Camurus AB (publ)

Welcome to Camuro'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 Thibard. 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 by our CFO, John Garay, and and the chief commercial officer, Richard . So for those of you who have seen our report today, we have a solid third quarter. with strong profitability and operating performance are 38% 41% constant exchange rate year on year exchange rate during one time revenue in to a total of 480 million. Profit before tax increases by to 165 million in Q3. Our best result so far. Again, excluding the one-time milestone. Based on the performance and Results 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 2.75 billion SEK. Again, we know that in the company. We continue to be focusing on commercial execution, with boomerang sales growing nicely by 22% year-on-year to 428, 421 million. in the quarter. In the U.S., the net sales increased by 39% year-on-year, or quarter-on-quarter, I should say.

Sorry about that. Resulting in a royalty contribution of 58 million SEK to cameras. Our R&D pipeline advanced with positive phase 3 results from our Acrinova 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 CAM 2056 was completed. Based on the strong performance here today, CAMRES remains on track to deliver its 2027 vision.

And with this, I'll leave the word to John for a financial review. Thanks a lot, Fredrik. and good afternoon, everyone. During the quarter, Camus continued his 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, Camus achieved to 384 million SEG in the same period prior year. Excluding 36 million SEG one-time master revenues related to pre-study approval by the FDA in the U.S. in 2023, company revenues grew by 132 million SEG, delivering a growth of 30. which is in the higher range of provided guidance for this year. Boobie dance sales reached 421 million SEK, growing 22% versus prior year and 5% versus prior quarter. Swedish criminal appreciation has impacted negativity reportedly by two points, year-on-year basis, and four points versus prior quarter. The exact sales in the U.S. represented a 58 million SEG royalty income in the quarter, representing a 45 million SEG income versus prior quarter. Company profit before taxes was 165,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000,000, during the quarter and remains strong, ending at $2.75 billion. Moving to the next slide, we can see the main components of our profit before taxes. Company gross margin reached 93% in the quarter. Including one time, it represents an improvement of 222 points per session period prior to the year, driven by three major factors. Firstly, supply chain efficiencies driven by volume. 163 basic points. Secondly, 100 basic points are driven by Brixa deroyality.

After 30 years, FX represented a negative impact of 41 basic points. Total OPEX 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 own territories, expansion of Boobidal into new markets and US operations grew 19% to 112 million SEK. Administrative expenses aligned with corporate evolution to substantiate company development grew 155% versus same period last year to 27 million SEK. Another of the investments reached 163 million SEG, growing 10% versus same period prior year, driven by progress in our preclinical and clinical pipeline. Company profit before taxes reached 165 million SEG. Excluding one-time mass non-revenue impact, it represents an improvement by 92 million SEG, increasing 125% versus same period prior year.

position at the quarter end was 2.75 million seconds. Camus improved its cash position by 184 million seconds at the quarter end, driven by following four factors. Firstly, company operations generated Secondly, working capital generated is $16 million, driven by account receivables reduction mainly. Thirdly, financing activities driven by the exercise of stock options. program delivered $45 million in cash. And finally, the company invested $6 million in second technological activities. At the end of the quarter, Camurus has no... Only now, Camurus closes third quarter with a strong... operational performance and solid financial position. As a consequence, such strong performance year-to-date, and due to expectations, Camur's outlook for total revenue was increased to the range of 1,810 to 1,880 million SEK, from a prior range of 1,730 to 1,840 million SEK. With profit before taxes, to $510 million a second, from a prior range of $330 to $450 million a second. And it's on track to deliver the long-range plan vision shared at Capital Market Day, celebrated in September 2022. Having said that, I will 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 cameras markets and then move to Brickside in the US. So in cameras markets, the third quarter saw further development of Buvidal reaching 421 million SEK, 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 has been across some markets, in particular Germany and the UK, which saw good progress as we continue to implement new initiatives to accelerate patient recruitment.

Other

Markets were slightly stopped 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 Boogdown has supported patients during the time. We're now exploring ways to continue to support patients in the country.

the U.S., Q3 continued the sales development of Brixardi, demonstrated by the increasing royalty to $58 million, a growth of 39% at constant exchange rate compared to previous quarter. The increasing demand Market share comes primarily from the capture of patients from sublingual group of morphine products, and then remains a transfer 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 6%. million people with an OUD diagnosis, and an estimated 1.8 million treated with sublingual treatment. The peak market potential for Brixardi 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 Boverdale 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

of Boverdale and Brixadi in both community and custodial settings. And on that brief update, I will hand back to Frederick. Thank you so much. And over to an update on our core R&D programs. During the second quarter, we advanced our latest clinical development programs of subcutaneous TPO, Chem 2029 across three target indications of acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease. Starting with AcroMegaly and the AcroInnova program. In July, we received positive phase three results from a 52-week open-label AcroInnova study evaluating safety and efficacy of CAM-2029 in newly enrolled patients. and rule over patients from acronym number one. Key findings and observations in this study included a safety profile consistent with that of the current standard of care, with first-generation

metastatin receptor ligand, increased biochemical response rates in the overall population after 52 weeks of treatment with CAM-2029, again, compared to standard of care at baseline. Consistent with AcroInnova 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 Microrhinova 1 have been accepted for publication in 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 3 Sorento study. As a reminder, Sorento is the largest prospective randomized controlled trial of a somatostatin receptor ligand in gastroenteropatriotic neuroendocrine tumors.

The study is designed to assess superiority in progression-free survival of CAMP2029 compared to investigators' choice of studies. of care with octreotide LAR or lanreotide octogel. A broad population of GET patients with advanced metastatic inoperability trouble, well-differentiated neuroendocrine tumors of grade 1 to 3 have been included in this study. power 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, with the 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 endpoints. The analysis points to longer-than-expected PFS for the patient population in the Sorento tribe, of which a majority had more advanced disease with the 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 first half of 2025 to late 2025 or early 2026.

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 phase,

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 the recommendation for orphan drug designation for CAM29 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 technical programs for CAN 2029. Moving over to regulatory, I will not As you are aware, we received a CRM from FDA on the 21st of October. That is a complete response letter. After having had a late ongoing labeling decision, discussions with the agency. The CRL was strongly related to observations during a CGMP inspection at a third-party manufacturing facility and did not raise any concerns relating to Camp 2029, including safety or for that matter, quality. Unfortunately, the timing of the inspection precluded resolution of the observations by the PDUFA page. Since the inspection, the manufacturing has answered all the observations and is expecting a classification by early December. Providing this is satisfactorily addressing the the agency's observation cameras 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 they're 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 fluid crystal technology. So with this short presentation, 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 Booby Love, the exciting launch continuing to progress in the U.S.,

regulatory progress for CAM2029 and 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. And with that, that's my last note. Thank you for your attention and please take over the call for Q&A. Thanks, Fredrik. As a reminder, if you wish to ask a question, please type poundkey5 on your telephone keypad. The first question comes from Christopher Ude from Nordea. Please go ahead. Christopher Ude from SEB. 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 sublinguals? 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 patterns. 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 had 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 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 Buvedal to be stronger in Q4 than earlier quarters this year?

Yeah, I think regarding the seasonality for Buvedal, 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 hearing you. Now we hear you again. Yes.

Now I can hear you. Did you... I think we lost you. We lost you at the seasonality sometimes as the guys by single orders from one country or another. Yes, that was... Richard, do you want to follow up on the rest of the questions? Yes, I mean, actually, the Q3 growth was the same as against Q2. It 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 steps. 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. So, for the question, Christopher, so you have two folds to answer. On one hand, from a total of point of view, although you asked marketing and distribution, if we check historically, I've been referring to historical patterns. Historically, the effects of the company, 23 and 22, usually is lower than 22. There are mainly two reasons behind it. One is seasonality. Our employees go on holidays. Our consultants 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 it usually is lower and you can see the patterns in the past. This year, the pattern is also impacted by the fact that in Q2, our project exercise around 670,000 options, that the cost of this, they are not any longer in Q3. So when we are comparing Q3 to the future, that's an impact on the positive side. In spite that we have been increasing our investment in the U.S. investing in the range of point six point sixty five million a second yeah

Please continue.

Sorry, the next question from Brian Bolshan from Jefferies. Please go ahead, Brian.

Hey guys, thanks for the question. Yeah, thanks for the question. Just a clarification on the clays in agri-magazine. It seems like you were able to address those manufacturing issues faster than expected. 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 1 or Class 2, because I think base case is Class 2 for a 2Q potential approval. And then second, just on GetNet pushout, can you just share your thoughts on how we should be interpreting that

just as I'd have thought patients would be given this grade two, three. Thank you. Yeah. So the first question was about So, I mean, what happened, Brian, sorry, is that the inspection was very close to the PDUFA date. And when you do a GCG inspection, typically 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 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 would just be an update of the safety database and to a new updated date. So that's basically the progress. And our case is that this would be a class one review period. Should the agency... decided 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 When it comes to the discussion around the GetNet and the progression-free survival, 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. And 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 2 and even some grade 3 patients, whereas in other studies, including then clarinet, they had a much lower disease severity and only maybe 20%.

And I should also clarify We find that we have patients with KI-66 at 7 above 10, all the way up to over 20, which is the proliferation rate, we would say, of the tumors. Yes, it is.

Thank you, guys.

The next question is from Victor Sombar from Nordea.

Please go ahead. Yes, hi. Thanks for taking my questions. So first on Brick Study, there is a bit of a disconnect, I guess, between the wording from the viewer that you're being impacted by competition from Brick Study. 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.

We're taking market share in a way that would lead one to believe that the individual is losing to use of 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 control as quite insignificant market share outside of the prison 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 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're 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 not eating up the long-acting injectable market, at least not numerically. And I think that's a positive evolution. Overall, I think that this third quarter, as I said, looking at the entire market, It was our quarter, and that's an important comment in addition to that. John, do you want to say anything else about us? Richard? No, I get the point that Victor is doing. We are growing.

We are benefiting with Vixadia. 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 this is the data we are tracking. So we can talk about what other companies are talking about, Victor. 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 a product in the market after one year.

And overall, I think the general sense we are getting from NACID is overall positive and we are expecting Q4 to be How strong? I cannot say at this time point.

We'll just add the numbers and I think we'll be able to give more important long-sighted indications after the next quarter. This is 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. 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 control would perform in your study 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 stomatostatin analogs. Yeah, we can do that. Assumptions from the 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 effects in the active arm, which will then be, yeah. Is that okay? 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 to be that the sales pick up in Q4, or is it booby-doll XTOS that you think that make you confident enough to raise top-line guidance? Thanks. In the end, the increase in the top line victories is very modest. What makes us strongly believe on it is the performance of both movies. It's not only one main driver. As you try to point this out, Both products, it's the same product, but both of them, they are performing equally strong within the second half of this year. So it's both of them.

But again, the top line increase, as I think some of you have written this morning, is modest.

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

Yeah, thanks so much. I have two questions, please. Coming back firstly to the facing of OPEX, I thought one of the consequences of the TRL for CAM 2029 would be that you paused the build-out of the U.S. organization during the reminder of 24, to ensure that you get the FDA approval early 25 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 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 and GMP1 for obesity. What comments do you have in relation to all those reasons? So it's the partner with Ascended Pharma. Ascended Transcontact. technology, and would you mind comparing and contrasting Transcom to Fluid Pistol as a platform? Thanks so much. Yeah. I mean, do you want to start with the first question, John, or...? Yeah, so... So, we... on this... We have always been transparent that the Salesforce team will join a positive outcome of B2-5.8. We were expecting the 21st of October, and I think when we were having a private meeting in school, we were sharing that the Salesforce team will join. 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 it public that many of the strategic positions That's a limited impact in our APEX estimate. And yes, we are committed to invest 0.6, 0.65 billion in R&D following the development of our pipeline. I think we are already at 516 million a sec. So we think 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 onboarding the sales force. However, we have very positive signals from the ones that we have identified. And we will onboard as quickly as possible. But we have actually built out the organization and have new employees joining since the ECRL. So we have a very strong... strong focus and believe in that in the US. With regards to the agreement between Novo and Transcom, 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, you know, the formation of chemical bonds. It's been successfully applied to at least two approved products at this stage, a PTH product, 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 Canberras.

That's very helpful. Thanks so much. One quick follow-up. Conceptually, how should we think about R&D spend linked to Surrento, given that it's now starting to run into late 25, early 26? You know, is the vast majority of the cost already taken? Or, you know, 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 cost you are assuming. six to nine months based on the statement that Jeremy made in his letter. Yes, we are going to have additional running expenses, but we are well equipped to finance and to invest. Again, I think our vision for 2027 remains intact. It's not changed. Thanks so much.

Next question from Dana from Pareto Securities.

Please go ahead.

Your line is open.

Congrats on the continuous progress. One question that is left and that would be if you can share 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 quick study penetrating into these kind of new situations? Thank you so much. That's a good question, Dan. Unfortunately, I can't give you a great answer. I mean, the focus initially has, of course, been on the switch patients. I believe that this, you know, 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 investigating re-initiated trials and so forth involving walls so even going into the er setting but i would say that it's at this time point it's still a small fraction of the overall number that that

at least from the data we have seen and we have access to, 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 from Oskar Hafenlam from Brian Garnier. Please go ahead.

Yeah, hi, Tim. Thank you for taking my question. Regarding the upcoming semaglutide trial, I was 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.

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 and in this case also with the comparator, you know, you're not so I'm talking about 10 patients up towards 100. So 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 the 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 from Erik Pultgård, Carnegie. Please go ahead. Yes, hi. Thanks for taking my questions. I have two, if I may. First, can you say something about your confidence level in hitting the 100,000 patient target that you've 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 the sort of catalysts or events to get to that accelerated number of new patient starts. And then secondly on Bricsad, maybe I understand and the but I was just wondering if you could share something about new market and direct shares for

compared to sublocated in the U.S. 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 Booberdale remains high. We see from clinicians and from patients that we're 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.

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 methadone.

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 Bricsati comparison you wanted. Eric, I missed out on that. I'm sorry. No worries. So, my question was basically around new prescription share compared to sublocated in Q3 compared to Q2.

I acknowledge that you don't have all the details, but if you can share what information or intel you have from external market research, that would help.

Thank you. The market share is growing. We can say that from a total patient perspective, it is about 20% at this point in the US, which I think is a good number. and higher in, what should I say, the neutral treatment group or neutral treatment population. But I don't think I can share anything more detailed because the data sources are... We are having access to a few data sources and they... 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 method on converting patients on methadone, when do you expect that to happen? Is there a 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, 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 Viviron 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, and from a commercial standpoint, that's our focus.

All right, thank you so much.

Next question from Patrick Ling from DMB. 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 tribe for six points in time. Have they also at some point looked at some sort of utility analysis for the tribe?

Good question. We don't have any utility analysis in the tribe yet then.

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 in profit.

Maybe you can share some lights 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. 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... We did an ECM in January. The use of proceeds was very transparent. It was written there. And we are doing the job. We are trying to enhance our capability. It is manufactured in India. And we continue the search of trying to find assets that they can be signalistic to us, that they can accelerate our growth, also increasing the return on investment of our self-possess, because then we have self-possessing capacity for another product. To find these assets, it takes time. It's not difficult to find an asset. It takes time to 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. They are transparent. So that's why we are doing that. That was not really what I meant. It's kind of unusual that you guide on pre-tax because in your case right now you have a big and 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, financials, we thought it would be easier to process

because it is closer to the earning per share, bearing in mind the deferred 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. And the second one is surface control, and the third one is cash management, but the cash is temporary until we are able to We are focusing the only pressure for the shareholders.

Okay, great. Got it. Thank you.

Thank you, Patrik.

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 on to Brixardi was switching from subliminal formulations.

If you could just clarify that, that would be really helpful. And then secondly, just thinking of Brixardi in the US, and perhaps if you can give some color on Brixardi's progress within the criminal justice system versus other channels, as you said, switching and new patients, if If there's any colour there, that would be helpful. Thank you.

Yeah, I think in the first case, this is public data from a public data source, so I can confirm that. And when it comes to the second question, I don't think I can confirm that. 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 and Richard, for closing comments.

Thank you so much, Einar. 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 there will be a very strong result as well. So thank you very much. This concludes today's call.

You may disconnect your lines.