Total revenue in 2023 to a total of SEK 480 million. Profit before tax increased by 125% to SEK 165 million in Q3. Our best result so far, again, excluding the one-time milestone. Based on the performance and results year to date, we have raised our outlook for the full year 2024, particularly as regards to profit performance, and our cash position at the end of the quarter increased to SEK 2.75 billion, again with no debt in the company. We continued focusing on commercial execution, with overall sales growing nicely by 22% year on year to SEK 421 million in the quarter. In the U.S., Brixadi net sales increased by 39% year on year, or quarter on quarter, I should say, sorry about that, resulting in a royalty contribution of SEK 58 million to Camurus. Our R&D pipeline advanced with positive phase three results from our ACRINOVA study.
Our U.S. NDA progressed to labeling. However, after the quarter, we received a CRL from the FDA regarding a CGMP inspection at the third-party manufacturer, which is currently pending classification, and we expect to get clarity about this early December. In parallel with the U.S. NDA process, the regulatory MAA review moved forward in the E.U. Additionally, preparations for the first clinical study of monthly semaglutide depot CAM2056 were completed. Based on the strong performance year to date, Camurus remains on track to deliver its 2027 vision, and with this, I'll leave the word over to Jon for a financial review.
Thanks a lot, Fredrik, and good afternoon, everyone. During the quarter, Camurus continued its development, delivering a strong financial performance, and I would like to share now the key highlights of this quarter. At the end of the quarter, Camurus achieved SEK 480 million total revenue, compared to SEK 384 million in the same period prior year. Excluding SEK 36 million one-time milestone revenues related to Brixadi approval by the FDA in the U.S. in 2023, company revenues grew by SEK 132 million, delivering a growth of 38% versus the same period last year, which is in the high range of provided guidance for this year. Buvidal sales reached SEK 421 million, growing 22% versus the prior year and 5% versus the prior quarter. Swedish Kronor appreciation has impacted negatively reported figures by two points year on year basis and four points versus the prior quarter.
Brixadi sales in the US represented a 58 million SEK royalty income in the quarter, representing a 45 million SEK improvement versus the prior quarter. Company profit before taxes was 165 million SEK, achieving an earnings per share after dilution of 2.16 Kronor, equivalent to a profit after tax of 129 million SEK in the quarter. Finally, our cash position progressed positively during the quarter and remains strong, ending at 2.75 billion SEK. Moving to the next slide, we can see the main components of our profit before taxes. Company gross margin reached 93% in the quarter. Excluding one-time milestone revenue impact, it represents an improvement of 222 basis points versus the same period prior year, driven by three major factors. Firstly, supply chain efficiencies driven by Buvidal volumes scale-up represented 163 basis points. Secondly, 100 basis points are driven by Brixadi royalty.
Thirdly, FX represented a negative impact of 41 basis points. Total OPEX reached SEK 304 million, representing a 21% increase versus the same period prior year, driven by the following factors: marketing and distribution investment to support market penetration in own territories, expansion of Buvidal into new markets and U.S. operations grew 19% to SEK 112 million. Administrative expenses aligned with corporate evolution to substantiate company development grew 155% versus the same period last year to SEK 27 million. R&D investment reached SEK 163 million, growing 10% versus the same period prior year, driven by progress in our preclinical and clinical pipeline. Operating profit before taxes reached SEK 165 million. Excluding one-time milestone revenue impact, it represents an improvement by SEK 92 million, increasing 125% versus the same period prior year. Company cash position at quarter-end was SEK 2.75 billion.
Camurus improved its cash position by SEK 184 million in the quarter, driven by the following four factors. Firstly, company operations generated SEK 134 million. Secondly, working capital generated SEK 16 million, driven by account receivables reduction mainly. Thirdly, financing activities driven by the exercise of the stock option program delivered SEK 45 million cash. And finally, company invested SEK 6 million in technological activities. At end of quarter, Camurus has no debt. All in all, Camurus closes third quarter with a strong operational performance and solid financial position. As a consequence of such strong performance year to date, versus the expectations.
Camurus outlook for total revenue was increased to the range of SEK 1,810 million-SEK 1,880 million, from a prior range of SEK 1,730 million-SEK 1,840 million, with profit before taxes estimated in the updated range of SEK 450 million-SEK 510 million, from a prior range of SEK 330 million-SEK 450 million, and is on track to deliver the long-range plan vision shared at Capital Market Day, celebrated in September 2022. Having said that, I would like to pass the word to Richard. Thank you, everyone, for your attention.
Thank you, Jon. I'll start with an update on the Camurus markets and then move to Brixadi in the U.S. In Camurus markets, the third quarter saw further development of Buvidal, reaching SEK 421 million, 24% year-on-year growth at constant exchange rate, and 6% ahead of the previous quarter. We estimate there are 56,000 patients on treatment at the end of the quarter, a net increase of about 3,000 patients. Growth was seen across our markets, in particular Germany and the U.K., which saw good progress as we continue to implement new initiatives to accelerate patient recruitment. Other markets were slightly softer due to the holiday season restricting patient recruitment, though, as expected, picked up at the end of the quarter as staff returned to work. In all countries, penetration is growing in both custodial and community settings.
In Australia, the new distribution and payment system following the recent government changes was fully implemented. This is a positive change as patients have reduced out-of-pocket costs for administration, and we're now focusing on addressing bottlenecks for patient recruitment by expanding pharmacy administration and increasing engagement with primary care physicians. We continue to address reimbursement hurdles in new markets and expect at least two of these to be finalized in Q4, with launches soon after in early 2025. In addition, we have four markets undergoing regulatory reviews with anticipated outcomes in 2025. In 2023, we made a donation to support patients in the Ukraine during the conflict and have now received a positive assessment of this experience and how Buvidal has supported patients during the time. We're now exploring ways to continue to support patients in the country.
Now, moving across the U.S., Q3 continued the sales development of Brixadi, demonstrated by the increasing royalty to 58 million SEK, a growth of 39% at constant exchange rate compared to the previous quarter. The increasing market share comes primarily from the capture of patients from sublingual buprenorphine products and the remainder transferred from other long-acting injectable products or being direct initiations. As we've communicated before, the opportunity in the U.S. is significant, with an estimated more than six million people with an OUD diagnosis and an estimated 1.8 million treated with sublingual buprenorphine. The peak market potential for Brixadi is significantly above $1 billion, which only represents 6% market penetration of existing treated patients.
Finally, we continue to be very active in congresses and scientific meetings to share the evidence base for Buvidal and have a full schedule of key meetings for the rest of this year and in 2025. Additionally, we have further publications from across geographies as we expand the evidence base for Buvidal and Brixadi in both community and custodial settings, and on that brief update, I will hand back to Fredrik.
Thank you so much, and over to an update on our core R&D programs. During the second quarter, we advanced our late-stage clinical development programs of octreotide subcutaneous depot, CAM2029, across three target indications of acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease. Starting with acromegaly and the ACRINOVA program, in July, we received positive phase 3 results from a 52-week open-label ACRINOVA study evaluating safety and efficacy of CAM2029 in newly enrolled patients and rollover patients from ACRINOVA I. Key findings and observations in this study included a safety profile consistent with that of current standard of care with first-generation somatostatin receptor ligand products, increased biochemical response rates in the overall population after 52 weeks of treatment with CAM2029, again compared to standard of care at baseline.
Consistent with Acrinova I, we also saw improvements in symptom treatment satisfaction and quality of life scores versus standard of care at baseline. Now, recently, the main results from Acrinova I have been accepted for publication in the Journal of Clinical Endocrinology and Metabolism, and after that, we'll see them published very soon or already, and after that, we'll move over to the GEP-NET program. I intend to share an update on the progress of the pivotal phase three Sorrento study. As a reminder, Sorrento is the largest prospective randomized control trial of a somatostatin receptor ligand in gastroenteropancreatic neuroendocrine tumors. The study is designed to assess superiority in progression-free survival of CAM2029 compared to investigators' choice of standard of care with octreotide LAR or lanreotide Autogel.
A broad population of GEP-NET patients with advanced metastatic inoperable, well-differentiated neuroendocrine tumors of grade one to three have been included in this study. The trial is powered to a hazard ratio of 0.65, and the primary results will be assessed after 194 PFS events, progression-free survival events. Secondary outcomes include overall survival, multiple patient-reported outcomes, and, of course, safety. SORRENTO is a global study with a geographic distribution of patients as seen in this slide. All in all, we included 332 patients across 12 countries, which is 10% above our target recruitment due to high interest and rapid inclusion. Having reached an average treatment time of 15 months in the study, we recently performed an updated analysis of the number of tumor progression events or deaths in the trial.
This was done to guide the expected timing for reaching the target number of PFS events for reading out the primary endpoint. The analysis points to longer-than-expected PFS for the patient population in the Sorrento trial, of which a majority had more advanced disease with grade 2 neuroendocrine tumors. The rest were grade 1, and a few were grade 3 disease patients. Based on better-than-expected tumor control in the study, the estimated timing for reaching the target number of PFS events has been updated from the first half of 2025 to late 2025 or early 2026. The next external update on Sorrento is planned for Q1 2025. Moving over to polycystic liver disease and the Positano study. Positano is a 52-week randomized controlled trial assessing efficacy and safety of CAM2029 in two-dose groups versus placebo.
The primary endpoint is height-adjusted liver volume, and secondary endpoints include PLD symptoms measured using a newly developed patient-reported outcomes tool, total cyst volume, treatment satisfaction, quality of life, and safety. Patients who complete the randomized phase have the option to enter a long-term extension, which has been prolonged to 32 months of open-label treatment. Moving to the next slide. A total of 71 patients with symptomatic PLD have been included in POSITANO. The last patient entered into the study in February this year. More than half have completed the randomized treatment phase and switched over to the open-label extension. Top-line results of the core randomized phase of the study are expected in the first half of 2025.
Aside from clinical progress during the quarter, we also received a recommendation for orphan drug designation for CAM2029 in autosomal dominant polycystic liver disease from the EMA, which now has been formally adopted by the European Commission. So, as a summary, here is the updated timeline for our three pivotal clinical programs for CAM2029. Moving over to regulatory and an update in acromegaly. As you're aware, we received a CRL from FDA on the 21st of October. That is a complete response letter. After having had late ongoing labeling discussions with the agency, the CRL was solely related to observations during a CGMP inspection at a third-party manufacturing facility and did not raise any concerns relating to CAM2029, including safety or efficacy, or for that matter, quality. Unfortunately, the timing of the inspection precluded resolution of the observations by the PDUFA date.
Since the inspection, the manufacturing has answered all the observations and is expecting a classification by early December. Providing this is satisfactorily addressing the agency's observations, Camurus will rapidly resubmit the NDA for review. We are working towards a scenario of class one resubmission with an anticipated two-month review period. Otherwise, a six-month timeline would be applicable. Finishing off with some early R&D developments, we have completed preparations of a randomized dose-escalating multiple-dose phase one study of monthly semaglutide in overweight and obese participants and are expecting a first subject first visit early in the next year. Preclinical assessments of other long-acting GLP-1 agonists have also been performed with promising results, along with the starts of two new collaboration projects for long-acting peptides using the FluidCrystal technology.
With this short run-through of activities in the third quarter and wrapping up, I'm pleased with the continued performance of our teams and the progress that we have made during the quarter, which has resulted in robust profitability, solid double-digit growth of Buvidal, Brixadi launch continuing to progress in the US, regulatory progress for CAM2029 in acromegaly, along with early pipeline progress, including the CTA submission for our once-monthly semaglutide. As a result of the solid performance to date, we have raised our outlook for the full year 2024. With that, that's my last note. Thank you for your attention, and Einar, please take over the call for Q&A.
Thanks, Fredrik. As a reminder, if you wish to ask a question, please dial #5 on your telephone keypad. The first question comes from the line of Christopher Uhde from SEB. Please go ahead.
Christopher Uhde from SEB.
Sorry.
Thanks for taking my questions. No problem. So my first question is on the U.S. market dynamics. What can you tell us about how that looked during Q3, especially with respect to long-acting injectables versus sublingual, and maybe reasons for your confidence in a strong Q4?
Yeah, I think overall, if we're looking at the segment, the third quarter was slowing down slightly in terms of growth pattern. And we saw, of course, other products not having a strong performance in the third quarter. We believe this is partially due to the seasonality over the period, and we have no information suggesting that we should not have a stronger continuation of the year in Q4. And that is also based on the fact that we saw a pickup in September.
Okay, great. Thanks. And then, so we haven't historically seen clear seasonality in Europe, even though it obviously makes perfect sense that there must be some. Why are we seeing it more clearly now? And then, are you still expecting Buvidal to be stronger in Q4 than earlier quarters this year?
Yeah, I think regarding the seasonality for Buvidal, sometimes this has been, what should I say, disguised by single orders, which if we have a single country order that comes in, it may, but we see overall in market sales in the relevant.
We seem to have lost Fredrik's line. Are you there, Christopher?
You hear me?
I'm hearing you.
Yeah, now we hear you again. Yes.
I can hear you.
Did you?
I think we lost you. We lost you at the seasonality sometimes is disguised by single orders from one country or another.
Yes, that was Richard. Do you want to follow up on the rest of the question?
Yes. I mean, actually, the Q3 growth was the same as against Q2 was the same as Q2 against Q1. So we have the underlying growth there. It certainly is seasonal there. We saw a pickup at the end of the quarter, as we usually do in September. So we have confidence for Q4.
Okay. And then, I guess, why was there a sequential drop in marketing and distribution? And does the CRL impact your plans for the timing of the ramp-up of SG&A during the rest of the year? And then related to that, well, yeah, I guess that's my last question. Thanks.
Yeah. So thanks for the question, Christopher. So just two thoughts to answer you. On one hand, from Total OpEx point of view, although you asked marketing and distribution, if we change historically, I've been referring to historical patterns. Historically, the OpEx of the company, 2023 and 2022, Q3 is lower than Q2. There are mainly two reasons behind it. One is seasonality. Our employees go on holidays. Our consultants also go on holidays. So we don't get invoicing from the third-party consultants. And the holidays of our employees, they go against the accruals that we are reversing. So usually, it's lower, and you can see the patterns in the past. This year, the pattern is also impacted by the fact that in Q2, our employees exercised around 670,000 stock options, that the cost of this they are not any longer in Q3.
So when we are comparing Q3 to Q2, that's an impact on the positive side, in spite of we have been increasing our investment in the US, and in fact, that we are still committed to continue investing in the range of SEK 0.6 billion-SEK 0.65 billion at the end of the year in R&D, as we explain in our guidance.
I think if you're.
Thank you very much.
Yeah, sorry. Please continue. Einar.
Sorry, the next question from Brian Balchin from Jefferies. Please go ahead, Brian.
Hey, guys. Thanks for the question. Yeah, thanks for the question. Just a clarification on the closing aggregate. It seems like you were able to address those manufacturing issues faster than expected. So when you say outcome in December, I just wanted to clarify if that means you've already resubmitted your NDA, because it sounds like you haven't. And then if you can just give us a sense of whether you're expecting class one or class two, because I think base case is class two for a Q1 potential approval. And then second, just on GEP-NET push-out, can you just share your thoughts on how we should be interpreting that, just as I'd have thought patients would be accruing events at a faster pace, given the skew to the more severe grade two, three?
Yeah.
Thank you.
Yeah.
So the first question was a hopeless clarification about the we expect class one or class two.
Oh, yeah. Yeah, yeah, yeah. So I mean, what happened, Brian, sorry, is that the inspection was very close to the PDUFA date. And when you do a CGMP inspection, typically, the agency has a 90-day period for addressing the response to the observations and then issuing a classification. And the classification is, of course, the end result. So what we are waiting for is the manufacturer has responded according to the normal schedule for these inspections. And 90 days will be in the beginning of December when they will receive their classification. And provided that that classification is satisfactory, which we have to presume, then we will be able to resubmit the NDA. And as there are no other issues relating, so it will just be an update of the safety database to a new updated date. So that's basically the progress.
Our base case is that this would be a class one resubmission, so a two-month review period. Should the agency decide that they want to have another inspection, then it's much more likely that it will be a six-month review period. That's my understanding. When it comes to the discussion around the GEP-NET and the progression-free survival, so when we did our analysis to guide for the reaching the target number of events, we have done that based on historical matched control. We have looked at all the studies that we have been able to get data from, published and unpublished. And we have made our comparison to patients with a similar profile in terms of Ki-67 and proliferation or grade, for that matter. That has been the outset.
In the study, of course, we had comparing, for instance, to CLARINET, we had a majority of patients, as I communicated, being grade two and even some grade three patients, whereas in other studies, including then CLARINET, they had a much lower disease severity and only maybe 20%. I should also clarify that we have patients with Ki-67 above 10 to all the way up to over 20, which is the proliferation rate, we would say, of the tumors. Is that?
Super helpful. Thanks, Fredrik. Yeah, yeah, yeah.
Is this going to be clear?
Yes, it is. Yeah. Thank you, guys.
The next question is from Viktor Sundberg from Nordea. Please go ahead.
Yes, hi. Thanks for taking my questions. So first on Brixadi, there is a bit of a disconnect, I guess, between the wording from Indivior that you're being impacted by competition from Brixadi. But looking at your numbers, they don't really imply that you're taking massive market share or that your partner is, in this quarter at least, or taking market share in a way that would lead one to believe that Indivior is losing to you so badly that you need to guide differently and Sublocade. But I guess that has to be the case because there are no other main competitors, as they hold quite insignificant market share outside of the prison system.
So maybe if you can help us understand what you're seeing in the U.S. at the moment or what you hear from your partner in terms of how you are eating into the market share in long-acting buprenorphine? I start there. Thanks.
I think, first of all, I mean, the majority of patients are not coming from another long-acting injectable, but they are actually coming from the sublingual segment. So I would say up towards 70% of patients are coming from sublingual treatment, which we are very happy with. So in that sense, you're completely right that we are not eating up the long-acting injectable market, at least not numerically. And I think that's a positive evolution. Overall, I think that the third quarter, as I said, looking at the entire market, it was a slower quarter. And that's an important comment in addition to that. Jon, do you want to say anything else about Richard?
No, I get the point Viktor is doing. We are growing. We are penetrating with Brixadi, but we cannot comment, Viktor, on the data another company is doing. We continue penetrating the market. We are gaining market share. In fact, I think one of your colleagues, one of the market analysts, has published this morning an estimated number of patients already in the range of 15,000 patients, and these are the data we are tracking, so we can talk about our penetration and our estimated market share, but not about what other companies are talking about, Viktor. We are sure that we continue penetrating. 15,000 patients, estimated by one of your colleagues, I think, is a decent amount of patients for a product in the market after one year.
And overall, I think the general sense we are getting from the market is overall positive, and we are expecting Q4 to be strong. How strong, I cannot say at this time point. We will just have the numbers, and I think we'll be able to give more important, I would say, long-sighted indications after the next quarter. We're still early on, I believe, in the development. But the U.S. market continues to be very attractive, and I think the possibilities are significant. It's a matter of execution, commercial execution.
Okay. And my second question is also on Sorrento. So I'm a bit worried here that we have a poor sense, or at least by looking at historical data, how well the controller would perform in your study design. But can you perhaps help us understand what exactly you have assumed when you designed the study in terms of median PFS that we should expect from the physician's choice of other long-acting somatostatin analogs?
Yeah, we can do that. I mean, our assumptions from start, so to speak, when we powered the study, as I said, was a 0.65 hazard ratio. And we were assuming an 18-month PFS in the control group. And obviously, then you can translate that into the PFS in the active arm, which will then be.
Okay. Thanks.
Yeah. Is that okay?
Yeah, that's clear. And maybe I'll sneak one in on guidance also. What's the major reason for upgrading your sales guidance, given the slightly softer Q3? Is it forecasted the Brixadi sales tick up in Q4, or is it Buvidal XUS that you think that make you confident enough to raise top-line guidance? Thanks.
In the end, the increase in the top line, Viktor, is very modest. And what it makes us strongly believe on it is the performance of both Buvidal and Brixadi. There is not only one main driver, as you tried to point. It's both products. It's the same product, but both of them, they are performing equally strong since the second half of this year. So it's both of them. But again, the top-line increase, as I think someone of you has written this morning, is modest.
Yeah. Thank you.
The next question is from Mattias Hägglund, Handelsbanken. Please go ahead.
Yeah. Thanks so much. I have two questions, please. Coming back firstly to the phasing of OpEx, I thought one of the consequences of the CRL for CAM2029 would be that you pause the build-out of the US organization during the remainder of 2024 to ensure that you get the FDA approval early 2025, and then you speed on. But I guess my first part of the question is, what does guidance really imply? Because it sounds to me that you're sticking to what you've said before in terms of commercial build-out as well as the R&D spend at similar level compared to last year. And then second question related to long-acting GLP-1 for obesity, what comments do you have in relation to Norway's recent joint development with Ascendis Pharma to develop a monthly semaglutide for obesity using Ascendis TransCon technology?
Would you mind comparing and contrasting TransCon to FluidCrystal as a platform? Thanks so much.
Yeah. Yeah. I mean, do you want to start with the first question, Jon, or?
The OpEx? Yeah. So on the CRL impact of our OpEx estimates for Q4, we have always been transparent that the sales force team would join upon positive outcome of the PDUFA date. And we were expecting 21st of October. And I think when we were having prior earnings call, we were sharing that the sales force would be joining mid-November, second half of November. So the impact of postponing this is limited, modest in our estimate of the OpEx for this year because it's only one month of the sales team on the field. Let's not forget that we have already made public that many of the strategic positions and payer access and market access, they are already on board. So that's a limited impact in our OpEx estimate. And yes, we are committed to invest SEK 0.6-0.65 billion in R&D following the development of our pipeline.
I think we are already in SEK 516 million as of the end of September. So we think we are going to deliver it. So this is a bit of a summary of Q4 investment.
I think we should also comment that we are really continuing to invest in the US build-up. So as Jon said, we are not onboarding the sales force. However, we have very positive signals from the ones that we have identified and continued interest. And we will onboard as quickly as possible. But we have actually built out the organization and had new employees joining since the CRL. So we have a very strong focus and belief in that in the US. With regards to the agreement between Norway and TransCon, I guess I have only seen some comments from a press release that was shared with me by an investor. And I mean, we have our focus strategy in this field. Comparing the TransCon technology to the FluidCrystal, one is lipid-based, as you know, which is the FluidCrystal technology, whereas the TransCon technology is based on hydrogel.
To my understanding, it requires the formation of chemical bonds. It's been successfully applied to at least two approved products at this stage, a PTH product and also human growth hormone. I think it's an interesting, however, different technology. But when it comes to the agreement between the two parties you referred to, I don't have a comment. We are very clearly focused on our own agenda at Camurus.
That's very helpful. Thanks so much. One quick follow-up. Conceptually, how should we think about R&D spend linked to Sorrento, given that it's now assumed to run into late 2025, early 2026? Is the vast majority of the cost already taken, or help me think about that, at least conceptually?
So when you are talking about the vast majority of the cost, it depends on which other costs you are assuming. But internally, our assumption is that the latest part of the milestones, they will go with extension of the project, and we will have continued running expenses for more six to nine months, bearing in mind the statement Fredrik made in his letter. So yes, we are going to have additional running expenses, but we are well equipped to finance and to invest on them. And still, our vision for 2027 remains intact. There's no change.
Thanks so much.
Next question from Dan Akshuti from Pareto Securities. Please go ahead. Your line is open.
Congrats on the continuous progress. That's just one question that is left. And that would be, if you can share that with us, what kind of patients are you getting in the U.S. that have not previously been treated to kind of understand the uptake in that bigger market that you mentioned that is out there? How is Brixadi penetrating into these kind of new patients?
Thank you. Thank you so much. That's a good question, Dan. Unfortunately, I can't give you a granular answer on that. I mean, the focus initially has, of course, been on the switch patients. I believe that this is your kind of traditional. That's where the large pool of patients is. There's a lot of activities going on in the U.S., though, I mean, in terms of investigator-initiated trials and so forth, involving also even going into the setting. But I would say that at this time point, it's still a small fraction of the overall number, at least from the data we have seen, and we have access to the public data we have access to. It's still a small fraction if you're looking at the direct initiations. But it's a big opportunity.
Okay. Thank you.
The next question is from Oscar Bergman from Bryan, Garnier & Co. Please go ahead.
Yeah. Hi, team. Thank you for taking my question. Regarding the upcoming semaglutide trial, I'm just wondering how many patients in the phase one you plan to recruit and if you would already be able to guide on how much that would cost approximately, and then maybe as a quick follow-up question, how do you think in terms of later stage clinical development plan for this trial, for this product? Thank you.
In terms of the number of patients, I can only refer to. We haven't gone out with any information. If you look at our similar trials that we have conducted, that are those escalating trials, and in this case, also with a comparator, you're not talking about 10 patients, but rather up towards the 100 number. I don't think we have disclosed anything more than that, but that's the order of magnitude. Aside from that, we have not gone into our detailed continued development or long-range plans for this. We're conducting the study, and we will be looking at next steps along with the performance of the phase 1 and other activities that are ongoing in this space.
Okay. Great. Thank you.
The next question is from Erik Hultgård Carnegie. Please go ahead.
Yes. Hi. Thanks for taking my questions. I have two, if I may. First, from Buvidal. Can you say something about your confidence level in hitting the 100K patient target that you have set up for 2026? If we look over the past, I guess, three years, it's been quite a steady increase of around 3K patients per quarter. And I assume hitting that target would require an acceleration to around 5K patients per quarter. So I was just wondering if you could highlight the sort of key catalysts or events to get to that accelerated number of new patient starts?
And then secondly, on Brixadi, maybe I understand and acknowledge that you're not in control of the launch and don't have all the details, but I was just wondering if you could share something about new market NRx shares for Brixadi compared to Sublocade in the US and how that has changed since the last quarter? Thank you.
Yeah. With regards to the first statement, I'll leave that over to Richard. But I mean, we have not changed. We have still our target is still 100,000 patients. And obviously, there are two components of that: penetration and market expansion. So maybe, Richard, you can go in.
Yeah. I mean, what I can say is certainly the demand for Buvidal remains high. We see from clinicians and from patients that we've got growing numbers there. There are some hurdles at the moment that we're addressing around funding and reimbursement in new markets. And I mentioned earlier that we've got some new markets that we think will come over the line in the end of this quarter. So our plan is based on addressing some of those hurdles that free up the access because we know where we have freed up the access, the penetration is very high. So you can look at some of the countries like Australia and the Nordics where there isn't a hurdle. We see high penetration. So our activity now is to address those hurdles so we can grow faster.
And one thing we are doing also in addition to that is that we have a huge opportunity in the methadone market. And we are working now increasingly with a focus on both the methodology for switching patients easy and conveniently, as well as building out that market because we believe that is a large opportunity going forward here. So can you repeat? I didn't hear about the Brixadi comparison you wanted, Erik. I missed out on that. I'm sorry.
No worries. So my question was basically around new prescription share compared to Sublocade in Q3 compared to Q2. I acknowledge that you don't have all the details maybe, but if you can share what information or intel you have from external market research, that would be helpful. Thank you.
Yeah. Well, I mean, the market share is growing. We can say that from a total patient perspective, it is about 20% at this point in the U.S., which I think is a good number, and higher in, what should I say, the new-to-treatment group or new-to-treatment population. But I don't think I can share anything more detailed because the data sources we are having access to a few data sources, and it's difficult to give more precise information at this point. But that's the order of magnitude.
Great. Thank you. And just to follow up on the methadone, sort of converting patients from on methadone, when do you expect that to happen? Is there a specific event, or will that be gradual progress over the course of next year?
Yeah. We are progressing both from, I would say, interaction because, I mean, if you're looking at the labeling and so forth, it's a little bit more cumbersome. The approach right now, you have to come down to low methadone doses before you can switch over to Buvidal or another buprenorphine treatment. So there is a lot of activities going on in that area to try to develop the methodology, but that's kind of outside this. We are focusing on, and there is a large demand among methadone patients to switch to a long-acting treatment. And from a commercial standpoint, that's our focus.
All right. Thank you so much.
Next question from Patrick Ling from DNB. Please go ahead.
Great. Thank you, guys. Just two short ones. Just wondering, I mean, you mentioned that there's been an independent safety committee that has looked at safety in the SORRENTO trial at six points in time. Have they also at some point looked at some sort of futility analysis for the trial?
Good question. We don't have any futility analysis in the trial built in. So they are exclusively looking at safety data.
Okay. Great. Understood. Then my second question is, I mean, since you're guiding on pre-tax profit, what are your thoughts on interest rates coming down globally and you have a huge pile of cash? I don't really understand actually why you're guiding on pre-tax instead of operating profit, but maybe you can shed some light how you think we should think about your large pile of cash.
You are asking two different questions. I'm not sure which is the one you are raising, Patrick, but I will try to reply. It's true. I'm here. I'm listening to you, so sorry for that. But your question is the amount of cash. The company is building up a solid position, and we did an ECM in January. The use of proceeds was very transparent. It was written there. And we are doing the job to accelerate GEP and NET as much as we can. We are trying to enhance our capabilities in the manufacturing area, and we continue the search of trying to find assets that they can be synergistic to us, that they can accelerate our growth, also increasing the return of the investment of our sales forces because then we have sales forces with capacity for another product. To find these assets, it takes time.
It's not difficult to find an asset. It takes time to find the right one and with quality, and when this comes, we will be prepared to execute the transaction, so that's our strategy for our cash. Our guiding principles for capital allocation have not changed, so they are transparent, so that's why we are building up this, Patrick.
but we take your comment about.
Sorry.
Continue.
No, sorry. I mean, that was not really what I meant. I mean, it's kind of unusual that you guide on pre-tax because in your case right now, you have a big pile of cash, and when you do an acquisition, you will probably not have that. So the question is really, why are you guiding on pre-tax rather than on operating profit?
The question is, when we prepared this year's financials, we thought it would be easier to provide pre-tax because it's closer to the earnings per share, bearing in mind the different tax losses that there are in our balance sheet, which is transparent information for any shareholder. The main dynamic on our P&L is gross margin, and we are very transparent in the gross margin performance. I think we have been improving it quarter on quarter. The second one is surplus control, and the third one is cash management, but the cash is temporary until we are able to deliver on what we have promised. We don't see any big difference, Patrick, on operating result or on profit before taxes. In the end, what we are focused on is the earnings per share for the shareholders.
Okay. Great. Got it. Thank you.
Thank you, Patrick.
The last questions. I don't have the name there. Please state your name and company. Your line is open.
Thanks. This is James Osborne from Stifel. Just firstly, a clarification. I believe you said that 70% of patients coming onto Brixadi were switching from sublingual formulations. If you could just clarify that, that would be really helpful. And then secondly, just sticking with Brixadi in the U.S., perhaps if you can give some color on Brixadi's progress within the criminal justice system versus other channels, as you say, the switching and new patients, if there's any color there, that would be helpful. Thank you.
Yeah. I think in the first case, this is public data from a public data source where I can confirm that. And when it comes to the second question, I don't think I can provide, unfortunately, any granularity as to the contributions from the different channels at this point. I'm sorry to say. But on the first point, I can confirm your question.
Okay. Great. Thank you very much.
There are no more questions at this time, so I hand the word back to you, Fredrik, Jon, and Richard for closing comments.
Thank you so much, Einar, and thanks, everybody, for your attention today. I particularly want to thank you for coming with great questions, which makes this a much more interesting event. So thank you all for that, and looking forward to the next update in the Q4 call coming here. So hopefully, that will be a very strong result as well. So thank you very much.
This concludes today's call. You may disconnect your lines.