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Camurus Ab
2/14/2023
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 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. So in previous calls with me today is our Chief Financial Officer John Garay and Chief Commercial Officer Richard Jameson. So as I already alluded to, 2029 was a very successful year for Camrys 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% to 156 million and the operating results increased from a minus of 112 million SEK to a positive result of 72 million SEK. This while also investing around half a billion 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. I received three new regulatory approvals and five pricing and market access approvals during the year. Bibidol is now available in 20 countries. and the geographic expansion continues. On the R&D pipeline side, four phase three 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 biblical orders from Egypt and Saudi Arabia after Q3 approvals. And on the other side of the Atlantic, our U.S. licensee, Braeburn, resubmitted the MDA for Brixadi, which shortly thereafter was accepted for review by the FDA. with the PDUFA dates coming up later here in May. So moving in then to R&D, we completed recruitment in our pivotal phase three trial of CAM 2029 in ACRO and passed the milestone of 100 patients randomized in the Sorrento phase three 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 the director of sustainability, Edith Rehnström, as well as new members of Canberra's team. Examples of more specific activities in the quarter were medical education efforts for healthcare professionals in Ukraine to support treatment with Duvidal, 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.
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 the next slide, we can see the main components of our operating result, once revenue has already been covered by Fredrik. Gross margin improved 496 basic points in the quarter, driven by, firstly, scrap reduction in our operations, delivering 260 basic points, and secondly, better country price mix and efficiencies of higher volumes delivered in the rest. In total, gross margin delivered 240 million SEC in the quarter, where full year gross margin reached 89.2%. Total OPEX reached 223 million SEK, 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 Wubidal into new markets. Administrative expenses aligned with corporate evolution to substantiate company development. And thirdly, R&D progress in the three indications of our CAN 2029 program, where acromegaly patient recruitment was completed during early Q422. On a full year basis, R&D investment has been 474 million sec, aligned with half a billion sec range indicated earlier this year. Company operating result became positive by 19 million sec in the quarter and 72 million sec 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 566 million SEC delivered in a 37% growth versus same period prior year. Camurus generated 46 million SEC cash in the quarter, mainly driven by company operations generating 32 million SEC Improvement in working capital generating 14 million SEK and warrants program exercise by employees generating 4 million SEK. As end of quarter and year, Camurus has no debt. Our guiding principles for capital allocation continue being reinvesting in our business to accelerate movable market penetration and geographical expansion, as well as bringing Can2029 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 1,530 million SEC to 1,650 million SEC, including anticipated milestone payment following BRICSAD's NDA approval in the United States by a value of $35 million. and profit before taxes in the range of 425 million SEK to 525 million SEK. 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 at risk, and we are planning to address certain market access hurdles. 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 CAM 2029 to market the sooner the better in the range of 0.1 billion SEC versus prior year, and new proprietary development relating to fluid crystal technology, U.S. organization development, systems upgrade, and structural development to support company growth in the range of 0.1 billion SEC 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, John. So move up to a commercial development update. We ended the year with record Buberdale sales in the quarter of 267 million sec, 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. And it's important to note that the underlying in-market Bufordale 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 UK 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. As Frederick 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 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 CAMRAS financial results in 2023 or to a significant extent impact the company's long-range financial plan. CAMRAS is evaluating further clinical development of count 2038 in the treatment of chronic pain, taking into consideration the positive phase three results and the fact that this patient population of the variation that we apply for already has access to Bufadil for the treatment of their opioid dependence. Finally, importantly, we look forward to the approval decision for Brixardi in the US later in the year. As we communicated previously, Braeburn has an FDA acceptance of the Brixardi 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 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. Brixardi and Bovedal 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 on the table on the right. So we look forward to BRICS-RDB becoming available to U.S. patients. And on that, I will hand back to Frederick for the R&D pipeline update.
Thank you, Richard. I will focus this update on the Phase III program for CAM-2029. which as you know is our subcutaneous octreotype depot under development for treatment of three rare disease indications acromegaly gastro enteropancreatic neuroendocrine tumors is the largest indication here referred to as getnet and then polycystic liver disease pld the goal with this development is to come up with the 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 CAMP 2029, which we have shown previously, including two ongoing phase three studies in Acromegaly, a phase three study in Gepnet, and the 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 3 AcroEnova trial, and our enrollment goal was reached also in the Phase 3 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 GEPT-Net, we reached a milestone of more than 100 out of 302 patients enrolled in the Sorrento trial. which is the largest randomized control study of somatostatin analog ever conducted in this important disease area. Our goal here is to demonstrate superiority in 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 US and Europe. So we have a very exciting year ahead with top-line phase three 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 and then submission of the first regulatory approvals 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 pre-launch preparations in the company with focus on the acromegaly indication. Commercial manufacturing is now established and validated for both the pen and pre-filled 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 US in a stepwise process. So CAM 2029 in our view represents a very attractive opportunity with high market potential, particularly in the US, 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 cam 2029 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 cameras 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 US approval decision for Bixari is expected in May. In addition to this, we have three phase three studies progressing in Acromegaly and Gepnet, 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, as well as our sustainability framework, and reached 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 Byggdahl Regulatory and PMA approvals, and the long anticipated approval and potential launch of BrickSiding in the U.S. In the R&D pipeline, we've already covered the phase three 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 RYTHMS Phase 3 study of our weekly set melanotype 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 CAM 2029 in the US, where we see great market potential. So 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 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star 5 again on your telephone keypad. The next question comes from Victor Sundberg from Nordea. Please go ahead.
Yes, hi and thank you for taking my questions. So I noticed on the top line that guidance is a billion-sec 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, Victor. I'll leave it over to John to respond to that.
Thanks a lot, Frederik, and thanks a lot, Victor, 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 Victor.
Okay thank you and also you do include the 35 billion milestone potentially from Braeburn Is that stemming from that you communicated that Braeburn has had an inspection from the FDA already before they resubmitted the application or why do you feel so confident to include that in your guidance for this year?
I can take that Victor. I think that based on the process that has taken place and that includes the fact that the manufacturer was was inspected or we learned that that had been taking place prior to the submission. We feel increasingly confident that there may or should be or is 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 and just a final question. In the UK 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 the Nordics. So 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 UK in how you think that the ramp-up will happen? now that I guess most patients have reimbursement for BoobyDoll in the UK. Thanks.
Yeah, I'll pick this question up, Victor. There's a couple of indications for UK 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. So 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.
The next question comes from Eric Hultgaard from Carnegie. Please go ahead. Eric Hultgaard, 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 how much is invested in CAM 2029 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 US. That seems a bit low compared to a similar number competitive to you provided a couple of months back at the capital market stage. 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. 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. So, 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. And we presented this strategy and aligned it with representatives of EMA prior to submission. And this was also based of course on the phase three data that we had. But based on the CHMP feedback we had recently, and some internal discussions around that, we decided to withdraw the application. because one of the considerations there was that the patients in this population already have access for but 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 very positive data we have looked into sensitivity analysis in different subgroups and overall groups and 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 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, you know, a quarter is probably a good timeframe 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. So hopefully that answers your question.
Yes, thank you. There were two others, if I may.
Yes. I think John can take the second question.
Yeah. Regarding how much portion, Eric, is dedicated to Khan 2029, out of the investment we perform in clinical trials, All of it is dedicated to come 2029. I'm talking 25% of it in either of the three indications we have, Acromegaly, PLD, and OrgEvNet. And this is our intention also for next year when during the presentation I have mentioned that we will increase around 0.1 billion second investment in 23 versus 22.
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 US, there's quite a bandwidth. And that bandwidth goes from around 1 million up to 1.8 million. And we have tried to use data 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 have, 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 or we are not depending on the perspective.
Okay, great. Thank you.
Further questions?
The next question comes from Patrick Ling from DNB. Please go ahead. The next question comes from Patrick Ling from DNB. Please go ahead.
Yeah, hi, Patrick 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 100 million over 2022. But you also talked about another 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 0.1 billion SEC that we would be incrementally investing in R&D. We intend to incrementally invest 0.1 billion SEC in mainly proprietary development for full crystal 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 structure development to support our corporate growth. So these are the four areas in which we are going to invest an additional in the range of 100 million SEG.
Okay, so that is R&D plus the other three, that's 100 million in total, just so I understand it. No, it's 200 million in total.
It's 200 million, 100 in 2019 and 100 in the other concepts.
Okay, great, got it. Then I also had 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?
We have not disclosed any average selling price, Patrick, 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 in growth. And then usually in this course, we are asked, which is the expected 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.
Okay, great. Good. Thank you. Those were the two questions I had. Thank you very much.
Thank you very much.
Hello.
Hello.
Can you hear me?
Yes.
Yes, okay. I was not introduced. This is Peter Rosling from Pareto. It seems like the introduction of the different... person's doesn't work really well but anyway you you can hear me now thank you for taking my question some of them have already been asked and answered I had one and I please state your name and company please go ahead sorry for the inconvenience yes the operator just figured out that somebody was asking a question so okay I start over I may have heard wrong but I believe that you have mentioned the duration of treatment of for Bovidal 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 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 the 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 and based. I mean, we don't have the granularity as you have in the US market, but based on our estimates from different markets, it is about 80 percent. And in some countries closing in on 90 percent retention over 12 months. So 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 competitive product, but that would be interesting to follow up more in detail later on.
Exactly. When you have discussed with Braeburn on the US market dynamics, have you come across any major differences between how the US 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 and we're just looking at our phase three, the 12 month study that we conducted, which was done across the three continents. So we had both European, US and Australian sites. My recollection was that it was about I think 70%, 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.
Okay. Okay, thank you. And just another brief one. Will you interact in any way with Brayburn ahead of their potential commercialization in the US, or will they just do this by themselves 100%?
Well, I mean, we are working according to our collaboration agreement, and there are, we have, of course, we have a meetings and other things in our relationship as we have said before. So we will definitely have both information and exchange.
Will you or they or you together be more transparent towards the market on what's going on in the US 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 are trying to be as transparent as we can from our side.
Thank you. Thank you, guys.
The next question comes from the line of Susanna Queckborner, Handelsbanken. Please go ahead, your line is open.
Hello, Susanna Quackbrenner, 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? And 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, so that is the current situation. We're waiting to update on that.
Okay, so the submission is still submitted as such?
Yeah, you have the information there, so it's available, but we will come back as soon as we have the relevant information.
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 2023?
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 2000 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?
I agree. I mean, we know Q3 because the summer period is always a bit slower. So you can't say routinely it's going to happen. But yeah, in my view, we will continue to accrue well in 23.
Okay. And then my final question. In the past, you've given a breakdown of which countries are your largest markets. I was wondering if you could now
provide a a concentration of maybe your top 10 markets relative to your uh total um buberdoll sales well i i don't think we have given that detail and it you know varies over time but we have we have said that you know the top markets are still do you want to go in so the the top market as frederick is mentioning they are at the end of this year is australia
UK and Nordics. We can use this Geographic Galleria Susanna and this is our top market at the moment.
Okay, thank you very much.
The next question comes from the line of Victor Sundberg from Nordea. Please go ahead, your line is open.
Yes, hi, thank you for taking a follow-up. So I saw this study by Ling et al. looking at long-acting buprenorphine and its cost advantages in New South Wales. And I just found the arguments 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 UK 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 UK, for example? Thanks.
Yeah, 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 you know in many different settings the long-acting technologies segment has a clear healthcare economical advantages 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 the German I think we have some publications so yes yes there's a number of in both prison setting and community setting we have a number of economic studies ongoing so that
Was your question addressed Victor?
No, he wanted to know about the UK 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 UK 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.
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. I have a couple of questions here from the listeners. One is regarding whether or not there are any revenues from IMSEVRE in 2022. The answer is no. relationship is in regards to the weekly formulation of the same active ingredients. So IMSEBRI as presently approved is 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 Johan Håkan Kindring about the Camp 2038 and the withdrawal. I think we have answered those questions. And then from Bertrand again, the considerations with respect to building the US 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 we also have a question. Well, I think the other questions have been answered in regards to the chronic pain detection. So if there is no more questions from the call, I'll give it. Dan, 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.