Camurus AB (publ)

Welcome to Kamuro's Q3 Report 2024. During the questions and answer session, participants are able to ask questions by dialing pound key five on the telephone keypad. Now we'll hand the conference over to CEO, Fredrik Tibar, please go ahead.

Thank you so much and hello everyone. Welcome to our Q3 2024 earnings call today. Before starting, please note our forward looking statements. The agenda for today is like previous quarters, a short summary of third quarterly business highlights, followed by a review of our financial performance, and then we will go into commercial and R&D updates and finish off with the Q&A.

I'm joined in today's call by our CFO, Jong-Garai, and Chief Commercial Officer, Richard Gaines. So for those of you who have seen our report today, we have a solid third quarter with strong profitability and operating performance. Our revenues grew by 38%, 41% at a constant exchange. A straight year earlier, -to-結果虎字 demonstrate revenue in the year past and return it by 93. and to 125 million in Q3. Our best results so far. Again, excluding the one-time milestone. Based on the performance and the results we have raised our outlook for the full year 2024. Particularly as regards to profit performance and our cash flow. The position at the end of the quarter increased to 2.75 billion SEC. Again, with no debt in the company. We continue focusing on commercial execution with BVRAO sales growing nicely by 22% -on-year to 421 million SEC in the quarter. In the US, net sales increased by 39% -on-year.

Resulting in a royalty contribution of 58 million SEC to cameras. Our R&D pipeline advanced with positive phase three results from our Acrenova 2 study. Our USMDA 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 USMDA process the regulatory MAA review moved forward in the EU. Additionally, preparations for the first clinical study of monthly semaglutide depot CAM2056 was completed. Based on the strong performance here today, cameras remain on track to deliver its 2027 vision. And with this I leave

the work of Robert John for a financial review. Thanks a lot, Federico. Good afternoon, everyone. During the quarter, cameras continue to deliver strong financial performance and I would like to share now the key highlights of this quarter. At the end of the quarter, CAM2056 achieved 480 million SEC total revenue compared to 384 million SEC in December period prior year. The student's revenue grew by 172 million SEC, delivering a growth of 38% versus certain period prior year. Which is in the higher range of providing guidance for this year. Moving down since increased 421 million SEC, growing 22% versus prior year and 50% versus prior quarter. Shoulder scruel representation has impacted the activity of the report. It goes by 2 points -on-year basis and 4 points versus prior quarter. The company sells in the US representing 58 million SEC, and the incoming quarter representing 45 million SEC. Company profit before taxes was 165 million SEC, achieving an annual share-effect evolution of .16% per year. The company profit after taxes of 129 million SEC in the quarter. Finally, our cast position progressed positively during the quarter and remains strong, ending at .72.5 billion SEC. Moving to the next slide, we can see the main components of our profit before taxes. Company gross margin increased 93% in the quarter, excluding one time. The revenue impact represents an improvement of 222 million SEC, which is in the same period prior year, driven by three major factors. Firstly, supply chain efficiencies driven by moving without volume increases. The scale of that represented 163 basic points. Secondly, 160 basic points are driven by brisk study royalties.

Thirdly,

the effects represented a

negative impact of 41 basic points. Total OPEC reached 304 million SEC, representing a 21% increase versus same period prior year, driven by following factors. Marketing and distribution investment to support market penetration in owned territories, expansion of public data into new markets and US operations grew 19% to 112 million SEC. Administrative expenses aligned with corporate evolution to substantiate company development grew 155% versus same period last year to 27 million SEC. Another investment reached 163 million SEC, growing 10% versus same period prior year, driven by progress in our preclinical and clinical lifetime. Company profit before taxes reached 165 million SEC, excluding one time mass non-revenue impact, representing an improvement by 92 million SEC, increasing

125% versus same period prior year. Company cash position at the quarter limit was 2.75 billion SEC. Commercial growth improved its cash position by 184 million SEC, driven by following four factors. Thirdly, company operations generated 161 million SEC, driven by a count of 0.3 reduction of 90. Thirdly, financing activities driven by the exercise of social programs delivered 45 million SEC cash, and finally, company invested 66 million SEC in technological activities. At the end of the quarter, Camourus has no profit. All in all, Camourus closes third quarter with a strong operational performance and solid financial position. As a consequence, as of such strong performance the -to-date and before expectations, Camourus outlook for total revenue was increased to the range of 1810 to 1880 million SEC, from a prior range of 1700 to 1840 million SEC, with profit before taxes estimated in the updated range of 450 to 570 million SEC, from a prior range of 372 to 570 million SEC, and is on track to deliver the long-range plan vision shared at Capital Marketing, celebrated in September 2022. Having said that, I would like to pass the word to Richard. Thank you everyone for your attention. Thank you John. So I'll start with an update on the Camourus market and then move to the U.S. So in Camourus markets, the third quarter saw the further development of Buvadel,

reaching 421 million SEC,

24% -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 in across some markets, in particular Germany and the UK, which saw good progress as we continued

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 -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 Buvadel has supported patients during the time. We're now exploring ways to continue to support patients in the country. And

we're moving on to Q3. The increasing market share comes primarily from the capture of patients from sublingual group of northing products and then remains a transfer from other long-acting injectable products or being direct initiations. As we've communicated before, the European opportunity in the US is significant with an estimated more than 6 million people with an OUD diagnosis and an estimated 1.8 million treated with sublingual group of northing products. The peak market potential for the study is significantly above 1 billion US dollars, 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 Buvadel 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 of Buvadel and Brickside in both community and custodial settings. A brief update that we'll hand back to Fred. Thanks so much. And over to an update on our core R&D programs. During the second quarter, we have launched our latest-stage clinical development program, programs of autotruthymes of botanist SIPO, CHEM 2029 across -week-old populations of acromegaly, gastroenteropancreatic neurondotynotinotinomers, and policies to treat liver diseases. Starting with the acromegaly and the acroenova program, In July, we received positive phase III results from a 52-week open-label acroenova study evaluating safety and efficacy of CHEM 2029 in newly enrolled patients and rollover patients from acroenova 1. Key findings and observations in this study included a safety profile consistent with the current standard of care, with first-generation... ... ... increased

biochemical response rates in the overall population after 52 weeks of treatment with CHEM 2029, again compared to standard of care at baseline. Consistent with acroenova 1, 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 acroenova 1 have been accepted for publication in the Journal of Clinical Endocrinology and Metabolism, and after that we'll see them published very soon already. And after that, we'll move over to the GetNet program. I intend to share an update on the progress of the pivotal phase III Sorrento study. As a reminder, Sorrento is the largest prospective randomized control trial of a somatostatin receptor ligand in gastroenteropathyaptic

-crypto-tumors. The study is designed to assess superiority in progression-free survival of CHEM 2029 compared to investigators' choices... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... outcomes into overall survival, multiple patient reported outcomes, and of course safety. So, the relative to this global study with the geographic distribution of patients

as we see 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 to guide the expected time for reaching the target number of PFS events. The analysis points to longer than expected PFS

for the patient population in the Sorrento tribe,

of which a majority had more advanced response disease with a grade two neuroendocrine tumors, a grade one and a few grade three disease patients. Based on better than expected human control in the study, the estimated timing for reaching the target number of PFS events has been updated from first half of 2025 to late 2025, which is expected to be around the same time as the first half of 2025 to early 2026. The next external update is expected to be on the red list 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 CAM 2029 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 CAM 2029 in autosomal dominant polycystic

liver disease from the European Commission. So as to summary, here is the updated timeline for our three pivotal clinical programs for CAM 2029. Moving over to regulatory and anatomic imaging and micro-magnetizing. As you are aware, we received a CRL from FDA on the 21st of October. That is a complete response letter. After having had a late ongoing daily discussion with the agency, the CRL was totally unrelated to observations during a CGMP inspection. At the third-party manufacturing facility, we did not raise any concerns relating to CAM 2029, including safety or efficacy for that matter of quality. Unfortunately, the timing of the inspection precluded resolution of the observations by the to-do for the day. 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, cameras will rapidly resubmit the NDA for review. We are working towards a scenario of cross-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 start of two new collaboration projects for long-acting peptides using the fluid crystal technology. So 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 BVDAV, the study launch continuing to

progress in the US. The regulatory progress for CHAMP-29 and ICT along with early pipeline progress including the CTA is a major motivation for our once monthly semaglutide. As a result of the solid performance today, we have raised our outlook for the full year 2024. And with that as my last note, thank you. Thank you, and please take over the call for Q&A. Thanks, as a reminder if you wish to ask a question, please type pound key five on your screen. Please go ahead. Christopher from SCB.

Sorry, I'm predicting my questions. No problem. So, my first question is on the US market dynamics. Can you tell us

about how that looked during Q3, especially with respect to and maybe reasons for your confidence in a strong Q4? 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 that other products not having a strong performance in the third quarter. And we do to the seasonality over the period and we have no other 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 strong 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 BVDOL to be stronger in Q4 than earlier quarters this year?

Yeah, I think regarding the seasonality for BVDOL, sometimes this has been, what should I say, disguised by single orders, which is 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, Kristoffer? You hear me? I'm here. Now we hear you again. Now I can

hear you. Did you? I think we lost to seasonality sometimes as disguised by single orders from one country or another. Yes, that was, Richard, you want to follow up on the rest of the question? So, yes, I mean, the 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 pick up at the end of the quarter, as we usually do in 10, so we have confidence to keep. And then I guess why was

there a sequential drop in marketing and distribution and does the the CRL impact your plans

for the timing of the ramp up of SG&A during the year and then related to that. Oh, yeah, that's my last question. Thanks. So, so that's for the question, Kristoffer. So, you asked two faults to answer you. On one hand, from a total of this point of view, although you asked marketing and distribution, if we check historically, I would refer to historical patterns, historically the impacts of the company, Q3 and Q2, Q3 is lower than Q2. There are many reasons behind this one. This is our employees. So we don't get invoicing from the third party. And the holidays of our employees, they go against the accruals. So usually it's a lower and you can see the patterns in the past. This year, the pattern is also impacted by the the fact that in Q2, our employees exercise around 670,000 options that the cost of this, they are not getting used to. So we are very used to the future that's an impact on the Q2 side. In spite of that, we have been increasing our investment and in the US, we are still committed to continue investing in the range of 0.6. This 0.6, but we can check at the end of the year in R&D as we explain in our guide. And I think if you're...

Please continue.

Sorry, the next question from Brian Bolshin from Jeffreys. Please go ahead, Brian.

Hey guys, thanks for the question. Yeah, thanks. Just a clarification on the closing aggromagic. 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 BLA 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, base cases, class two for a TQ potential approval. And then second, just on getting that push out, can you just show your thoughts on how we should be interpreting that? Just as I'd have thought, patients would be a critical event at

a faster pace given this grade two, three. Yeah. So the first question was a vocalist clarification about the expected class one. Oh yeah. So what happened, Brian? Sorry. It's that the inspection was very close to the PDUFA date. And when you do a GCG, the the agency has a 90 days period for addressing the response to the observations and then issuing a classification. And the classification supports the end result. So what we are waiting for is the manufacturer has responded according to the normal schedule. And 90 days will be the beginning of December when they will receive their classification. I provided that classification is satisfactory, which we have to pursue. Then we will be able to reach the NDA. There are no other issues relating, so it could just be an update of the safety database and to a new updated date. So that's basically the progress. And our base case is that this would be a class one and resubmissions two month review period. Should the agency decide that they want to have

another

inspection, then it's much more likely that it would be a six month review period. That's my understanding. So when it comes to the discussion around the GEPnet and the progression free survival. So when we did our analysis to

guide for reaching the target number of events, we have done that based on historical matched control. So we have looked at all the studies that we have been able to get data from, published and unpublished. We have made our comparison to patients with a similar profile in terms of KI67 and proliferation or grade for that matter. So that has been the outset. And 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 them Clarinet, they had a much lower disease severity. And I

should also clarify that we have patients with KI67 above 10, so all the way up to over 20, which is the proliferation rate of the tumors. Thank you.

Thank you guys.

The next question is from Victor.

Please go ahead. Yes, thanks for taking my questions. So first on Bricsadi, there is a bit of a disconnect, I guess, between the wording from the viewer

that you're being impacted by competition from Bricsadi. 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, taking market share in a way that would lead one to believe that the viewer is losing to use a value that they need to guide differently and sublocate. But I guess that has to be the case because there are no other main competitors as we would call as, you know, insignificant market share outside of the business system. So maybe if you can help us understand what you're seeing in the US at

the moment or what you hear from your partner in terms of how you're eating into the market share in long-acting morphine. I'll 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 this. So I would say that 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 numerically. So then I think that's a positive evolution. Overall, I think that this third quarter, as I said, looking at the entire market, it was a slow quarter and and that's an important comment in addition to that. John, do you want to say anything else? Richard? No, I get the point that Victor is doing. We are growing.

We are benefiting with big study, but we cannot comment Victor on the data another company is doing. We continue penetrating the market. We are gaining market share. In fact, I think one of you 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. We are sure that we continue penetrating 15,000 patients estimated by one of you colleagues. I think it's a decent amount of patients for the product in the market after one year.

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 will be able to give more

importance. After the next quarter. The US market continues to be very attractive and I think the possibilities are significant. It's a matter of execution, commercial execution.

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 this talk today, how well the control lab would perform in your design.

Can you perhaps help us understand what exactly you have assumed when you designed the study in terms of medium PFES that we should expect from the physician's choice of other long-acting so much as that in analogues? Yeah,

we can do that. Our assumptions from the start, so to speak, when we powered the study, as I said, was a 0.65 asset ratio. We were assuming an 18-month PFES in the control group. And obviously, you can translate that into the effects in the active arm. Which would then be. 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 software Q3?

Is it forecasted that it's still pick up in Q4 or is it moved at all ex-DOS? Did you think that would make you confident enough to raise top-line guidance? Thanks. What it makes us strongly believe on it is the performance of both movies. Exactly. There is not only one main driver. As you tried to point out, both products are the same product. Both of them are performing equally as strong. We think it's the second half of this year. So it's both of them. But again, the top line in case, as I think

some of you have written this morning, is modest.

Yeah, thank you. The next question from Mattias Hegglund, Handelsbanken. Please go ahead.

Thanks so much. I have two questions, please. Coming back firstly to the phasing of OPEX, I thought one of the consequences of this year, for CAM29, 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 that actually implied because it sounds to me that you're sticking to what you said before in terms of commercial build out as well as the R&D spend at similar level compared to last year. And

then the second question related

to long-acting and due to one for obesity, what comment do you have in relation to the choice to partner with a standard pharma using this transcom technology and would you mind comparing and contrasting transcom to fluid piston as a platform? Thanks so much. I mean, do you want to start with the first question John? For the OPEX, yes. So, we on the Sierra League have had a lot of OPEX's teammates for Q4. We have always been transparent that the Salesforce team will join at the Pacific Falcon on Friday and we were expecting 21st of October and I was told we were sharing that the Salesforce will be joining in mid November, second half of November. The impact of postponing this is limited modest in our estimate of the OPEX for this year, which is only one month, of the sales team on the field. And let's not forget that we have already made public that many of the strategic positions and markets they are already on board. So that's a limited impact in our OPEX estimate. And yes, we are committed to invest 0.6, 0.65 billion in anatomy following the development of our pipeline. I think we are already in 516 million secs. So, we are going to deliver it. So, this is a bit of a summary of Q4 investment. And I think we should also comment that we are really continuing to invest in the US field. So, as John said, we are not on board in these Salesforce. We have very positive signals from the ones that we have identified and continue to interest and we will onboard as quickly as possible. But we have actually built up the organisation and have new employees joining since the ECRN. So, we have a very strong focus and believe in that in the US. With regards to the agreement between Novo 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 Fluid Crystal, one is lipid based as you know, which is the Fluid Crystal technology, whereas the Transcon technology is based on a 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 refer to, I don't have a comment. We are very clearly focused on our own agenda at Camrs.

That's very helpful. Thanks so much. One quick follow up. How should we think about R

&D spending linked to Surrey? Given that it's now seeming to run into late 25, early 26.

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 of the costs you are assuming. But internally our assumption is that the latest part of the master, we will have continued running expenses for more than six to nine months. Based on my understanding, in his head of the survey, yes, we are going to have additional running expenses, but we are willing to finance and invest on them. thanks so much.

Next question from Dana Kstutti

from Pareto Securities. Please go ahead. Your line is open. Congrats from the continuous progress. One question that was left. If you can share that with us. What kind of in the US 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 the study penetrating into these kind of new situations? Thank you so much. That's a good question. The focus initially has of course been on the switch patients. I believe that this kind of traditional, that's where the large pool of patients is. There's a lot of activities going on in the US, so I mean in terms of investigating, re-initiating trials and so forth involving also. So even going into the ER 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 public data. 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 from Oscar Hafen Lam from Brian Garnier. 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 get on how much that would cost approximately. 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.

So in terms of the number of patients, I can only refer to, we haven't gone out with any information, but if you look at our similar trials that we have conducted

that are those escalating trials, in this case also with the comparator, you know, you're not talking about 10 patients but rather up towards the hundredth number. So I don't think we have disclosed anything more than that, but that's the order of magnitude. Aside from that, you know, we have not gone into our detailed details. Continue development of long-range plans for this. We're conducting this again and we will be looking at the next steps along with the performance of the phase one and other activities that are ongoing in this space. Okay, great. Thank you. Next question from Erik Pultgård, Carnegie. Please go ahead. Yes, hi, thanks for taking my questions. I have two if I may. First, we'll move it out. Can you say something about your confidence level in hitting the one hundred-k patients target that you've set up for 2026?

If we look over the past, I guess, three years, it's been quite

steady increase of around three-k patients per quarter and I

assume

hitting

that target would require an acceleration to around five-k patients per quarter.

So I was just wondering if you could highlight the sort of catalysts or events to get to that rate. Accelerated number of new patient starts. And then second, on Bixárd, the, maybe I understand them and the the launch and the details. But I was just wondering if you could share something about the new market and the

for Bixárd compared to some locations in the US and how that has changed in

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 a hundred thousand 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 BubaDal remains high. We see from clinicians and from patients that we get growing numbers there. There are some hurdles 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.

One thing we are doing also in addition to that is that we have a huge opportunity in the method of markets and we are working now increasingly with

a focus on both the methodology for switching patients easy and conveniently as well as building up that market because we believe that this is a large opportunity going forward here. So can you repeat? I didn't hear about the Bricshadi comparison. You wanted, Eric, I missed out on that. I'm sorry. No worries. So my question was basically around new prescription chair compared to Q3. Sublocated in Q3 compared to Q2, I acknowledge

that you don't have all the details, maybe, but if you can share what information you have from external market research that we have. Thank

you.

Yeah, the market share is growing. We can say that from a total patient perspective, it is above 20% at this point in the US, which I think is a good number, and higher in the new treatment group or new treatment population. But I don't think I can share anything more detail because the data sources are, 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. Just to follow up on the methadone, sort of converting patients from methadone,

when do you expect that

to happen? Is there specific event or will that be a gradual progress over the course of the next year? Yeah, we are progressing both from interaction because, I mean, there is, if you're looking at the labeling and so forth, there is, 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 Vividol or another treatment. So there is a lot of activity that is 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. It's from a commercial standpoint, that's our focus.

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 Serenta trial for up to six points in time. Have they also at some point looked at some sort of utility analysis for trial?

Good question. We don't have any utility analysis in the trial. So they are exclusively

looking at safety data. Okay, great. Understood. Then my second question is, since you're guiding on the 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

in

profit.

But maybe you can share some lights on 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? 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 is starting to position. We did an ECM in January. The use of proceeds was very transparent. It was written there. And we are doing the job of accelerating the capital net as much as we can. We are trying to enhance our capability. It is manufactured in India. And we will continue the search of trying to find assets that can be listed to us, that can asser our growth. Also, it gives us the return of investment and of our self-possessions because then we have the capacity for another product. To find these assets, it takes time. It is not difficult to find an asset. It takes time to find the right one and with quality. When this comes, we will be prepared to execute the transaction. So that's our strategy for our cash, our guiding principles for capital application. How much change? So that's why we are building up this strategy. Sorry,

that was not really what I meant. It is quite

unusual

that you guide on

pre-tax. In your case, right now, you have a big pile of cash. When you do an acquisition, you will

probably

not have that.

The question is really why are you guiding

on pre-tax rather than on operating process? So the question is, when we prepared this year, we thought it would be easier to provide pre-tax because it is closer to the end in per share bearing

in mind the different tax losses that 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 service control and the third one is cash management, but the cash is temporary until we are able to deliver on what we have promised. So we don't see any big difference, Patrick, on operating result or on profit before we are focused on the end in per share for the shareholders.

Okay, great. Got it. Thank you.

Thank you, Baudry.

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 90% of patients coming onto BrickSardi were switching from sublingual formulations. If you could just clarify that, that would be

really helpful. Secondly, just thinking of BrickSardi in the US, and perhaps if you can give some colour on BrickSardi's progress within the criminal justice system versus other channels. As you said, switching in new patients, if there's any colour there, that would be helpful. Thank you.

Yeah, I think in the first case, this is public data from public data sources. That's the second question. 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 Ljönh and Richard for closing comments.

Thank you so much, Aina. 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. Thank you all for that, and I'm looking forward to the next update in the Q4 call. Hopefully that will be a very strong result as well. Thank you very much. This concludes today's call. You may disconnect

your lines.