Welcome to Camurus Q4 Report 2024. For the first part of the conference call, the participants will be in listen-only mode during the question-and-answer session. Participants are able to ask questions by dialing #5 on the telephone keypad. Now I will hand the conference over to CEO Fredrik Tiberg . Please go ahead.
Thank you so much, Einar, and good day, everyone, and welcome to Camurus' full year and fourth quarter earnings call. Before starting, please note our forward-looking statements, so we will begin the presentation today with a short business highlights, then review the financial performance, followed by commercial and R&D updates, and of course, then Q&A. As previously, I'm joined in the call by Jon Garay , CFO, and Richard Jameson , Chief Commercial Officer.
Camurus had a rewarding 2024 with good performances across the business. This resulted in high growth and profitability alongside advances of key pipeline programs. In parallel, we continued the geographic expansion with the establishment of Camurus Inc. in the U.S. Importantly, we remain on track to deliver our five-year vision of five-fold revenue growth from 2022 and an approximate 50% operating margin in 2027.
As a reflection of the solid performance during the year, we delivered continued strong operating revenue growth, as well as, you can see on the right-hand side here, sustainable high profitability. Our fourth quarter results exceeded previous estimates, with Buvidal growing at double-digit rate in own territories and Brixadi finishing the first full year with strong fourth quarter. Additionally, we established a fully operational U.S. commercial organization, as prepared for the launch of CAM2029 in acromegaly.
On the development side, regulatory reviews of CAM2029 continued in the U.S. and the EU, with a temporary setback in the U.S. in the form of a complete response letter from the FDA relating to an inspection of a third-party manufacturing facility. I will come back to this later in the presentation. In parallel with the regulatory reviews, our clinical studies Sorrento and Positano continued to advance.
Before the new year, we initiated a new clinical study of our once-monthly semaglutide GLP-1 product. On the corporate side, we delivered solid financial performance, positioning the company for further expansion and growth in 2025. With this short introduction, I'll leave the word over to Jon for a financial update.
Thanks a lot, Fredrik, and good afternoon, everyone. During the quarter, Camurus continued its development, delivering strong growth and financial performance. Now, I would like to share the key financial highlights of this quarter. At the end of the quarter, Camurus achieved SEK 553 million total revenue, delivering a growth of 48% versus same period last year, with product sales of SEK 469 million growing 28% versus prior year and 11% versus prior quarter. Additionally, Brixadi's sales in the United States represented SEK 83 million royalty income, growing 43% versus prior quarter.
Looking at full-year results, Camurus reached SEK 1,868 million total revenue, representing a growth of 9% versus prior year. Excluding one-time revenues in 2023 related to Brixadi approval in the U.S. by FDA, total revenue grew 42% versus prior year, and Brixadi royalty represented SEK 212 million.
During 2024, the company achieved an earnings per share after dilution of SEK 7.20, equivalent to a profit after tax of SEK 429 million, and company cash position progressed positively, ending at SEK 2.85 billion. Moving to the next slide, we can see the main components of our profit before taxes. Company gross margin reached 94% in the quarter, representing an improvement of 267 basis points versus same period prior year, driven by three major factors. Firstly, supply chain efficiencies driven by Buvidal volumes scale-up represented 181 basis points. Secondly, 96 basis points are driven by Brixadi royalty. And thirdly, FX represented a negative impact of 10 basis points.
Total OpEx reached SEK 357 million, representing a 4% decrease versus same period prior year, driven by following factors. Marketing and distribution investment to support market penetration in own territories, expansion of Buvidal into new markets, and U.S. operations grew 40% to SEK 157 million . Administrative expenses, aligned with corporate evolution to substantiate company development, grew 48% versus same period last year to SEK 25 million . R&D investment reached SEK 167 million , decreasing 27% versus same period prior year, driven by lower social security costs related to long-term safety plans and lower study costs in our clinical trials.
On a full-year basis, R&D investment reached SEK 684 million , equivalent to 37% of total company revenue. During the quarter, the company explored a potential transaction incurring one-time expenses of SEK 8 million regarding advisory fees that are reported in other operating expense lines. Company profit before taxes reached SEK 186 million , growing SEK 204 million v ersus Q4 2023.
On a full-year basis, company profit before taxes reached SEK 553 million , which, excluding one-time M&A revenue impact, represents an improvement by SEK 409 million , increasing 286% versus 2023. company's cash position at quarter end was SEK 2.85 billion. Camurus improved its cash position by SEK 101 million during the quarter, driven by the following four factors. Firstly, company operations generated SEK 166 million. Secondly, third window of ESOP 2124 program generated SEK 18 million. Thirdly, working capital consumed SEK 63 million. And fourthly, investing activities required SEK 20 million. As of the end of the quarter, Camurus has no debt.
Moving now to 2025 guidance, the company has considered the following factors when providing 2025 financial guidance: market conditions, the current macroeconomic environment, continued investments aligned with the strategic vision 2027, in which we imply R&D will continue approximately flat in the level of SEK 0.65 billion, and incremental investment of approximately SEK 0.35 billion to fully deploy U.S. operations, launch Oczyesa globally, and support company growth. Social security costs regarding company long-term incentive programs will vary with the share evolution.
From a capital expenditure point of view, the company will invest about SEK 0.2 billion in the next two years to develop a second manufacturer to enhance manufacturing capabilities and support new product launches. Camurus' full-year 2025 outlook is as follows: total revenues in the range of SEK 2.7 to 3 billion , representing a growth of 45% to 61%. Profit before tax in the range of SEK 0.9 to 1.2 billion , representing an increase of 63% to 117%. All in all, Camurus closes 2024 with a strong financial position, solid operational performance, interesting growth opportunities, and remains on track to deliver SEK 4.5 billion total revenue at circa 50% operating margin by 2027. Having said that, I would like to pass the word to Richard. Thank you, everyone, for your attention.
Thank you, Jon. I will start with the business in Europe, Australia, and the Middle East region. In the fourth quarter, the year finished strongly with Buvidal sales of SEK 469 million , which was 11% versus the previous quarter and 28% over the previous year. For the full-year sales of Buvidal were SEK 1.65 billion , a growth of 27% versus the previous year. At the end of the year, we estimate that 60,000 patients were currently being treated with Buvidal.
In the EU, this was led by the large European markets with the U.K., France, Germany, and Spain. The strong performance was a result of continued execution of key programs that drive penetration and improve access to Buvidal, resulting in continued market share gain and new patient recruitment across all geographies. In Australia, Buvidal is now established as a first-line treatment.
The market share of long-acting Buprenorphine in Australia is now estimated at 32% of all patients, and Buvidal has clear leadership in this segment. This is supported by the efforts to improve capacity and access for patients, for example, with a growing number of pharmacies that now have been trained and are now administering Buvidal, which creates space for new patients at clinics.
Our market expansion continued, and in the quarter, we had three new reimbursement approvals that were received in Switzerland, Portugal, and Luxembourg, and we'll launch Buvidal in early 2025 in those countries. Additionally, four other regulatory applications are under review. Now, moving across to the U.S., first, a reminder of the U.S. market, where there are an estimated 6-7 million people with opioid use disorder, of which an estimated 2.3 million seek treatment in a year, and 1.8 million of those are on Buprenorphine.
In the fourth quarter, Brixadi has strong growth. Net sales grew 43% versus the previous quarter, resulting in royalties of SEK 83 million and SEK 212 million for the full year. The launch continues to outperform previous product launches in this segment. Patient capture was primarily from the large sublingual Buprenorphine segment, while the remainder from transfers from other long-acting products and direct initiations into treatment by Brixadi.
So 15 months from the initial launch, Brixadi market share has reached approximately 25% of that long-acting segment, and the peak market share potential for Brixadi is estimated to be above $1 billion. Now, to support both Buvidal and Brixadi, the evidence base for effectiveness in different treatment settings and the economic outcomes continues to grow.
In the quarter, we have three important publications. First was an exploration of treatment outcome by quantitative urine measures that shows emphasized treatment effect in patients using high levels of opioids. Secondly, a naturalistic study showed a clear preference from patients for Brixadi injection over other long-acting injectables. And finally, a paper that explored healthcare professional perceptions that showed high satisfaction for long-acting Buprenorphine compared to both methadone and daily sublingual Buprenorphine. And this growing evidence base continues being shared through our wide-ranging medical education programs and at leading congresses. And on that note, I'll hand back to Fredrik for an R&D update.
Okay, thank you. I will start with CAM2029 and the developments across the three target indications: acromegaly, gastroenteropancreatic neuroendocrine tumors , and polycystic liver disease, PLD. In acromegaly, the two ACROINNOVA phase III trials have been successfully completed with positive results. The last few patients in the extension study of ACROINNOVA 2 will be completing treatment in May 2025, followed by data readout and results. In gastroenteropancreatic neuroendocrine tumors , treatment of patients in the randomized active control Sorrento trial continued to progress, with generally positive experiences communicated from participant investigators and clinical staff.
Based on an indication of a slower than expected rate of tumor progression in the study, especially in this study population, of which a majority had advanced disease of grade II or III when included in the trial, the estimated time for reaching the target of 194 events for reading out the primary results was updated to late 2025 or early 2026. In polycystic liver disease , the last patients entered into the final stages of the randomized placebo-controlled Positano trial, and they are now in the process of completing the core phase of the study, with primary results expected in the second quarter of this year.
On the regulatory side, we look forward to an FDA approval, or we looked forward to an FDA approval on the PDUFA date of 21 October, after late-stage labeling discussions with the agency. Instead, we received a Complete Response Letter from the FDA, which solely related to a GMP inspection at the third-party manufacturing facility. No concerns were related to CAM2029's safety, efficacy, or chemistry manufacturing and controls. The manufacturer has responded to the observations and is currently waiting for the FDA to share the Establishment Inspection Report following a recent OAI classification.
This will be used to decide the timing of the NDA resubmission, which tentatively is planned for the first half of this year. In the EU, our market authorization application advanced according to plan, and we expect a CHMP opinion around the mid-year 2025, followed by a decision by the European Commission. On the medical side, efforts have been focused on medical affairs and disseminating results and data from our ACROINNOVA phase III studies.
The main result of the ACROINNOVA 1 trial was published in the Journal of Clinical Endocrinology and Metabolism in October, and multiple meeting abstracts and new manuscripts have recently been completed and being submitted. Our medical and MSL teams have been very active informing about CAM2029, as well as Camurus more generally, to the broader acromegaly community and planning for several important events in 2025.
Camurus will be present at key scientific conferences and meetings in 2025, with presentations and symposia, as shown in this slide here. We are experiencing a large interest in learning more about the product and doing everything we can to make it available to patients as soon as possible. On the commercial side, we continue to prepare for the launches in the U.S. as well as in select countries in the EU.
The opportunity for CAM2029 is considerable, with potential peak sales across indications and geographies estimated to above $2 billion annually. In the early development pipeline, we advanced a number of different programs for long-acting incretins, for instance, including a monthly semaglutide formulation. A clinical trial application was approved in the fourth quarter, and the first patients were enrolled before the end of the year. The study is now up and running, evaluating pharmacokinetics, pharmacodynamics, including weight loss and safety of CAM2056 versus current commercially available weekly semaglutide in participants with overweight or obesity who are otherwise healthy.
In the first part of this study, we are comparing two dosing schedules of CAM2056 against the dose titration to label schedule, which is existing for weekly semaglutide. Following this, different escalation regimes will be explored.
Aside from the approved indication of type 2 diabetes and weight management, I'm sure you have learned that GLP-1 agonists like semaglutide may also have potential in inflammation, neuropsychiatry, and of keen interest to Camurus for the potential treatment of substance use disorder. Before wrapping up, I can also mention that we have finalized the setting up of our new headquarters in Lund, where we are currently sitting. We have built here a state-of-the-art lab tailored to our different needs from early to late-stage development. This will, of course, be used here to support our planned business expansion during the coming years.
Based on a very successful 2024, we have laid the foundation for 2025, where we expect to see increased Buvidal penetration, acceleration of Brixadi sales in the U.S., obtain approvals for CAM2029 in acromegaly, deliver clinical results for CAM2029 in polycystic liver disease, and also for the new program CAM2056. In addition, we plan to diversify our business through business development activities and overall contributing to a positive financial outlook for 2025, which we have shared earlier today and in this presentation by Jon. Regarding the 2027 vision, we continue progressing in all four areas and remain on track to meet our target of revenue, U.S. commercialization, pipeline progress, and operating margin. With this, as a final note, I hand over the call to our operator for Q&A.
Thanks. And our first question comes from the line of Viktor Sundberg from Nordea. Please go ahead.
Yes, hi. And thanks for taking my questions. So I had one on your guidance. You gave quite much color on the cost side, but I just wanted to get some more detail on the total revenue guide. So looking at Buvidal and the specific markets that you see accelerating the growth here in 2025, you previously talked about Germany and the challenges with reimbursement for long-acting. So I just wonder if there's any update here or in other key geographies. Also on polycystic liver disease for CAM2029, it looks quite a risky study given the data that we have seen on Sandostatin LAR. But I just wondered what the next steps would be if the study would read out well here in Q1. Could that be registrational, or do you need a phase III, and how would that look like in terms of size, control arm, etc.?
And just finally, I just wondered also around your M&A strategy. You've been quite forward that you look for M&A opportunities. So any comment if that is still the case, and what kind of assets you think could fit within your company at this stage? Thank you.
Thank you, Viktor. I mean, on the first question, I think we continue to see a lot of the drive in the large European countries, as Richard said earlier. And that includes, of course, Germany, the U.K., but also more increasingly, we see progress in Spain and also France and other countries. So that's, I think, our focus area from a geographical perspective. Richard, any more?
No, nothing that comes up.
When it comes to the polycystic liver disease, of course, that is a very interesting study for us, and this is an indication where there's currently no treatment, so I think you should regard this, as we have said, a phase II/III study. In the U.S., we do not believe it will suffice with one study. There's a potential in Europe, but our idea is to, based on the data from the phase II trial from Positano, we should formulate the phase III trial, which we are currently planning, and we cannot say anything about the details here. We have been working on it for quite some time now and planning the design and also the timelines for the study.
And I think we have a really good starting point here, but we need the data before we can finalize this and come up with the powering of the trial and so forth. But so far, we have done a lot of work, and I think overall looks interesting. So any follow-up questions on that, Viktor, before we move on?
M&A strategy.
Oh, yes, sorry. Yeah. I mean, the M&A strategy remains as previously communicated. We are chiefly targeting commercial assets or pre-commercial assets, which are synergistic to our current pipeline or commercial organizations in the different territories where we operate. Viktor, any?
Thank you. I jump back into the queue. Thank you.
Thank you.
[Operator's Instructions] The next question is from Christopher Uhde from SEB. Please go ahead. Your line is open.
Hi there, Christopher Uhde from SEB. Thanks for taking my questions. I guess the first one is on the regulatory situation. Just if there's any more clarity you could possibly give us insight into the reasons for the OAI classification, and is the establishment inspection report all that you need to be able to refile, or what else might be necessary? And what if they say there are still deficiencies? What happens then?
Yeah, that's a very good question. I mean, overall, just to go back, we were expecting to get the classification, of course, as I said, much earlier, so in mid-December and so forth. It's been quite a, yeah, it's an interesting dynamic right now at the agency, if I put it that way. However, I think we have a clear. We know, of course, what the 483s are or how a manufacturer does, and they were quite satisfied with the state of those being addressed. We are not completely clear on the review history, and that's why we need the EIR, because we need to get clarity on whether or not there are any of the questions that are outstanding. We suppose so. And if so, what the actions we believe are necessary.
I think that, I mean, having studied the 483s, there is nothing that seems to be, from a time perspective, very extensive in mitigating. So I think that we are in a good shape there, but we simply need the EIR to be able to better clarify whether or not we have resolved everything or if there is anything left to address by the manufacturer. On the positive note, we don't have anything, of course, with regards to the product. The product, we had no objections and really no comments on. We were ready with labeling, so we should be able to move very quickly in terms of refiling.
Okay. And then if I could ask another question around the guidance. I guess in light of this, fair to assume that you're assuming an immaterial contribution from Oczyesa in 2025. And then how about Brixadi? Because last year, you had sort of indicated indirectly that the guide from your partner was extremely conservative. If we try to back that out for this year, what are you expecting for Buvidal's growth in 2025?
No, I think that, I mean, starting with the first question, you can regard Oczyesa to be quite immaterial in terms of its contribution. When it comes to, I'm not really sure about the comment you made there regarding the partner, but I think that overall, they probably have quite realistic views. I cannot comment their views, and therefore, I don't want to split the two components. So I think that you can regard a majority or a very large part of our guidance to be constituted in terms of revenue of the two Buvidal and Brixadi, but we are not providing them separately at this point.
Fair enough. In terms of, I mean, you had 4,000 patients added this last quarter. Is that the new floor?
We don't have a floor. I mean, we have a target, and we are tracking towards the target, which is the 100,000 patients in 2027. We don't have a floor. I think it will vary by quarter, so we are not foreseeing that we will have a constant or have a floor. It will be varying by quarter as we have seen previously, and I think that's, yeah, but our target remains.
Yep. If I could just ask a couple more questions around the specific markets. And I apologize. I had trouble hearing the answer on the reimbursement in Germany. But let's say, starting with that and so the reform, what factors will determine the timing of that, and who or which body decides? And do you have any insight into, yeah, the reasons around that timing?
We know the process, but because we are a commercial company, we have to have a completely hands-off approach here. So we are just following this from the sidelines. We understand that there is among the different parties that are involved, which is the kind of insurance providers. It is, of course, the medical community as well as the political dimension. What we have understood is that there is a consensus that they need to change the current remuneration basis, and we think that would be very good in terms of providing German patients with a much better treatment option, better treatment options.
We understand from the latest updates that there are still expectations that this will be finalized in 2025. However, all of these processes are externally driven, but I think there is a positive view on that and positive development.
Got it. And then I guess, so if we talk about England, France, Germany, and Spain, which is performing relatively best versus your expectations at the start of 2024, and which the worst? And what gating events in those markets might be required, reimbursement aside, to occur in order to deliver on your guidance?
Christopher, I don't think, I mean, I think in terms of performance, I think we have seen very strong performances across markets. So we're pleased with all of these markets that I mentioned. And actually, I mean, we're seeing consistent growth. There might be one or two markets that are having a slower pace this quarter, but overall, very good performances. So we are pleased with that. And we are also pleased with the fact that we are now able to go in and launch the products in three more countries.
And we have processes ongoing in other countries as well. So we look forward to the market expansion possibility that has come up now, both in Portugal and Switzerland. I mean, Luxembourg is a very small country, but still, they have 1,000 patients there approximately. So that's a very important part and market expansion process will continue here going forward. I can't comment on specific countries.
Yep. That's all from me. Thank you.
Thank you so much.
The next question from Oscar Haffen Lamm at Bryan Garnier . Please go ahead.
Hi team. I'm also here from BG. Thank you for taking my question, so on Buvidal, I was wondering if you could provide some granularity on what % market share you have in major European markets, and if you believe that the uptake in patients added on treatment this quarter will be maintained in the coming year, taking into account the new markets that are to be included. And then my second question would be on the Obesity Trial, and more precisely, after how many weeks on treatment will you measure the weight loss? And then as a follow-up on that, what would be your estimated threshold for efficacy that would convince you to push the program forward? Thank you.
Yeah, thank you. I mean, when it comes to the European markets, I think they vary from very high percentages to lower. But maybe, Richard, you can give a comment on the broad.
Yes. I mean, we shared Australia, obviously, before, and that one's there, and as Fredrik said, there's a range. Sometimes it depends, of course, if those markets are high Buprenorphine markets or high methadone, but we're making advance of the methadone. So yeah, I mean, there's a range from up to 30% in some markets and in high single digits in others.
I think generally speaking, we can say that in the larger countries, we are around in the low double-digit range or high single-digit range, whereas in the Nordic markets, for instance, we are up to 35%, even up to 60%-70% in Finland, as we have said before.
Oskar, sorry. It's Jon. Just to check one aspect. The answer relates to general market shares. Your question was specific to prisons or to general market shares?
To general market shares, yeah.
Okay. Thank you. And then the second one was GLP-1, Fredrik.
Yeah. In terms of the GLP-1 study, we are conducting that based on the toxicology work that we had done before. Currently, for the CAM2056 groups, it's a 12-week period that we are studying. And of course, that includes any dose titration that you might be expecting. In terms of the weight loss thresholds, we have not. This is a study looking at pharmacokinetics, tolerability, and weight loss. It's, of course, not one isolated topic we are looking at. We are looking at the complete holistic outcomes of the study. I wouldn't comment on the exact threshold because it's still an early study. But certainly, we are expecting to see data that will point us in the direction and that we will be able to use for our forthcoming larger trials. I'm not concerned about that at all.
I think we will be able to read out the results. And we have a study population of overweight and obese patients. So we will see, we'll get a good picture of the efficacy also on that note.
Okay. Super helpful. Thank you. And maybe just one additional question. For Brixadi in the U.S., since we're on the topic of the prison system, I mean, considering the large portion of patients that are in the prison system that would be eligible for treatment, I was wondering if at this stage, you're already able to give a percentage of patients currently on Brixadi that are coming from this system and how you view this segment moving forward this 2025 and onwards?
I can say that the opportunity is, of course, very significant. We're talking about a large number of patients. It varies by the states because, I mean, in some states, there is an established treatment system in place, whereas other states do not have it, and that's very much geographically dependent, but overall, the opportunity is very large, and obviously, Brixadi has only been in the market for just over a year, so this opportunity is, as I said, largely untouched in terms of penetration by Brixadi, as you might imagine.
Yeah, that makes sense. Makes sense. That's all from me for now. Thank you for taking my questions.
The next question from Mattias Häggblom from Handelsbanken. Please go ahead.
Thank you so much, Mattias Häggblom from Handelsbanken. Two questions, please. Regarding the 2027 targets of SEK 4.5 billion in revenues, historically, SEK 3 billion was expected to be derived from Buvidal Brixadi and SEK 1.5 billion from CAM2029. With the CRL for acromegaly, but perhaps more importantly, in light of the market size for GEP-NET, the longer accrual time of events in Sorrento, with a submission, as I understand it, targeted for second half 2026. I'm curious to hear if you still expect the SEK 1.5 billion contribution from CAM2029 by 2027, or is it fair to say that you perhaps expect a larger contribution from Buvidal and Brixadi today compared to those initial projections back in 2022 at the R&D day? And then I have a follow-up.
Yeah. So I'm not completely sure of your starting point here because at the R&D Day, we talked about. I think you're referring mainly to the contribution from Buvidal there in your initial number. And then the rest was a mixture. So no, we don't see, obviously. I mean, the acromegaly indication was and remains a small but important indication for us in terms of the CAM2029 franchise. And we still have a component coming in from CAM2029 into our 2027 estimates. I don't think we have commented on the size of that, Jon. Have we? No. But we remain, as we say, we remain on track to reach the target. And that's a mix of the different indications I referred to or the different products I referred to. But of course, the largest contribution comes from Brixadi and Buvidal. No discussion about that.
Okay. There's a slide saying Buvidal bound for penetration, SEK 3 billion, and late-stage product candidates, SEK 1.5 billion. So maybe the SEK 1.5 billion included Brixadi.
Yes, exactly. That's completely correct. Yeah. That's correct.
Okay. Because I recall another peak sales potential of Buvidal in euros, but maybe historically provided. Correct me if I'm wrong. I thought it was 170 million EUR, something like that.
I don't know.
At that point in time.
I don't know where that number comes from, but anyway.
Okay. All right. The target is reconfirmed no matter what. Okay. Then secondly, looking at the FDA Orange Book, there are eight patents listed protecting Brixadi, the longest to July 2032. So once CAM2029 is approved, are there patents beyond July 2032 that we should expect to be listed in the Orange Book for that product, or are timelines broadly the same? I know you have received orphan drug designation for PLD from the FDA, but I'm not aware of such protection for GEP-NET, for instance, in the US market. So any clarification for IP would be helpful.
Absolutely. So I mean, in terms of CAM2029, we have IP covering at least up to 2037. So I mean, there is different IP to that that covers Buvidal, of course, and potentially for longer time periods over time. So we do have a number of filings that extend beyond the Buvidal timeframe.
That's very helpful. Thanks so much. That's all for me.
Thank you, Mattias. Thank you.
The next question is from Viktor Sundberg from Nordea. Please go ahead, Viktor. Viktor, please go ahead.
Yeah. Sorry, I was on mute. Yes. I just had a follow-up on the Sorrento trial also. It seems like you have twice monthly dosing in that trial. Is that a way to boost your arm versus the control arm that's given once monthly? Do you expect higher bioavailability of the active compound? And with that, so to speak, the risk to read out of this trial, since it seems that retrospectively, it is the higher bioavailability and its correlation to progression-free survival that seem to drive your optimism around this trial. Any comment here would be helpful. Thank you.
Yeah, it's correct. I mean, the higher bioavailability is definitely consistent also in the NET indication. So in fact, the AUC, the area under the curve, so the total exposure of the treatment period is roughly about seven times higher for CAM 2029 at the dosages given in the NET trial compared to the reference product. And then I have to, of course, refer to the octreotide reference product because in the trial, you have both the octreotide and the lanreotide products. But here, I'm referring to the octreotide. Was that an answer?
With regards to lanreotide, any difference there you expect from the smaller trials that's been done, or are they quite similar in your opinion in terms of?
I mean, if you ask the clinical community, they will tell you that they are quite similar. There are some studies. They are all small. They are indicating in some cases that the octreotide arm provides better control, and in some cases, actually the opposite. So I think we are trying to rely on the basic material that we have internally. But there is no good comparative data for lanreotide or octreotide, I would say, not in a large randomized prospective trial.
Okay. That's very helpful. Thank you.
Thank you.
The next question is from Patrik Ling from DNB Markets. Please go ahead, Patrick.
Thank you. Two short questions, actually. First of all, when it comes to your M&A strategy, you talked about commercial and pre-commercial assets that you're looking at. Could you elaborate a little bit on how pre-commercial you're actually looking? Are we talking late stage, phase III, or maybe phase II trials?
Yeah. I mean, basically, late stage is our target. However, if there are certain reasons for looking at both the technology we are possessing, so to speak, and also our kind of key interests, we could, in some cases, also look at phase two assets. So we are not bound by any, but our clear preference and focus is on commercial stage or late stage. So I think that's my answer, our answer.
Okay. Good. And then how far from where you are today on sort of the different indications would you be willing to look at assets?
We are looking at this from a scientific and commercial standpoint. Basically, we can operate within rare disease, but our preference is for endocrinology assets, some niche oncology we have talked about, and CNS. That's the topics that we have most interest in. But naturally, you have to look broadly to find the most interesting targets.
Okay. Great. Then my last question is really about your new manufacturing facility that you're going to invest in. If you could elaborate a little bit on, is it Europe? Is it US? Is it for existing products or new products? Can you give us a little bit on what you're going to do?
Yeah. Yeah. When we did, I mean, when we did our capital raise, we mentioned that also in our use of proceeds. But I would like to say that our focus is on building out our capacity, and especially then thinking about what is happening. We are targeting to build out the U.S. manufacturing capacity. So that's and create that. We are not manufacturing ourselves, but that's one of the main aims. So that is the process that we have had ongoing and a focus we have had ongoing for the past at least 12 months or so to give us flexibility. And we also have new programs entering clinical phase, and those, of course, also need clinical manufacturing resources. So that's the target.
Okay. Great.
Yeah.
Good. Thank you. That's all for me.
The next question is from Dan Akschuti from Pareto Securities. Please go ahead, Dan.
Hello, and thank you for taking my questions. I think most has been answered. Just one question on CAM2056, how the enrollment has been going, if that is according to your expectations, and if you're seeing any competition with competitors? And if so, do you see any, I mean, competition for patients? And if so, do you see any promising competitors aiming also for monthly or longer depots? Thank you.
I mean, essentially, this is a phase one trial, although we have then characteristics of overweight and obesity included, but they are otherwise healthy volunteers. I think we have had no problem in terms of recruitment. So that's progressing well. And of course, it's the first study. So we are looking at the competitive side. I mean, obviously, there are so many programs going on in this space of various nature and so forth. So I'm certainly aware of competitors in different ways or forms and shapes. But in terms of monthly dosing in the clinical setting, there is very little there. I mean, Amgen has a program that you perhaps, but that's a different approach. And there has also been an announcement regarding Ascendis. But I think that's the earlier stage.
Okay. Thank you very much.
The next question is from Erik Hultgård from Carnegie. Please go ahead, Erik.
Yes. Hi. I have a question, I guess, for Richard. If you could comment on the average price, how that has changed over the course of 2024, and what you see in terms of pricing in 2025 in your major geographies. Is there any price cuts in certain markets that you have baked into the guidance? Thank you.
No. The pricing has been flat for the last couple of years, and we predict it remaining so coming forward.
All right. Thank you.
There are no more questions at this time. So I hand the word back to you, Fredrik, Jon, and Richard for some closing comments.
Yes. Thank you, everybody, for a very good Q&A session. I think it's been a very good year for us, and I'm happy that we have a lot of questions coming up from it. So Jon, do you have anything? Last comments, Richard?
Thank you, everyone. I'm looking forward for Q1 next year.
Yeah. We have Q1 coming up, but in May. So thank you, everybody, and have a great afternoon.