25% of it in either of the three indications we have, acromegaly, PLD and/or GEP-NET. 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 2023 versus 2022. I think the third question, Fredrik.
Yeah. Well, I can take that basically on the run, so to speak. I mean, 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. We have, you know, tried to use data that is in the middle of this range, but I think if you're looking at other companies and how they present the data they have, they've also shown references across the range. I think there is no clear answer to exactly how many patients are in treatment right now. We are happy if it's 1.8 million or we are not, depending on the perspective.
Okay, great. Thank you.
Further questions? I see.
The next question comes from Patrik Ling from DNB. Please go ahead.
Yeah. Hi, Patrik here at DNB. 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 2022. You also talked about another SEK 100 million in cost increases relating to organization. Was that sales organization? Maybe you can clarify exactly what you said there.
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. There is a component of systems aggregate and structure development to support our corporate growth. These are the four areas in which we are going to invest an additional in the range of SEK 100 million.
Okay. That is R&D plus the other three. That's SEK 100 million in total.
No.
I understand it.
No.
It's SEK 200 million in total.
It's SEK 200 million.
Oh, okay. Got it.
100 in CAM2029 and 100 in the other concepts. Yeah.
Okay. Great. Got it.
Yeah.
I also had a small follow-up question.
Mm-hmm.
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?
We have not disclosed any average selling price, Patrik, 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. A portion of it, around half of it, is simply better country price mix as we are increasing the volumes in different countries. This is what it has improved. Then usually in this course, we are asked which is expected gross margin we expect to achieve. We think that is more or less we are reaching now a margin that we think we can sustain for the future.
Okay. Great. Good. Thank you. Those were the two questions I had. Thank you very much.
Thank you very much.
The next-
Hello?
Hello.
Can you hear me?
Yes. Yes.
Yes. Okay. I was not introduced. Thi s is Peter Rosling from Pareto. It seems like the introduction of the different persons doesn't work really well. Anyway, you can hear me now. Thank you for taking my question. Some of them have already been asked and answered. I had one. I
Please state your name and company. Please go ahead.
Hi, Peter. Sorry for the inconvenience.
Yeah. The operator just.
Mm-hmm
figured out that somebody was asking you a question. Okay, I start over. I may have heard wrong, but I believe that you have mentioned the duration of treatment 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 four and a half and five to around five and a half 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?
Thank you, Peter. I think it's difficult for me to comment on a competitor product and how that is working in their context. I mean, our since the start and our launch in our different markets, we have seen that we have a high retention in treatment. I mean, we don't have the granularity as you have in the U.S. market. Based on our estimates from different markets, it is about 80% and in some countries, closing in on 90% retention over 12 months. The average treatment time is, I would say, you know, 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 competitor product, but that will be interesting to follow up more in detail later on.
Exactly. 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 visa, the European and the Australian experience that you have?
Well, I think if we take it from another angle, we're just looking at our phase III 12-month study that we conducted, which was done across the three continents. We had both European, U.S. and Australian sites. My recollection was that it was about think %70%, so up to 74, depending on how you define the population in retention. We did not see any significant changes between the markets in that study. Of course, that's not excluded being different in a real-life setting, but that study was conducted under quite, let's say, real-life circumstances.
Okay. Okay. Thank you. Just another brief one. Will you interact in any way with Braeburn ahead of their potential commercialization in the U.S., or will they just do this by themselves 100%?
Well, I mean, we are working according to our collaboration agreement. We have, of course, we have meetings and other things in our relationship, as we have said before. We will definitely have both information and exchange.
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?
I cannot give any clear indications there, but we'll see how things develop. I think it will be a very interesting period. We've, we are, you know, trying to be as transparent as we can from Camurus.
Okay.
From our side. Thank you.
Okay. Yeah. Thank you, guys.
The next question comes from the line of Suzanna Queckbörner, Handelsbanken. Please go ahead. Your line is open.
Hello, Suzanna Queckbörner, Handelsbanken here. Thank you for taking my questions. The first one regards the Australian Therapeutic Goods Administration. Is your submission for chronic pain still underway here? What's the progress you see here?
Well, with regards to Australia, we will come with an update, sometime probably before the start of the next quarter. That is the current situation. We're waiting to update on that.
Okay. The submission is still submitted as such?
Yeah. You have the information there, so it's available. We will come back as soon as we have relevant information.
Great. As a second question. You had 4,000 new patients on Buvidal in Q4. Should we see this as the new normal going into 2023?
I think there is no new normal here. I mean, it is varying a little bit between periods, I would say. You saw that I think we added about 2,000 patients in Q3.
Yes.
We are hopeful that we will be, you know, delivering good growth over the coming months, and we have that also in our plans. I would say it's difficult to project. What do you say, Richard? Do you want to have
Yeah. I agree. I mean, we know Q3, 'cause the summer period is always a bit slower, you can't say routinely it's gonna happen. Yeah. In my view, yeah. We will continue to recruit well in 2023.
Okay. Then my final question. In the past, you've given a breakdown of what which countries are your largest markets. I was wondering if you could now provide a concentration of maybe your top 10 markets relative to your total Buvidal sales.
Well, I don't think we have given that detail and it, you know, varies over time. We have said that, you know, the top markets are still... Do you want to go in?
The top market, as Fredrik is mentioning, they are at the end of this year is Australia, U.K., and Nordics. We can use these geographical areas, Suzanna, and these are our top markets at the moment.
Okay. Thank you very much.
The next question comes from the line of Viktor Sundberg from Nordea. Please go ahead, your line is open.
Yes. Hi. Hi. Thank you for taking a follow-up. I saw this study by Ling et al. looking at long-acting buprenorphine and its cost advantages in New South Wales. I just found the arguments very compelling from a cost perspective that you can actually save money from long-acting buprenorphine. 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. 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?
When could that be, you know, a negative factor for you in the U.K., for example? Thanks.
Yeah. I mean, on the first topic, the UNLOCK study health economic 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. Here, of course, this data is very valuable. I think, you know, in many different settings, the long-acting technologies segment has clear healthcare economic advantages which we are trying to exploit. 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 the German, I think we have some publications.
Yes. Yes. There's a number of, in both prison setting and community setting.
Yeah
... we have a number of economic studies ongoing.
that
U.K.
The-
Was your question addressed, Viktor?
No, no. He wanted to know about the U.K. austerity measures and how they hit us. I mean, in principle, this is a problematic situation for a lot of pharma companies. I mean, it's quite a sizable cut that 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.
That's fine.
Okay. Thank you very much.
There are no more questions at this time from the telco, so I hand the word back to you, Fredrik.
Thank you so much. 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. IMCIVREE is presently approved. It's a once-daily product. The collaboration we have with Rhythm is for the weekly depot. Royalties, any royalties coming there will be related to the sales of this product once approved. I think there is also one question from Jon Håkan Lindroth about CAM2038 and the withdrawal. I think we have answered those questions.
From Bertrand again, the considerations with respect to building 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 a synergistic relationship to be formed through the inorganic pathway. I think that's. We also have a question. Well, I think the other questions have been answered in regards to the chronic pain indication. If there is no more questions from the call, I'll give in. I would just like to thank you everybody for your attention. I wish you all a very nice Valentine's Day. I just realized that was the case today.
Have a great day, and looking forward to, the next call in May.
This now concludes the call. You may disconnect your line.