Camurus AB
STO:CAMX
Camurus AB
Camurus AB is a Swedish pharmaceutical company that stands out in the industry with its innovative approach to treating chronic and rare diseases. Rooted in its proprietary FluidCrystal® injection depot technology, Camurus integrates this platform into the development of long-acting medications that aim to improve patient compliance and outcomes. This lipid-based system allows for the extended release of active substances, providing sustained therapeutic effects from just a single dose. Founded in 1991, the company has strategically focused its efforts on areas often underserved by traditional pharmaceutical giants, such as addiction, pain management, and endocrine disorders. By concentrating on these specific therapeutic areas, Camurus not only addresses significant health challenges but also carves out a niche with limited competition, potentially leading to substantial revenue streams.
The company generates its income predominantly through product sales and strategic partnerships. One of its flagship products is Buvidal®, a long-acting medication for the treatment of opioid dependence, which has made significant inroads across Europe and Australia. The sustained revenue from Buvidal® highlights the company's adeptness at capitalizing on its technology to create tangible healthcare solutions. Additionally, Camurus engages in licensing agreements and collaborations with international pharmaceutical firms, expanding its market reach and leveraging its technology across a broader canvas. By investing heavily in research and development, Camurus ensures its pipeline continues to be robust, with new products consistently in various stages of clinical trials, thereby securing its financial performance and position in the pharmaceutical industry.
Earnings Calls
In a promising fourth quarter, Camurus achieved SEK 553 million in revenue, a remarkable 48% increase year-over-year, with a strong performance from both Buvidal and Brixadi. The company is targeting total revenues of SEK 2.7 to 3 billion for 2025, reflecting a 45% to 61% growth, alongside expected profits before tax of SEK 0.9 to 1.2 billion. Despite setbacks with CAM2029's regulatory review, Camurus aims for significant revenue growth driven by their expanding U.S. operations and ongoing clinical trials. They remain confident in their long-term vision to quintuple revenues by 2027 while achieving a 50% operating margin.
You don't have any saved screeners yet
Welcome to Camurus Q4 Report 2024. [Operator Instructions] Now I will hand the conference over to CEO, Fred 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 5-year vision of fivefold 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 Oclaiz in acromegaly. On the development side, regulatory reviews of CAM2029 continued in the U.S. and 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, Sorento and Positano continue to advance. And 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.
And 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 a 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 459 million, growing 28% versus prior year and 11% versus prior quarter.
Additionally, Brixadi sales in United States represented an SEK 83 million royalty income, growing 43% versus prior quarter. Looking at full year results, Camurus reached SEK 1,858 million total revenue, representing a growth of 9% versus prior year. Excluding onetime 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 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 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 3 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 incentive 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 onetime expenses of SEK 8 million regarding advisory fees that are reported in other operating expense line. Company profit before taxes reached SEK 186 million, growing SEK 204 million versus Q4 '23.
On a full year basis, company profit before taxes reached SEK 553 million, which excluding one-time milestone revenue impact, represents an improvement by SEK 409 million, increasing 286% versus 2023. Company cash position at quarter end was SEK 2.85 billion. Camurus improved its cash position by SEK 101 million during the quarter, driven by following 4 factors: firstly, company operations generated SEK 156 million. Secondly, sale window of ESOP ‘21/'24 program generated SEK 18 million. Thirdly, working capital consumed SEK 63 million, and fourthly, investing activities required SEK 20 million. At the end of quarter, Camurus has no debt.
Moving now to 2025 guidance. 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, an incremental investment of approximately SEK 0.35 billion to fully deploy U.S. operation, launch globally and support company growth. Social security costs regarding company long-term safety programs will vary with the share evolution. And from a capital expenditure point of view, company will invest about SEK 0.2 billion in the next 2 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 billion to SEK 3 billion, representing a growth of 45% to 61%, profit before tax in the range of SEK 0.9 billion to SEK 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. So, 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 previous year. And at the end of the year, we estimated that 60,000 patients were currently being treated with Buvidal. In the EU, this was led by the large European markets with 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 and clinics. Our market expansion continued. And in the quarter, we had 3 new reimbursement approvals that were received in Switzerland, Portugal and Luxembourg, and will launch Buvidal in early 2025 in those countries. Additionally, 4 other regulatory applications are under review.
Now moving across the U.S. Firstly, a reminder of the U.S. market where there are an estimated 6 million to 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 had 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 are transfers from other long-acting products and direct initiations into treatment from Brixadi -- 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 3 important publications. First was an exploration of treatment outcomes by quantitative urine measures that emphasized treatment effects 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 explores 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 the leading congresses. And on that note, I'll hand back to Fredrik for an R&D update.
Okay. Thank you. I would start with CAM2029 and the developments across the 3 target indications, acromegaly, gastroenteropancreatic neuroendocrine tumors and polycystic liver disease, PLD. In acromegaly, the 2 ACROINNOVA Phase III trials have been successfully completed with positive results. The last 2 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-controlled SORENTO 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 2 or 3 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 or we look forward to an FDA approval on the PDUFA date of 21st of 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 safety efficacy, or chemistry manufacturing and controls. The manufacturer has responded to the observation 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 the CHMP opinion around midyear 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 results of the ACROINNOVA-1 trial were 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.Â
Our medical and MSL teams have been very active in 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 preparing 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 be above USD 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, and 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 2 dosing schedules of CAM2056 against the dose titration to label schedule, which exists 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, and neuropsychiatry and are of keen interest to cameras for the potential treatment of substance use disorder.Â
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. And we have built here a state-of-the-art lab tailored to our different needs from early to late-stage development. And 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 contribute 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 4 areas and remain on track to meet our target of revenue, U.S. commercialization, pipeline progress, and operating margin.
So, with this, as a final note, I hand over the call to our operator for Q&A.
And our first question comes from the line of Viktor Sundberg from Nordea.
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, are there any 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, polycystic liver disease for CAM2029, it looks like 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, et cetera? 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, 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. So 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 detail?
No. I think I covered it.
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 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 time lines 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.Â
_
Yes, sorry. 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.
[Operator Instructions] The next question is from Christopher Uhde from SEB.
I guess the first one is on the regulatory situation. Just if there's any more clarity you could possibly give? So, 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 there?
Yes, 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 -- 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 manufacture 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 483, 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 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 no -- really no comments. So, we were ready with labeling. So, we should be able to move very quickly in terms of refiling.
And then if I could ask another question around the guidance. I guess in light of this, it's fair to assume that you're assuming an immaterial contribution from Oclaiz 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 growth in 2025?
I mean, starting with the first question, you can regard Oclaiz 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 2 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 2, 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 -- 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 -- yes, but our target remains.
If I could just ask a couple more questions around the specific markets, and I apologize, I had trouble hearing the answer on the remuneration 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, yes, 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, 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 for -- in terms of providing German patients with a much better treatment option, better treatment options. We understand from the latest updates that there is 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. 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 is the worst? And what gating events in those markets might be required remuneration aside to occur in order to deliver on your guidance?
Christopher, I don't think -- I mean, 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 1 or 2 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 3 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 we will -- that market expansion process will continue here going forward. But I can't comment on specific countries.
The next question from Oscar Haffen Lamm from Bryan Garnier.
So on Buvidal, I was wondering if you could provide some granularity on what percent market share you have in major European markets. And if you believe that the uptick 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?
Yes. Thank you. I mean, when it comes to the European market, 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 there. And as Fredrik said, there's a range. Sometimes it depends, of course, those markets are high buprenorphine markets or high methadone, but we're making advance of the methadone. So yes, 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 that we have said before.
Oscar, sorry, this is Jon. Just to say one aspect. The answer relates to general market shares. Your question was specific to Brixadi or to general market shares?
To general market shares, yes.
And then the second one was GLP-1.
Yes. So, in terms of the GLP-1 study, we are conducting that based on the toxicology work that we had done before. So currently, it's for the CAM2029 -- 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. So, it's, of course, not one isolated topic we are looking at. We are looking at the complete holistic outcomes of the study. So, I wouldn't comment on the exact threshold because it's still an early study. But certainly, we're expecting to see data that will point us in the direction and that we will be able to use for our forthcoming larger trials. So, I'm not concerned about that at all. I think we will have -- 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. And maybe just one additional question, for Brixadi in the U.S. Since we're on topic of the prison system, I mean, considering the large portion of patients that are in the prison system, there would be a little of 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 consists -- is very large. And obviously, Brixadi has only been in the market for just over a year. So, this opportunity is, I said, largely untouched in terms of penetration by Brixadi as you might imagine.
The next question from Mattias Haggblom from Handelsbanken.
Two questions, please. So, regarding the 2027 targets of SEK 4.5 billion in revenues. So historically, SEK 3 billion was expected to be derived from Buvidal and Brixadi and SEK 1.5 billion from CAM2029. With the CRL for acromegaly, but perhaps more importantly, in light of the market size for GapNet, the longer accrual time of events in SORENTO with a submission, as I understand, the targeted for second half '26. I'm curious to hear if you still expect the SEK 1.5 billion contribution from CAM2029 by '27? 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.
Yes. 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 -- 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 going to penetration of 3 billion and late-stage product candidates, 1.5 billion. So maybe the 1.5 billion included Brixadi?
Yes, exactly. That's completely true.
Okay. Because I recall that another peak sales potential of Buvidal in euros, but maybe historically provided. Correct me if I'm wrong, I thought it was EUR 170 million, something like that. At some point there?
I don't know where that number comes from, but anyway.
Okay. All right. The target is reconfirmed no matter what. Okay. And then secondly, looking at the FDA Orange Book, there are eight patents listed protecting Brixadi, longest to July 2022. So once CAM2029 is approved, are there patents beyond July 2022 that we should expect to be listed in the Orange Book for that product? Or are time lines broadly the same? I know you have received often drug designation for PSD from the FDA, but I'm not aware of such protection for instance, in the U.S. market. So, any clarification for long-term IP would be helpful.
Yes. Absolutely. So, I mean, in terms of CAM2029, we have IP covering at least up to 2037. 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 time frame.
The next question is from Viktor Sundberg from Nordea.
I just wanted to add a follow-up on the SORENTO 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, there is the readout of this trial since it seems that retrospectively, it is the higher bioavailability and this correlation to progression-free survival that seem to drive your optimism around this trial. Any comment here would be helpful.
Yes, it's correct. I mean, the higher bioavailability is definitely consistent also in the NET indication. So, in fact, the AUC, the area on the curve, so the total exposure of the treatment period is roughly about 7x higher for CAM2029 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 lanreotide products, but here, I'm referring to the octreotide.
And lanreotide, any difference there you expect from the smaller trials that has been done? Or are they quite similar in your opinion in terms of efficacy?
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.
The next question is from Patrik Ling from DNB Markets.
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?
I mean, basically, late stage is our target. However, if there are certain reasons for and looking at both the technology we are possessing, so to speak, and also our kind of key interest, we could, in some cases, also look at Phase II 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. Then how far from where you are today on sort of the different indications, would you be willing to look at assets?
Well, we are looking at it 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 topic 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 U.S.? Is it for existing products or new products? Can you give us a little bit more flavor on it?
Yes. 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. 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.
The next question from Dan Akschuti from Pareto Securities.
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 competition for patients? And if so, do you see any promising competitors aiming also for monthly or longer depots?
Well, essentially, this is a Phase I trial, although we have then characteristics of overweight and obesity is included, but they are otherwise healthy volunteers. I think we've had no problem in terms of recruitment. So that's progressing well. And of course, it's the first study. So, we are exploring. Looking at the competitive side, 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 but that's a different approach. And there has also been an announcement regarding Ascendis. But I think that's early stage.
The next question is from Erik Hultgård from Carnegie.
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?
No. The pricing is flat, has been flat for the last couple of years, and we predict it remaining so going forward.
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.
Yes. We have Q1 coming up, but in May. So, thank you, everybody, and have a great afternoon.
The host has ended this call. Goodbye.