Welcome to Day Two of the Jefferies London Healthcare Conference. I'm Shan Hama from the European Pharma and Biotech team here at Jefferies. I am very happy to have with us today the CEO of Camurus, Fredrik Tiberg. Fredrik, would you like to kick off with some introductory remarks?
Of course. First of all, welcome to this session here in the morning. I'm representing Camurus. We are a Swedish-based pharmaceutical company focused on treatment of long-acting treatments of rare and chronic disease. We have a very interesting profile. We are profitable since 2022, driving forward our opioid use disorder products in Europe and with our partner in the US, and also having an interesting development with new product approvals in acromegaly and also targeting a neuroendocrine tumor indication later on this, or at least from a study perspective, later on this year, and plenty of other interesting things in the early pipeline. It is a mix of exciting research and development and profitable growth.
Thanks so much for that. Let's kick off in a bit of an unconventional way with one of your pipeline assets. You shared pretty standout data from your phase I-B study of your once-monthly semaglutide, CAM2056, which was head-to-head versus Wegovy. Could you speak a bit more about the profile of CAM2056 and what that looked like compared to Wegovy in the study?
Yeah. We are developing a once-monthly formulation of semaglutide, and we studied this formulation. It is based on our FluidCrystal technology, which enables then a different pharmacokinetic profile. This was quite an exciting development. We did a head-to-head study against Wegovy. Wegovy dosed according to label for five months and studied the CAM2056 product for three months at different doses, including also dose escalation. What surprised us perhaps was that we could go up to very high initiation doses with maintained tolerability. Basically, that is due to the profile of the product from the PK perspective. We also saw very strong efficacy indication in terms of weight loss and A1C reduction in these patients. The patients had a BMI from 27-39.9 or so, that type of population, but were otherwise healthy.
Maybe I should just show the data that we got from. This is the study design. The first part was a randomized part where we used two dose strengths of CAM2056 versus semaglutide in the form of the current weekly product, Wegovy. Then, based on the results from this session, we also dose escalated into 2x . Basically, throughout these different doses, we had good tolerability, except for the highest initiation dose of 5 mg, which is about 20 x higher than Wegovy's dosed in the first dose. It is a very high dose where we had some tolerability issues in terms of GI effects. What perhaps was most interesting in this trial was looking at the response in terms of weight reduction, as you can see here, and also A1C reduction across the three months that we studied the product.
You can see that we had a very hefty response, strong reduction in both parameters, and also for glucose. It was a very positive outcome, good tolerability, and a positive indicator for our other developments in the incretin space.
Brilliant. What's the strategy around this program, and what's your thinking for the phase II-B in terms of the number of patients, the sites, and the titration regimen?
In terms of the titration regimen, we have already identified our dosing strategy, which was very positive in this study outcome. In terms of the study, of course, we would study for longer duration. That's an important part. We only had safety data for a three-month initial run, so we would go up to longer duration. I'm not going to go into the details of the study because the results are very updated and new, and I think it's more appropriate to take that at a later stage. We will update. We are also considering increasing, going to even higher doses than we have done in the phase I-B study.
Understood. When and where can we expect the full data from the study?
We will communicate that appropriately, but I would say mid next year or in the mid to early part of next year.
Got it. You also signed a significant partnership with Eli Lilly for up to four programs relating to sort of cardiometabolic health. Could you expand on the rationale of this deal and how that sits alongside CAM2056?
I think this is a very exciting area, the whole cardiometabolic space. We have a strong technology platform. We want to use that effectively for the benefit of patients. Therefore, we both have a strategic partnership now with Lilly and are able to pursue our own interests in the GLP-1 area with semaglutide and potentially other compounds as well. It gives us a good mix and a good presence in an exciting indication area.
Understood. Now let's move on to Brixadi. This is your long-acting injectable buprenorphine for the treatment of opioid use disorder. It's commercialized by your partner, Braeburn, in the US. Could you perhaps speak a little bit about this asset and the royalties you receive and the commercial potential?
Yeah. I mean, Brixadi is a very interesting product. It's a weekly and monthly long-acting injectable. There are two durations for treatment of opioid use disorder, which, of course, everybody knows is a huge problem across the world, but maybe especially in the U.S. with the fentanyl crisis still being affecting people across the board. We have developed this product. It's now being commercialized by our partner, Braeburn Pharmaceuticals, in the U.S., which have delivered, I think, best-in-class launch across the board. We see good uptake of the product. It's still a small segment of the overall opioid use disorder market, but we're seeing good traction across the space there.
Understood. I know the U.S. criminal justice system has sort of been in focus this year, given some of the funding headwinds, particularly on the federal side. Could you speak a bit about those dynamics and why drugs like Brixadi are so sensitive to this funding?
I think we had a special situation at the end of 2024 because the federal part of the criminal justice system imposed some restrictions on long-acting injectables because basically they were too well adopted. That was an issue that we had crossing over from Q4 last year to Q1 this year. Fortunately, the states have been picking up. We have good traction in the state prison system, which is about 80% of the overall market in the U.S. This is an interesting system with very special dynamics where the institutions have overall cost responsibility and efficiency responsibility. There our product is demonstrating very good adoption and strong interest for prescriptions and prescribing.
Brilliant. Thanks for that. Given all of these sort of headwinds this year, what's your outlook for the criminal justice system in Q4? Have you seen any signals into 2026 that you could give us some color on?
I think headwinds is probably not the right word. I think it's more that we had a tough start of the year, but it's picked up very nicely both in Q2 and Q3. We are expecting that to continue. I mean, SAMHSA has financing of about $1.5 billion for these state opioid programs, and we will see that coming into 2026. There's also a lot of positive dynamics across the board in the market, so I don't expect anything else than a good continued growth in Q4 in the CGS system and also in the commercial setting.
Got it. During your 3Q results, you provided an updated long-acting injectable buprenorphine market share of 30% for Brixadi. Are you able to tell us potentially where you see this getting to at peak?
I think the most important part in terms of currently the opioid use disorder treatment market is dominated by daily medications. It has approximately 92% of the total market share, about 1.8 million people in treatment. This is a huge opportunity to leverage, and our focus is there. On the other side, of course, long-acting injectables is a place where we are competing. We have seen growth up to 30% now in two years, which is a rapid penetration. Fortunately, I believe that this will continue to grow. Our main aim, and I think the one of, is to convert patients from daily sublingual treatment, which is coupled to a lot of limitations and also issues, including diversion and also risks of relapse and so forth. We are pushing that direction, and that's where we see the big growth opportunity in the U.S.
Understood. Now moving on to Buvidal. This is Buvidal's brand name ex U.S. For lack of a better term, we saw a slowdown in growth in 3Q. Could you touch on the causes of this and sort of your outlook going forward?
Yeah. I mean, it's a complicated market, but it's also a very interesting market where we are dependent to a certain extent on government financing. We had a topic in the U.K., still continuing, where the state or the government funding was not reaching out to the clinics, especially not the outpatient treatment clinics. That restricted what was in Q1 and Q2 a very positive growing market. Unfortunately, that happens. It's been slow in terms of pickup. We see now that money is coming into the system, especially in the criminal justice system in the U.K. We are having dialogues with all stakeholders. We have a huge interest across the board, both from the criminal justice system, but also the community treatment systems in having Buvidal implemented more widely.
There is an explicit statement from the U.K. government that they want to see long-acting injectables reaching 25% share, which we are very far from. I think the growth opportunity is very exciting. Of course, it is always working with governments. It is not the easiest thing in life, but it is a fun thing if you like those types of challenges.
Got it. Buvidal has been on the market, obviously notably longer than Brixadi. In regions such as Australia and the Nordics, you have very, very high market share. Where do you see the greatest opportunity for continued penetration?
Yeah, fortunately, I mean, in Australia, I think we have become essentially standard of care with about 35% long-acting injectable penetration and where Buvidal has over 80% of that part. What is exciting there is we continue to see growth. I believe we can potentially reach up to 50% of the Australian market based on the properties of the product, of course, and the advantages that this brings to patients. Australia is an interesting system for opioid use disorder treatment because they have, I would say, they have been ahead essentially of all other nations in terms of the development of that market. It is a good indicator for the properties of the product and the potential we have. We see that also in the criminal justice system where we have essentially up to 80% of that market segment as well. We believe we can continue to grow from 35% long-acting share to maybe 50% and above, especially penetrating the methadone market segment.
Got it. Thanks so much for that. Let's switch to your long-acting octreotide CAM2029, otherwise known as Octase. What is the latest on the plans to resubmit the acromegaly NDA to FDA? Where does that place potential approval?
Yeah. With regards to our long-acting octreotide, we got approvals in Europe and the U.K. over the summer. We have a delay due to a CRL in the U.S., and that's relating solely to the manufacturer. The manufacturer is completing its corrective measures right now. It should have been done a little earlier, but those things happen. We are expecting to resubmit quickly this part of the year and have an approval decision during H1 next year. That's moving forward. In the meantime, we're launching the product in Germany as well as in multiple other European markets and following other exciting developments.
Great. How do you view the competitive landscape for acromegaly, particularly in light of sort of recent approvals?
I mean, acromegaly is an established market segment. The big problem in acromegaly for patients, one of the big problems is that essentially all patients need to go to a treatment clinic to get administered their injections, either intramuscularly or subcutaneously in some cases, but for lanreotide. That is a big issue. Also, there is a limited efficacy for many patients, so those in combination. I think we have the ideal product candidate because it is once monthly, it is a well-established regimen. Octreotide is very well trusted, safe, and established. We are bringing this in a much better product form where we are using a simple autoinjector, very much like what you see for the current incretins, and patients can administer themselves. We have much higher drug exposure, which also has the potential of improving symptoms. We have seen that in our phase III trials. I think it's a very competitive product profile.
Brilliant. You touched on it just a while ago in terms of launch in Germany. Could you speak to, I know it's still very early, but could you speak to the early launch dynamics and sort of physician feedback you're getting on Octase?
Yeah. Interestingly enough, the main feedback we had before launch was, "When is the product available?" That was the, which I think is a positive indicator. We got good response both from, and of course, we had patients in Germany that were in our phase III trial, both ACROINNOVA 1 and ACROINNOVA 2. We already got the first orders in. Of course, this is a small market, but there seems to be good dynamics and a large interest from prescribers. We will see how the pickup comes, but the early signals are very positive.
Good to hear. I think a lot of people know that the significant opportunity is actually in the get-net population. You have the phase III SORENTO study, which was pushed out to sort of mid to late 2026. Given it's a head-to-head study versus standard of care, how should we interpret that delay? What's the best way to look at it?
I mean, the whole point of the treatment here is to delay, if you put it that way, progression-free survival and overall survival as well, as long as possible. In a way, you can say those types of timeline changes, if anything, they should be positive because they indicate that despite the fact that we have a patient population in our trial, in SORENTO, that is more advanced in disease with both the largest portion being grade 2 patients and also having some grade 3 patients, we seem to deliver very competitive PFS outcomes in terms of what we see now. The issue is always when you're doing a study like this is that the studies are blinded. Of course, there could be a surprise. You can never in the wrong direction, but there is no indication why that should be.
I mean, standard of care is not developed over the past 10 years. So we understand that patient population quite well. I see it overall from an efficacy standpoint, we see it as a positive indicator. Plus, our patients and also the feedback we get from physicians is very positive. We're getting very good signals, high patient satisfaction. Hopefully that's a strong indicator.
Got it. What's the minimum treatment benefit required for statistical significance and your confidence in achieving this bar?
Yeah. We powered the trial for a hazard ratio of 0.65, so a 35% treatment difference. However, if you take it from the other direction, we think that we could get statistically and clinically significant results already at 25% treatment difference. We feel, based on all the work we have done, of course, from analyzing previous data sets from phase II and phase III trials and also literature data, we feel quite confident that we can achieve that.
Got it. Let's shift to business development. You've been quite open about sort of working actively in sort of looking at M&A opportunities. If the time did come where you wanted to sort of do some BD, what's the ideal company profile and what firepower do you have to execute?
Yeah. I mean, we have built successful commercial infrastructure from basically Australia to Europe and now also establishing in the U.S. Our primary interest from an M&A standpoint is commercial or pre-commercial assets that have, which I say, a target audience which is suitable for our current commercial capabilities. It could be in CNS, endocrinology, niche oncology. We are very active. We have a team here, of course, very active, focusing on trying to obtain assets that are suitable and synergistic to our current developments.
Perfect. During your 3Q results, I mean, we have to talk about the downgrade to your 2025 outlook to sort of below the bottom end of your initial outlook. What drove such a big move?
We had a combination of things. I've already talked about the U.K., so that contributed. The overall development in the U.S. due to the early dynamics, we had the overall dynamic was that we had to readjust our revenue guidance while we have been able to accommodate that adjustment. We are still maintaining our profit guidance of SEK 1 billion for the year. That's SEK 0.9-SEK 1.2 billion. We are extremely disciplined and we're continuing that development. On the positive side, we're also seeing the U.S. picking up in terms of Brixadi sales and new products coming in. I think we'll continue to deliver good growth going forward.
Great. Without obviously giving an official guide for 2026, sort of looking into the future, how should we think about it sort of more qualitatively in terms of what the top line could look like and what profits could look like?
I mean, top line will continue to be driven by market penetration in the opioid use disorder area, but also with our new products. Of course, we are having very high expectations for the net indication. In addition to that, we have a number of partnerships, so there are additional opportunities in terms of royalty revenues, milestones, etc. I think we have a good mix, relatively low risk, but also some significant large upsides.
Got it. Brilliant. I think we have a minute or two if anyone wants to ask a question.
Any questions?
No. Okay. Maybe I'll just ask you about the Braeburn milestone then. Are you able to tell us how big the total milestone is? Are you able to give us details on the tranches of the milestone related to Brixadi?
No. I mean, essentially, I can't give you any indication, but I mean, total milestones, we have now $75 million left from our partner. And they are divided into three tranches, and all of them are at relatively low threshold levels. We were expecting this to be well within our margin. It may come, it may not, but it's of that. If you take $75 million divided by 3 and then you think about incremental growth, you could probably figure something out.
Makes sense. Thank you so much, Frederik. Do you have any closing remarks?
No, no. I would just say thank you for coming and listening to Camurus. It's a pleasure to have you here.