Camurus AB (publ)

reaching 40 million SEC compared to the same period last year. And then R&D investments were 109 million SEC, a reduction of 33% compared to the same period last year. This is mainly due to the completion of ARCA-RENOVA trials and the absence of clinical trial milestone payments in the Sorrento and Positano programs during the quarter. Looking at the cash flow for the quarter, Chemuris increased its cash position by 167 million SEC, mainly driven by the operational activities adding 221 million SEC and proceeds from the employee stock option program adding 43 million SEC. Working capital investments decreased cash by 97 million SEC, resulting in a net cash position of 3.5 billion SEC, which is an increase of 28% compared to last year. Moving to the update of the 2025 financial guidance. Despite positive development in Brickside and Buberdale, revenue do not live up to our previous expectations and guidance for the full year. This is primarily due to Brickside U.S. revenue is below the previous projections and there is uncertainty about the timing of a sales milestone. In addition, we have seen continued delays in allocation of committed governmental funding for the treatment in the U.K., But importantly, our profitability has continued to develop positively with good financial discipline across the organization, and our planned U.S. expansion has been aligned with the updated approval timeline for both places. As a consequence, our restated full-year 2025 outlook is as follows. Our revenue guidance is lower to 2.3 to 2.6 billion Swedish kroners. and a profit before taxes unchanged in the range of 0.9 to 1.2 billion Swedish kroners. So nevertheless, Camurras ended the third quarter with a healthy financial position, promising outlook for continued growth, profitability, and pipeline progress. With that, I would like to hand over to Richard.

Thank you, Anders. I'll start with the Cameras markets. So net sales for Buvedal in the quarter were 455 million sec, up 8% year on year or 15% at constant exchange rate. Versus Q2, sales were down 3%, primarily due to the economic lower than expected orders in the UK, which also led us to reduce infantry levels. In contrast, underlying in-market sales grew 3% versus Q2 and are 21% year-to-date, driven by maintained growth in Australia, Norway, France and Spain as we continue to execute on our plans, while we saw a flattening of growth in the UK and Germany due to two main factors – In the UK, there are ongoing delays in allocated funding reaching community clinics. However, growth began to accelerate in the criminal justice setting as allocated NHSE funding for long-acting injectable buprenorphine treatment in prisons has become available. In Germany, resistance to uptake remains due to the ongoing remuneration of physicians based on daily visits. Year-to-date in-market growth is positive, around 20% across markets, with the exception of Finland, where growth was single-digit due to the high penetration we have there. There continues to be high demand from patients and physicians for long-acting injectable buprenorphine, and we continue to support this through active programmes that build awareness of the benefits the product brings to patients and wider society. This, in turn, is increasing demand for wider accessibility and is expected to deliver renewed growth in 2026. So on the next slide, I share more detail of our ongoing strategy for improving patient access. We are continuing to grow the real-world evidence base and develop economic models that demonstrate the improved outcomes and the value long-acting buprenorphine brings over daily treatments. The economic models, of which there are some publications on the left-hand side of the slide, clearly demonstrate the positive value of treatment with AIB, typically showing a more than three-time return for governments. These data and models are a critical part of our initiatives to improve access through a government affairs programme that is engaging a wide group of policy stakeholders who will benefit from improved access to these innovative treatment options. As a result of these programmes, we are seeing growing demand in criminal justice settings and the need for the continuity of care on release, alongside support to address funding in community settings. This has already resulted in some success, including allocation and distribution of funding from the criminal justice setting in the UK that I mentioned earlier, and regional funding expansion in France. We also understand good progress is being made on alternative remuneration models in Germany that would address this key hurdle for Buvedal. The success of this activity is critical to expand the use of Buvedal in these markets in 2026. Now, moving across to the US, Brixardi had a strong quarter, as you've already heard, with royalties growing 25% versus previous quarter and 91% year-on-year. Brixardi continues to outgrow the market and has reached an approximate 30% share of the long-acting Bruper Northing segment, which in itself is growing 25% year-on-year and for the first time reached annualized sales of US$1 billion. In the U.S., Brixardi represents a significant opportunity for future growth through penetration of the sublingual buprenorphine market with an estimated 1.8 million patients in treatment and with further potential in the criminal justice setting. Brixardi has a clear and differentiated profile, and Braeburn are successfully navigating the challenges in the OUD treatment market. So overall, we remain optimistic about the prospects for BRICS-RD in the U.S. and the potential for significant growth in the coming years. And on this, I'll hand back to Fredrik.

Thank you, Richard. So let's move over to a quick pipeline update. So starting with the progress of the Octreotide Depot programs for acromegaly, gastroenteropancreatic neuroendocrine tumors, GEPT-NET, and polycystic liver disease, PLD. So as you know and have heard before, we have a large clinical program for CAMP 2029, which represents a major investment and a future potential for cameras. In Acromegaly, we have successfully completed the AcroInnova program, delivering positive results from two pivotal phase three trials, as well as long-term extension study. In GEPNet, we advanced the Sorento trial towards the improved important readout of the primary efficacy results in 2026. Finally, we recently completed the Positano study in PLD, also that with positive results for the primary endpoint. I will start here with an update of the Sorento study in GEPNet. This was recently discussed at a well-attended scientific symposium at the North American Neuroendocrine Tumor Society meeting in Austin, Texas, where it rendered significant attention among the participating physicians and other healthcare providers. The topic of the symposium was dose optimization of somatostatin receptor ligands, which is the efficacy-driving hypothesis behind the Sorento trial. So chair of the symposium was Dr. Jennifer Chan, president of NANETS, and presenter was Simran Singh, University of Toronto, who is the president-elect of NANETS, actually now the president of NANETS. Both are Sorrento Study investigators and steering committee members. The conclusion of this discussion was that there is very high hopes and good prospects for Sorrento and CAM2029, of course, providing positive outcomes. Patient recruitment in Sorrento was started already in Q4 2021, which means that the first enrolled patients have now been in treatment for about four years, in many cases without disease progression. The study was fully recruited at the end of 2023, as all patients have been assessed for about two years or longer. So far, the experiences from the trial are generally very positive in terms of patient feedback and the projections for completing the randomized efficacy part of the trial has been extended based on the lower than predicted rates of progression-free survival events during the past few months. We recently completed a new analysis of the accrual rates in the study, and based on the trends, we have updated the projections for reaching the 194 events for the study to mid or second half of 2026. From a CAM 2029 and study outcomes perspective, the adjustments should be positive while also extending the time to primary results. To put this in perspective, I would like to highlight the study design and patient population that is part of the STORENTO trial. So compared to previous studies of tumor progression, Soremto is a randomized active control study with a primary objective to assess the superiority in progression-free survival for treatment with CAM-2029 versus standard of care with first-generation somatostatin receptor ligands. It is indeed the largest ever study of an SRL performed in patients with neuroendocrine tumor surgery. And a majority, and this is an important point, of the patients in Sorrento has advanced grade 2 or grade 3 neuroendocrine tumors at baseline compared to no or a minor portion of patients in the earlier tumor control trials, PROMED and CLARINET. The progression-free survival for the blinded population in Sorrento should be viewed in the context of the study population, which makes us optimistic about the study prospects. Moving over to PLD, during the quarter, we continued analyzing data from the Positano trial in preparation for an end-of-phase-2 meeting with the FDA planned for early next year. Furthermore, CAM-2029 was granted orphan drug designation for autosomal dominant polycystic kidney disease, ADPKD, both in the US and EU during the period. Pointing to the high unmet medical need in this indication, importantly, this can also expand the future orphan drug exclusivity to PLD arising from ADPKD. So that is significant progress in itself. Finishing off with the Acromegaly indication, Oxyisa has now been granted market authorization for the treatment of Acromegaly in both EU and the UK. For the US, the NDA has been updated during the quarter and is ready for resubmission as soon as we have received green light from an inspection at the contract manufacturer. Please remind yourself that there was nothing in the CRL from the FDA that was related to the product itself or its clinical or safety data. Based on our plans for resubmission, we expect a new PDUFA date and a potential US launch of Oclase in the first half of 2026, which will, of course, be an important event for us. In parallel, we are preparing for launches of Oxys in Europe, the first monthly subcutaneous octreotide medication in the market, enabling convenient self-administration for patients and enhanced octreotide plasma exposure. The European launch has now been initiated in the Wave 1 countries with an estimated 3,000 to 5,000 acromegaly patients currently treated with first-generation long-acting somatostatin receptor ligands. The response to the Oxy-ISA profile from physicians and patients has so far been very encouraging, with a positive view both on this and clinical data. And market research that we have performed in the area show a high willingness to switch to Oxy-ISA from current somatostatin receptor ligands. In addition to this, we have also had positive initial feedback from payers, So as you may have seen from the announcement earlier this week, on Monday, Oxisa has now been launched in Germany as the first country in Europe and globally, and our medical affairs and sales team are now out in the field. Germany represents a substantial opportunity with about 2,000 patients currently in treatment with first-generation somatostatin receptor ligands. and with an annual sales potential of over 50 million euros. A recently performed physician survey suggests that about 30 to 60% of these patients are initially considered suitable for switching to Oxyisa. Obviously, Gepnet represents a much larger opportunity. However, Acromegaly is, of course, a great starting point here. Alongside the advances of the CAMP 2029 program, we have also completed treatment of the last patient in the Phase 1b study of our monthly semaglutide formulation, CAMP 2056, based on our fluid crystal technology. We now expect to provide top-line results this month with focus on tolerability and, of course, importantly, efficacy indicators such as body weight and HbA1c. In addition, we progressed our strategic partnership with Eli Lilly for the development and commercialization of long-acting incretins in the cardiometabolic area. including GLP-1-GIP dual agonists and GLP-1-GIP glucagon triple agonists. And we are naturally very excited about progressing this collaboration. So with this, I think it's time to finish off with some key takeaways of the quarter. In summary, we had a good quarter. As you have heard, not without challenges. However, we did significant advances and progressed and expanded our business, delivering strong profitability and cash flow, stable moving on sales in Europe and Australia. I think our team are doing an excellent job also with regards to the future development in the market. Notably, Brickside had another good quarter in the US, outgrowing the rest of the market. In addition, for Oxuisa and Acromegaly, we received the UK approval. and prepared the launch in Germany. And also, as I mentioned recently here, we advanced our promising long-acting Incrutin pipeline. With this final note, I think it's time now to move over to Q&A. So please, Einar, take over the call.

Thanks, Fredrik. The first question is from Victor Sundberg from Nordea. Please go ahead, Victor. The line is open.

Yes, hi, and thanks for taking my questions. So I had a question first on booby dolls. I just wondered if you could provide any more details when you expect funding to be released to clinics and when the market could turn around in the UK. I mean, I was trying to get a feel for if this could spill over into Q4 as well or into early 2026 or how we should model this impact. Thank you.

Yeah, we'll leave that over to Richard.

Yes, I mean, funding is coming in drips and drabs. There are some areas that are having funding now, others less so. So I can't guess what the government would do, but we hopefully will see some advances in Q4 and then moving into 2026 as well on that. I mean, it is growing, the UK market. We are getting more patients. It's just slower than we anticipated.

Okay, thanks. And also I had a question as you have launched Oxisa now in Germany. Could you comment maybe how it's priced versus the other injectable depot formulations on the market? Thank you.

Yes, I think you could estimate that it's priced at the high end of the Sandostatin reference product. So I think it's the official price now. It's just under 3,000 euros. Yeah, just under 3,000 euros per dose.

Okay, yeah. Okay, thank you very much. That's all for me.

Next. Hello? Hi, Katie. Can you hear me?

Yes, we hear you.

Cool. A couple of questions on my end. The first one is for Bovedal in Europe. How many net patient additions were there in Q3? And are there any additional markets that recently came into play? For example, think of Portugal. They can support a future growth while the issue in UK and Germany persists.

Yes, certainly. I mean, we reported the number of patients, 67,000. But Richard, maybe you can comment on the growth in the additional markets, Spain and... Yes, I mean, everybody's making a contribution.

We grew 2,000 patients between quarters this time. Portugal, yes, is ready to come on. It's early days in that market. So we're waiting to see that.

But yes, they will provide an opportunity for us as we move forward to grow the numbers of patients in treatment.

And we're seeing positive trends also in Spain, where we are seeing big potential. And of course, we have further countries, including the northern European part. Maybe this should also be put into the context of the dynamics of other movements in the Nordic markets and elsewhere. But there is good growth potential there.

Okay, got it. Thank you. And then maybe another one on BrickSat in the US. At last update, I think it was on Q4 last year, the numbers showed roughly 25% market share for BrickSat in the LAI markets. Now it stands at 30%. Is this the market share of new patients switching from sublingual buprenorphine to LAI?

I think, I mean, the main component, and we have talked about that for quite some time, is that most patients are coming from sublingual buprenorphine, of course. And depending on the relative growth in that segment, this will, of course, impact the market share between different products. So I would say the majority of the share is coming straight from sublingual.

Okay. I mean, the reason why I'm asking this is last week Indivio reported a 75% market share. So I'm just wondering on which metric you based this 30% market share.

So we have used several different metrics, we should say, or different data sources, and all of them converge into 30%. And that includes both public sources and also other sources that we have access to.

Okay, thank you very much. That's all for me.

Sorry, the next question is from Richard Romanius from Red Eye. Please go ahead.

Hello, good afternoon. I have two questions on the guidance for this quarter. So I'll just read both questions straight away. In your Q3 report, you guided for around 650 million R&D costs in 2025. And also, this was dropped in the Q3 report. So is this because, as I expect, costs will be lower this year? Is this because you overestimated costs? because some costs would be postponed into 2026. My second question is, you lowered the guidance, should we say, implicitly from Braeburn, since you don't expect the milestone, which I assume is revenue-based. Is that because of stronger U.S. competition or other market dynamics, or both?

Yeah, so shortly, so, you know, we're not pushing costs ahead of us. Of course, there will be something that is a bit delayed, but there's also been a number of savings in the R&D department. We're doing a tech transfer and so on. So it is a gas reduction, and then some of the costs will come into 2026. So it's a mixed situation here, but it will be lower for the year.

Okay, that's good to hear.

Can you repeat? I missed the second question. Sorry for not answering that.

Sure, no problem. Implicitly, you guided for lower revenue from Rayburn since you do not longer assume a milestone payment, which I assume is related to revenues. Is that because of strong US competition or just because of market dynamics?

I think it's mainly market dynamics. I mean, we were expecting... We had, of course, very high expectations on the year and those have come gradually down. But I think the good news is that we have seen very good recovery here, especially now also consistent recovery. But in total, this has led to the... the milestone being at risk, which of course it was not in the early pace of our assessment.

Okay, those were my two questions. Thanks. Thank you.

The next question is from Sean Harmer from Jefferies. Please go ahead. Hello, Sean. I have one question.

I was wondering if you could provide more color on your manufacturing expansion efforts in the US. I know you're planning further investments to deploy U.S. operations for Acromegaly. I'm just wondering what your thinking is for GapNet next year and what your sales force will look like there. Thank you.

Yeah, I mean, in terms of manufacturing, you know, we have talked about that last quarter. All of those processes are advancing. Obviously, we have our current sources, but we have a need to secure future supplies, especially then when Gepnet comes up. So that's an important part of the further development of Gepnet. And that is progressing perfectly according to plans. So that's positive.

And then just maybe one more quickly. I was just wondering if you could share a bit on your future outlook for the Australian market with Buvidal, because now you've reached 80% share, I think, of the LAIB market. Do you think this is reaching a plateau, or do you see future growth here?

Richard? Yes, I mean, Australia continues to grow well. We have about 30 percent share of the total market now, as you said, above 80 percent of the long acting segment. We still see that demand in Australia. We still see it growing. There's a lot of people still on sublingual that are interested in moving across. And of course, methadone is a large segment as well. And we're seeing increasing numbers moving across methadone because the advantages long acting brings. So we anticipate continued growth in Australia.

OK, clear. Thank you.

Now we have Sean Harmer from Jefferies. Please go ahead. Hello, Sean.

Hi there. Thanks. Hi, Fredrik. Just two questions from me. I'll take them one at a time. So on the Sorento readout, obviously we know this has been pushed to sort of late 2026. It makes sense that this is because of the time to accrue events, but are there any concerns that the control arm may be outperforming such as, for example, when Ivo Brutinib's phase three study read out and Obagio surprisingly outperformed?

Well, I mean, you can never come with guarantees on these things. But in terms of, obviously, we are using the literature reference data, We are trying to compensate for populations and population characteristics and so forth. There is nothing new that has happened in terms of the standard of care changing in terms of treatment changes and so forth. So I think we should, you know, this should not be the case, but you can never, you know, be sure 100%. But I think our view is on this is and that's also our physicians input is that, you know, there's not been any material changes into the treatment regimen for the standard of care. So it's about trying to understand the different data sources. And I think we have a good indication.

Understood. Thank you. And then just for my second question, could you just tell us what Brabant communicated with respect to the criminal justice channel and the dynamics that were occurred during 3Q on both state and federal side? And then what would it look like for 4Q?

Well, I mean, that leaves me with... I'm sorry, but because of the... competitive situation, but also because of our contractual situation. I'm not able to go into any details on this note at this moment, Sean. I would, of course, want to, but I cannot fill you in on this.

No, that's fair. Thank you, Fredrik.

Thank you.

The next question from George Tigalono of Bjarke from ABG. Go ahead, George.

Hi, guys. George here. Thank you for taking my questions. I have a couple. So first, I was wondering whether you or Baburn have seen any price pressures for Buvidal or Rick Saadi lately. And secondly, your competitors in DVR, for example, at the Q3 reporting last week, they highlighted that Sublocate has unique offerings. in the long action of this category in terms of rapid induction, i.e. a second monthly dose injection after one week. So, of course, Indira has a history of quite aggressive marketing, so I'm curious if you're able to comment whether or not you think this is an actual significant distinguishing factor versus Bixadi, seeing as Bixadi allows for weekly initiation with the weekly dose injections. Thank you.

Thank you so much. Well, to the first question about price, I don't think we have heard about any price pressure in the US. I mean, it's obviously the whole system has prices, an important, increasingly important component. But I haven't heard of anything specific there or anything that is concerning to us. When it comes to the rapid initiation of With Indivius product, I don't prefer to kind of make judgments versus a colleague in the market here. I think, you know, it probably has some advantages for them. I think we have a very good treatment regimen as it is. We have, you know, the transfer doses from sublingual, which is the most important market, plus we have the weekly doses. So we have all of this under control. It was conducted a big study in emergency centers in the U.S. with over 2,000 patients using the weekly start as a very successful measure to taking over patients from in-hospital treatment to outpatient treatment. And plus it's used very regularly in the system. Do you have any further to say there, Richard?

Yeah, to add to that, I mean, some of the feedback from some of the core research we've seen from various groups is that patients like to start with weekly because they want to understand how it feels to be like a long acting before they commit fully to a monthly treatment.

So I think the patient preference is for a month for a weekly initiation. And our experience in Europe shows that.

I think most, yeah, and most importantly, of course, we still see that we have, I mean, it appears that our partner is doing a good job in the U.S. We're progressing, CAM 2020, I'm so sorry, it's 38, but we're progressing pretty nicely in the U.S. based on our competitive profile, and I think that holds a lot of, advantageous compared to other products in the market. So thank you for the question.

Thanks. And the next question is from Susanna Queckburner from Handelsbanken.

Hello, Susanna Queckburner here, Handelsbanken. I have another question on Bruvidal. So you have your target for 2027 of reaching 100,000 patients. With the last few quarters of 2,000 patients net addition, you need to substantially accelerate to reach that going forward. Perhaps you could comment on how you think about that. And then also, is that possible in the markets that you currently have? Or will you need to address the regions where we've had budget constraints differently?

First, we still retain our vision for 2027, also in regards to the 100,000 patients. Obviously, there are challenges and opportunities. Maybe, Richard, you want to go into your thinking around this?

Yes, I mean, it is not necessarily a linear approach.

As we create successful arguments to increase access, we can see acceleration there. And we've got a number of processes that are ongoing in discussions with various groups that could still bear fruit to that. And our ambition is still achievable. And I think we have to remember that we still have relatively low penetration in this market at about 10% of patients. So there's still plenty of opportunity to grow the business. And we can, if we can resolve the funding issues and the hurdles we faced, which we're on track to do.

And I think adding to that, I mean, obviously we have great teams working in various different, everything from government affairs to, to direct contacts with the medics and so forth. And we generally have a very positive field and, But as Richard says, it will not be a linear curve up to the goal and it will be a lot of hard work. But we retain our vision and we are working hard to achieve it.

Very good. And then a follow up on the Eli Lilly deal. In the initial press release, you didn't mention anything regarding Amelin, but there was opportunity to expand. Can you maybe just give us a little bit more on what progress has been made recently and how you think about other increases?

I can't give you any update because it's outside my remit, so to speak. But yeah, I mean, obviously they have an option to Amelin and usually an option has a time limitation coupled to it. So that's one of the components of our collaboration. which I think you can very nicely say that right now it's progressing very well. But I can't give you any details on that beyond those two comments.

Okay, thank you very much.

Thank you, Susanna. The next one's from Dan Akshuti from Parieto Securities.

Hello, and just one more question. That is regarding 2056 as well. If you can share just some more details of what you're expecting from the data readout this month and what you will be able to share in terms of detail of the data. Will it be just a press release with some top line, or will you share a lot of graphs and details on GKPD, et cetera? Thank you.

Thank you. First of all, I think it's important to know the study design. So basically, the study design is one part, which is a randomized part versus semaglutide. So the monthly versus the weekly. And then there is a second part of the study, which is basically a dose escalation part. So we're going from low to high concentrations or very high concentrations. So obviously, you know, we will report comparative data focusing on the, obviously, tolerability profile is important, weight and PD readouts in terms of HbA1c and so forth. So the traditional measures, it will most likely be, you know, provided in a press release form with some data points. key data points. And then later on, we'll likely follow up with more detailed information about the product results. So I think that's the order of them. But what is unique with this study is, of course, that we have an active comparator. I think it's not that usually that you go into a Phase 1b study with an active comparator. So it will be an interesting read out from the study with, I think, clear potential to demonstrate something of relevance. That's how far I can.

Thank you very much.

We have a follow-up from Sean Harmer from Jefferies as well.

Hi again, Sean.

Hey, just one more from me really quickly. Can we expect CAM 2056 to be press released this month, then? And could you just speak to how detailed that release will be? I know it's only phase one, but any sort of colour would help. Thank you.

Yeah, I mean, absolutely. Our intention is, according to the current timelines and so forth, our intention is to be able to press release it this month. And the data, I mean, we will... I think you can anticipate... about the same level of detail as you see from other pharmaceutical companies working in the space for a phase one B trial or early phase two trial. So I think that you should expect that level of detail approximately.

Thanks so much.

Yeah, thank you.

There are no more questions at this time. So I hand the word back to you, Fredrik Anders and Richard for closing comments.

Okay, thank you so much. And I just want to say, of course, we thank you very much for joining into this call. It's a pleasure to have interest from you all and engaging questions. And I look forward to meeting you all on the road or at our next call in Q4, the Q4 report. And with that said, thank you again, and we can close the call.