Camurus AB

During the questions and answer session, participants on the telco are able to ask questions by dialing pound key five on the telephone keypad. Now I will hand the conference over to CEO Fredrik Thibald. Please go ahead.

Thank you so much and good day everyone and welcome to Canberra's second quarter 2026 result call. Thank you for joining us. Before we begin, please take note of our forward-looking statements which apply throughout today's presentation. Turning to the agenda, we will start with highlights, moving over to financial and commercial performance reviews, before finishing with a short R&D pipeline update, key takeaways, and then of course Q&A. With me on the call today are Anders Wadsholt, our Chief Financial Officer, and Richard Jameson, our Chief Commercial Officer. So let me start with some highlights. I'm very pleased to report a solid second quarter, marking a clear return to growth after a softer start of the year for cameras. Total revenues were 702 million SEK, up 4% year-on-year and 32% sequentially, with an operating result of 293 million SEK, corresponding to a 42% margin and finishing with 4.1 billion SEK in cash. Commercially, product sales reached a record of 528 million SEK. It's the first time we are above half a billion in a quarter. Buvidal grew 12% year-on-year and 24% over the quarter. Bixadi royalties in the U.S. increased 42%, and the OxyVisa launch continued in our first wave European markets. In the pipeline, we received a complete response letter for the acromegaly NDA in the U.S. in June, which I will cover and come back to later in the presentation. Elsewhere, Sorrento continued to progressing towards its primary analysis. We advanced CAM 2056 phase 2b preparations. Lilly expanded our collaboration by exercising its option to include amylin receptor agonists. And with that, Anders will now take over and go through the financials.

Thank you, Frederik. The financial figures clearly demonstrate strengths, which is encouraging. Looking beyond the headline numbers presented by Frederik, if we strip up the one-off milestones, our underlying product and royalty revenue has grown from around 445 million in Q2 2024 to 559 million last year and now reaching 655 million this quarter. This reflects a compound annual growth rate of around 21%, with bubidyls showing stable growth and Briggs hydrology is almost tripling as Braeburn scales in the U.S. Over the two-year period, marketing distribution expenses rose from 108 to 175 million, reflecting our expanding commercial operations and sales growth. At the same time, R&D costs declined from 172 million to 125 million following the completion of multiple trials, signaling a favorable change in our cost structure as we shift towards a commercial execution. Administrative costs have increased to support the higher level of activity. Regarding profitability, the operational results reached 293 million this quarter, up from 292 million last year. Although year-on-year figures appear similar, they conceal an improvement. Last year's figure included a significant milestone of 150 million, whereas this year's milestone was 46 million. The core margin is clearly improving. Earnings per share were 4.05 Swedish kronor. Our cash position at the end of the quarter was 4.1 billion up from around 3.9 billion at the start, reflecting a rise of approximately 190 million. The primary factor for the net cash flow came from the operating activities, which comes to be $338 million before working capital adjustments. This was primarily partially offset by $104 million outflow in working capital, mainly due to the higher trade receivables and increased inventory to support the growing demand for OXISA, along with $41 million invested primarily to set up a second manufacturer. Importantly, we remain debt-free, which gives us real flexibility as we look ahead. Regarding capital allocation for the rest of 2026, our main priorities are clear. To finance the organic growth of the business, including commercial expansion and pipeline development while maintaining a strong and flexible balance sheet to support partnerships and business opportunities as they emerge. On the cost side, we initially allocated additional 200 million to expand our commercial activities, particularly for the U.S. team to support the upcoming of Glaze launch and to prepare for CAM 2029 in JEPNET. Furthermore, we intend to invest additional 150 million R&D for the planned new clinical trials. These investments will be funded from our own cash flow. Despite the CRL, we have reaffirmed our four-year guidance. And with that, I'll hand over to Richard for the commercial update.

Thanks, Anders. So I'll start with Bovedal. In Q2, Bovedal delivered a record quarter with net sales of 524 million sec. This is up 12% year on year and 24% sequentially. In-market sales were up 19% versus the same period last year and 6% quarter on quarter, which reflects strong underlying demand. Growth was broad-based across geographies, including the Nordics, Germany, Spain and France, and UK saw improving sales as new NHS funding starts to become available. Australia was steady, with prescribing capacity in parts of the market a limiting factor that we're addressing with clinics and providers. Boverdale remains the clear leader there, with over 80% of the LAIB segment and an overall market share of patients above 30%. In Australia, at the end of the quarter, it was announced that the other long-acting buprenorphine product is being withdrawn from the market by the end of 2026. The product has a minority share of the long-acting injectable buprenorphine segment, and our priority in this regard will be to ensure continuity of care for patients working with clinics as we've done in similar transitions in Sweden, Finland, and Germany. We ended the quarter with an estimated 77,000 patients in treatment, up a net 4,000, and we're on track towards the 100,000 patient ambition by the end of 2027. Now turning to the US. Brixardi continued to grow well in the US. Royalty revenue rose 42% year-on-year to 127 million sec. That was up 20% sequentially. That makes it a record royalty quarter and a clear re-acceleration after the seasonal softness we saw in the first quarter. Demand was solid across office-based care, treatment centers, and correctional facilities. Importantly, this growth is happening in an expanding market. The U.S. long injectable segment is now estimated to be around $1.2 billion on an annualized basis and growing more than 30% year on year. Yet it still represents about only 10% of the roughly 2 million patients treated for opioid dependence with buprenorphine. That leaves substantial room for conversion to long-acting therapy. Within this segment, we estimate Brixardi, based on preliminary company data and adjusting for pathology, now holds about 30% of equivalent units. Braeburn has made significant investment in its U.S. organization this quarter, too, expanding both the commercial field force and medical affairs to support that growth. Taken together, an expanding market, growing share, and increased investment behind the brand, we see substantial further growth potential for Brixardi in the U.S. Now moving across to Oxasia. In Germany, the launch continued, according to Plan, with 4 million sex cells in the quarter and very positive patient and physician feedback. Our focus for the second half is broadening adoption and moving towards a double-digit share of acromegaly patients on somatostatin receptor and agonists. The commercial capabilities we're building here are also helping prepare the ground for CAM 2029 in GetMep. The rollout is also extending beyond Germany. Oxazer is now available in Sweden with a first patient treated and with a September launch meeting. And formally processes are progressing in the UK with the first outcomes expected later in the year. So on this note, I'll hand back to Fredrik.

Thank you, Richard. And let me first turn then to the pipeline where CAMP 2029 remains the central near-term value driver for us. So CAM2029 is a broad opportunity built around a long-acting octreotide with potential across acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease. The key point is that this is not a single indication asset. It's a drug compound and delivery platform with multiple clinically validated opportunities. In acromegaly, the ACRI-NOVA3 program is completed. and it's being communicated at various medical conferences and elsewhere. Oxyisa is approved in the UK and EU, and the European launch is underway. In the US, the FDA issued a complete response letter for Oclase in June. Importantly, this relates to observations during a previous GMP manufacturing inspection at a third-party site. and not to the efficacy or safety or otherwise for CAM 2029. Those observations have now been addressed and a new PDUFA target action date is the next important regulatory milestone for the programme. Our view of the clinical profile and commercial opportunity for CAM 2029 remains unchanged. Our largest near-term opportunity though is gastroenteropancreatic neuroendocrine tumors, a substantial and growing market with considerable unmet medical needs. Sorento is the largest randomized study of a somatostatin receptor ligand in GEPNET to date and is our most important pipeline catalyst this year. The study has been fully enrolled since the end of 2023 and based on current event accrual, we expect to reach the target of 194 progression-free survival events in the fourth quarter, followed by the readout of primary results. A positive outcome for CAM29 in NET would support the compound as a new first-line treatment option, opening a very meaningful new growth avenue for cameras. Finally, in polycystic liver disease, the positive Positano Phase II results were presented and recognized at this year's EASL conference in Barcelona, a leading hepatology event. We hold orphan drug designations in the US and EU for PLD and ADPKD and have completed the FDA end of phase two meeting this year. And the extension study is currently ongoing, which together with the feedback will form the basis for the decision around the continued phase three program. Beyond CAM 2029, our earlier stage pipeline gives us additional exposure to large therapeutic areas while allowing us to leverage the same long-acting delivery experience that underpins our commercial portfolio. CAM 2056 is our once monthly semaglutide depot based on the fluid crystal technology. During the quarter, we completed a type B meeting with the FDA and the regulatory submission package for the Phase 2B clinical trial has been prepared. The study remains on track to start in the second half of the year, building on the positive Phase 1B data report in November. Product design work is also ongoing in parallel, including the validation of an auto-injector pen to support simple once-monthly dosing. We see a meaningful opportunity for once monthly incretin therapies overall, particularly given the adherence challenge seen for current weekly and daily treatments. Our collaboration with Eli Lilly is progressing to plan. During the quarter, Lilly exercised its option to include amylin agonists and expanding the scope of the partnerships beyond the dual and triple incretin agonists that we had already started. We view this as a further external validation of the fluid crystal technology and its potential in the long-acting metabolic medicine space. With Gubra, we have selected the lead compound for our long-acting parathyroid hormone and analog program and are advancing into further development. Taken together, these programs provide several independent opportunities to create value across large and underserved therapeutic areas, supporting supported by our own development capabilities and two well-resourced partners. Let me close with some brief quarterly summary and priorities ahead. Our strategy rests on four clear priorities. First, commercial execution, extending our leadership in the opioid dependence area with Buvidal and Brixadi. and advancing the OXISA launch in Europe, strengthening the readiness and broadening the CAMP 2029 commercial efforts. Second, advancing our pipeline with multiple near-term catalysts, the Sorrento readout in Gepnet, the start of the CAMP 2056 phase 2b, and the US resubmission pathway for Oclays, alongside progress in the broader portfolio. Third, partnerships and business development. We are progressing our collaborations with Lilly and Gubra, and we remain active in evaluating opportunities that can broaden our pipeline and add long-term value for the company. And fourth, financial strength. We have been sustainably profitable since 2022 and ended the quarter with 4.1 billion in net cash, giving us the means to invest behind our launches, pipeline, business development opportunities, while maintaining strategic flexibility. The second quarter showed our model is working with record product sales, strong profitability, disciplined investment and a robust balance sheet. We now enter a catalyst rich second half with clear priorities, commercial execution, pipeline advancement and selective capital deployment. With strong momentum across the business, we are well positioned to continue creating value for patients and of course, also for shareholders. Einar, with that said, we are ready for the first question.

Thanks, Fredrik. The first question is from Gonzalo Atiak from Danske Bank. Please go ahead, Gonzalo, your line is open.

Hi, thank you very much for taking my questions and congrats on the good quarter. And my first question is on Bovidal. You mentioned in the report strong performance in Nordics, Germany, Spain and France. Just to get some clarity here, is the growth this quarter in any part driven by stocking in any of these regions that we should account for future estimates? And how should we look at these regions forward? And I'll continue with another question after.

Okay, I'll leave it to Richard to respond.

No, it was underlying demand. The growth was broad, as we said, across the countries. You mentioned Nordics, Germany, Spain and France, and all considered, alongside UK, growing as well. There were no one-off effects in the quarter.

Great, thank you very much. One question on Q3. I mean, Q3 tends to not be the best quarter for Bovidal in Europe due to the holiday season. How much are you guys expecting this to affect Q3? Is the second half of this year especially back-end loaded in your estimate or how should we see this?

I think it's difficult to give any predictions about Q3. We don't expect to see, I mean, generally speaking, we have seen in the past years, we have seen relatively okay Q3 developments. And I think it's too early for us to give any other indications.

OK, perfect. One last question. It's on the CRL in the US. Could you clarify what is the status of the contract manufacturer you are setting in the US right now? And I know you cannot give much details right now, but what would be the reasons to remain in the contract manufacturer you have in Europe on the back of the two CRLs you have gotten and not moving straight to the US line with your other partners there? Thank you so much.

Well, I think that, to be frank, our current manufacturer has been capable and able to deliver. Unfortunately, we have this CRL, so that's something we are accounting for. But strategically, we have decided to build out and make sure that we are not sitting with one single manufacturing unit. Okay. So we need to have broader capabilities, and that's the reason. But I don't think we can say anything further on that. If you're looking at the commercial supply performance and also the regulatory discussions with other authorities, we have not seen any issues with current supply.

Great. Thank you very much.

The next question is from Romy O'Connor from the Landshut campus. Please go ahead, Romy.

Yes. Hi, this is Zoe on for Romy. Thank you so much for taking our questions. So I have two questions. You noted that the outstanding FDA comments have been addressed and that a further regulatory update is expected soon for the OKLAS US approval. Can you maybe help us understand what still needs to happen before this resubmission and if you still think this is going to be a 2026 resubmission or if it's more likely for 2027?

So from our standpoint, the remediations have been completed and that means remediations in relation to the CRL we received on the 10th of June this year. As you know, these were, as we said, third-party related. On the other hand, there was a small point also on this oxygen scavenger, and that has been also addressed. So we are hopeful that we will have a resubmission confirmation as soon as possible, but we are not giving any further details at this moment. But I think 2026 is clearly an opportunity.

Okay, thank you so much. And my second question is, are you able to outline the differences between the two CRLs that you received?

Not really, because I mean, essentially, they were very similar in the sense that there had not been an inspection. and therefore you can say that the earlier remained. So that's the situation. We believe the manufacturer has been in contact with the agency and we believe that this communication and also provided inspection readiness declaration So we are expecting the agency, and most likely we'll do an inspection at some point.

Okay.

But it's obviously FDA on the table of FDA and not us.

Yes, I understand. Okay, thank you so much.

Next question is from Sean Harmer from Jeffery's. Please go ahead, Sean.

Thanks so much for taking my questions. I've got three if I may. Just to continue on the OCLE CRL, has the manufacturer communicated that they expect an inspection to definitely happen this time round? Or is that still uncertain?

I would say that considering circumstances, it's highly likely that there will be an inspection of the manufacturer.

Understood. And then my second question, please. Is there a ballpark figure you could provide us with on the size of the Braeburn sales force in the US and what kind of commercial investments are being made there?

Well, I think not aside from what we have said earlier, I can say that they have made a significant addition to both its commercial customer-facing sales force and medical in the last quarter. And they are, on a size-wise, they are currently on pair with other companies in the space.

Understood. And then my final question, if I may. At what point during the year will you get sort of further visibility into supply for Buvidal to the UK? As in, should we be expecting an acceleration in the second half of this year based on your current visibility?

I think, as Richard said, I mean, I think we have right now we have a process where we have a lot of contributors that behind our growth and we are expecting the UK to develop in a positive direction. I mean, it's difficult to give you any direct indications of when, but we are already seeing some positive trends. So overall, we think that that will be helpful. And obviously, there are also other discussions and processes ongoing. So we will see how it evolves. But so far, it's looking positive. And I think the most important thing is that we see stable growth across European markets at this point, as Richard already alluded to.

Thanks so much.

Next question from Philip Wiberg from Pareto Securities. Please go ahead, Philip.

Hi, good afternoon. I've got a couple of questions on Australia here, where you seem to have had a bit of a cautious tone in the report. So firstly, just on the competitor here that we're drawing towards the end of this year. So we now have an 80% market share, approximately. Do you anticipate capturing those last 20% fairly quickly during 2027? Or how should we think about the dynamics there? Or do you think some patients will switch back to oral, for instance?

Well, I think it's important with continuity of care and we are doing what we can on the medical side to make sure that we assist in any necessary transfers. And what we have seen in previous transfers in the Nordics, for instance, it's been largely, you know, most patients have been transferring over to Bovidal and it's gone according to our reports very swiftly. So if we see the same trend as we have seen in the European countries, it should be a vast majority, and it's happened in reasonably short notice. So I would say that, yes, shortly after the supply is out in end of 26, there should be a transition secured.

Okay, okay, very good. And then just on the overall long-acting market in Australia as well. I think you stated you have 31% share of all patients now on buprenorphine in Australia. And you previously talked about a possibility of reaching about 50%. So are you still feeling confident about that? And can you talk a little bit about what specifically needs to change for the market to expand to that level?

I mean, I can start and leave it over to Richard. I think that, I mean, the 50% is what we have seen is somewhere. I mean, that's a scenario in the future, so to speak. But we see definitely, we already have, you know, over 30%. And adding in the patients is about 36% of patients now currently standing on long-acting injectable. So it's been a very successful entry into the market. Richard, do you want to

No, I mean, Australia is still growing. I mean, even without the opportunity with the other long acting with being withdrawn. So it's still growing. There are some capacity issues in the market. It's about patients accessing treatment per se. But we're working very closely with the clinics. We're doing a lot of programs, for example, pharmacy injection, which relieves capacity in the clinics because patients then can go to the pharmacy and have their injection and move on. And that's been a successful program in a number of states. And we're rolling that out further as well now.

And maybe I should add to that also that in Australia, there's still about 40% of patients that are being treated with methadone. And we're seeing an increasing flux of patients from methadone over to buprenorphine. So that is another positive source of potential growth and patients in the future.

Okay, thanks. And perhaps lastly, just related to that, you stated year-to-date growth in Australia was 6%, so is it reasonable to expect that, you know, staying in the single digits due to these capacity constraints in the near term, or do you see, like, you could penetrate the market and accelerate the growth back to double digits, for instance?

I think we'll update on that in Q3.

Okay, thanks. That's all from me.

Next question from Christopher Ude from SCB. Please go ahead, Christopher.

Christopher Ude, thank you very much for taking my questions. My first one is on your SG&A. It was up sharply as was expected, I guess, ahead of presumptive U.S. launch of OCLAZE, but that's, of course, now been delayed, and at the same time, You know that you've beefed up your Australian sales force. And obviously, you're busy rolling out AXIASA in the EU. So how should we model the cadence of SG&A over the remainder of 26 and into 27? And consensus is modeling a 30% year-on-year increase in 27 to 30% of sales. Are you comfortable with consensus SG&A expectations? That's my first question.

Yeah, so Anders here. So what we saw in the first half, just to see it from our side, is that we prepared for the launch, of course, and then we had an increase also across the globe. So half of the increase in SG&A came from the U.S. and half from the rest of the world. So it's a balance. Of course, there were some upfront investments in the U.S. that, of course, depend on when we will have potential approval, when we will hire the sales force. But I think it's fine, the assumptions you have. One comment I could make, especially on the R&D, is on the R&D cost for the Q2, there were some capitalization of some products because now we have launched in agro-mechanically. So that is... has offset some of the costs we would normally take and then capitalise. It's around 20 million we've taken in the Q2 numbers for the R&D.

Okay, thank you very much. And then, so you've said Indivior, of course, has about 20% share and obviously plans to be out of Australia. So should we just assume a 25% ramp for you between now and year end, or should it be from year end? Just a clarification there. And then how much of your ex-Europe sales of Buvidal are actually from Australia, if you wouldn't mind sharing that.

On the first note, I think it's difficult to make any assumptions at this point because this is recent news. But obviously there is somewhere around 4,000 to 5,000 patients that are currently standing on the other long-acting injectable product. And they will reasonably be transferred across the time over the time until the product is fully withdrawn in the market. So I think based on that, I think it's anybody's guess, but I think that's the fundamentals here. Unless something, you know, surprising happens that I cannot, but I have difficulty being more precise than that. And Richard, the follow-up question there. you remind me the question was x Europe sales what proportion is Australia I think maybe I can say we're not really comfortable going in taking that right right now because it varies very much from quarter to quarter okay thanks Australia is a very very important market from for us as you can see thank you if I could just ask

One more question. It would be on the Phase 2b SEMA trial. Can you tell us now about the design and particularly the size, duration, and dose levels, please?

We will give an update as soon as we have that approved and on track. And that should probably come relatively shortly. So we will update on this.

Thank you very much.

Thank you. It will be a placebo-controlled trial this time. Thanks very much.

Next question is from George Tygalon of Bjarke from ABG Sandal Collier. Please go ahead, George.

Hello, this is George from ABG. Thank you for taking my questions. I have two, please. So first, regarding Sorento, can you clarify if also the announcement of the initial data can be expected in Q4? And then secondly, Mona, if you've seen any recent net price changes for Guvedal or Brixhadi?

So when it comes to the first question on Sorrento, I think... Oh, timing. Yeah. Yeah. No, no. Timing of results vis-a-vis timing of reaching the events. So obviously it will depend on when we reach the target number of events. So if that comes earlier in the quarter, we might have delivery of results in the quarter. If it comes later, there may be a gap, of course, between reaching the number of events and reading out full data.

Yeah, you can do. On the pricing, one of Bouvedan and Brixardi, they're pretty stable. There is, of course, a country mix that comes into play depending on the volumes in each country, but generally in the market, the prices are very stable.

Okay, great. Thank you. There are no more questions at this time, so I hand the word back to you for closing comments. Okay, thank you everyone for attending the call.

It was pleasant as always and wishing you all a continued nice summer. Speak next time at Q3 or earlier.