I'm Shan Hama. I'm from the European Pharma and Biotech team at Jefferies. I'm delighted to have here with me today Fredrik Tiberg, CEO of Camurus, and Behshad Sheldon, the President of U.S. Operations of Camurus. Firstly, I think it'd be great to kick off with an introduction of Camurus.
Oh, thank you. Thank you. Great to be here, everybody. Camurus is a Swedish-based company focused on the development of long-acting medications for treatment of chronic and severe disease. In the commercial stage, we have two products for treatment of opioid dependence that we no doubt will discuss today, a broad pipeline of more than 10 clinical programs from phase I up to registration. We have a very interesting platform technology called FluidCrystal, which is basically the engine behind a lot of the things that we are doing in the development stage at Camurus.
Thank you very much for that. Let's kick off with actually your most recent development. You signed a deal with Eli Lilly yesterday for your FluidCrystal technology, specifically in cardiometabolic health indications. Could you just expand on this and perhaps the rationale for the deal and what FluidCrystal could bring to Eli Lilly?
I think that's for Eli Lilly to rationalize on. I think the deal was that we have a number of compounds that have been included for exclusivity in the area of metabolic, or actually, the area is not defined, but we are working with different compounds, including GIP GLP-1s, GIP GLP-1s plus glucagon. Amylin is included in this transaction. Of course, it's about the development of up to four compounds. It is quite an extensive program, significant economics, important potential in terms of future royalties. That is the basis. Of course, it is a great validation for Camurus' development and our FluidCrystal technology as well.
Thank you for that. Let's move on to Brixadi. This is your long-acting injectable for the treatment of opioid use disorder, commercialized by your partner Braeburn in the U.S. Could you outline the current treatment paradigm for opioid use disorder and then also the medical need for a treatment like Brixadi?
Oh, yeah, please. The current treatment paradigm for opioid use disorder is basically daily sublingual medications with buprenorphine combined with counseling, so daily medications, or methadone, less so in the U.S. There is, of course, a number of limitations with these treatment systems. One is that you often have issues with patients not following treatment, so compliance is a problem. Relapse into opioid use is another. Also, stigma is something that can be addressed with new, more convenient treatment options. We have misuse by patients, which is a potential risk. With our long-acting injectable treatments, we are addressing a lot of these kind of key medical unmet needs.
Can you comment on what's driving the majority of Brixadi uptake? Is it new starts or switches? Is it switches from oral buprenorphine, or are you also seeing switches from Sublocade, maybe?
If we're looking at where patients—I would say about 85% of patients are switched from a previous treatment. A large majority of them come from oral buprenorphine or sublingual buprenorphine, I should say, probably around 80% of that nature. The rest come from other long-acting injectable treatments. In terms of new starts, I would say it's around 15% of the patients entering treatment.
Brilliant. You previously commented that the largest channel for Brixadi is Medicaid, but you derive a portion of your sales from the criminal justice system in the U.S. During Q1, Brixadi sales, thus royalties, were affected by a weaker U.S. buprenorphine market. Could you explain these dynamics to us, please? How should we think about the market over the next few quarters? Are these headwinds temporary?
First of all, we have disclosed that the majority or the largest single segment of our, or the largest single channel for Camurus in terms of sales is coming from Medicaid. After that comes commercial. We also have a component of federal from the federal channel. That is important. The commercial channel is growing in importance as we speak. In terms of, I think maybe, Behshad, you can comment on the other questions, the follow-ups.
Yeah. In terms of Medicaid headwinds, every time you change something in the system, of course, it ends up delaying people. There were these waivers that states had in not having to ask for renewals to be happening subsequent to people actually reapplying for Medicaid. That expired last year. This first quarter has been a little bit tricky from that standpoint. I think once people realize that that system is back in play, it is going to ease out. I think we have seen probably most of the impact. Of course, none of us have a crystal ball about what is going to happen with Medicaid broadly. I do think that both the potential cuts and the work requirements and all of those things have—a lot of people are talking about them, but there is a lot to be worked out.
We will see whether the impact will be as significant as people might think. Already, 2/3 of people who receive Medicaid assistance either work or have disability, which then means they do not have to work necessarily or cannot. You are left with 1/3. We will see how that pans out. We still have to take these bills through the next episodes in the Senate and then maybe back to the House. We shall see.
I think it's important to know also that the medical need is certainly there. We have 6 million people in the U.S. in need for treatment. Only 2 million are currently receiving any sort of treatment. The medical need situation is unaffected largely. I think what we are seeing is that CMS and others are investing into new treatment, let's say, improving the access to treatment for opioid use disorder. This is something that is being prioritized both on the state level and nationally, I would say.
Brilliant. If we just look at peak sales, the last estimate we have is of over $1 billion. It looks to be underpinned by a penetration of the U.S. buprenorphine treatment population limited to 5%-6%, which is well below what is seen for Buvidal ex-U.S. Is it fair to say this is a conservative assumption?
I mean, I think our view is that it is a conservative assumption in terms of penetration. The potential is significantly larger. Of course, that does not mean that the potential will be fully realized. I mean, that is up to the actors in the space, including our partner, Braeburn Pharmaceuticals, which is commercializing the product in the U.S. Definitely, I mean, in Europe, in the Nordics, for instance, we have market shares from 30% to 70%. In Australia, well over 25% of the overall patient population and 80% of the long-acting injectable population. With those types of numbers in the U.S., of course, it would be well in excess of $1 billion.
Okay. Makes sense. If we look at methadone patients, is Brixadi currently being used in methadone patients? What's the opportunity here? What's the ease of putting a methadone patient on Brixadi versus potentially on Sublocade?
If you're seeing Europe and Australia, there is an increasing interest in transferring patients from methadone because the results, the treatment results are better. There is also a dynamic that a lot of patients want to leave daily medication, supervised medication, and move over to something that is much more easy from a quality of life standpoint and less burdensome. That is, of course, a monthly injection. We are definitely seeing that dynamic, and it's increasing across our geographies. In the U.S., the scenario is slightly different. There are approximately 400,000 patients in the U.S. that are actually receiving methadone treatment at treatment clinics. We know that there are a lot of those patients that want to transfer to a different treatment paradigm. I think that process is undergoing, but it's in relatively small numbers, with significant potential long term.
Makes sense. If we shift on to Buvidal, so this is Brixadi's brand name ex-U.S. You did mention sort of very high penetration rates in markets like Australia, the Nordics. Do you think you've reached peak penetration in some of these regions, or do you foresee more room to grow?
I think we are foreseeing more room to grow, basically, across all geographies. Our extreme case is still Finland, where we have up to towards 70% of all patients. We are continuing to see growth because due to the event of long-acting injectables coming into the market, more patients have actually come into treatment and chosen to be treated. There is a significant potential there. We believe in Australia, for instance, that we could, in good circumstances, exceed 50% of patients with long-acting injectable treatments. There is very significant potential. In Europe, there are also big markets like the U.K., Germany, and Central Europe, where we currently hold high single-digit market share. There is a very significant growth potential. The main challenge for us across all geographies is to allocate and make sure that financing is allocated to treatment of these patients.
Brilliant. Your aim is to treat 100,000 patients by 2027. The latest figure in Q1 states that you're at 63,000 patients, which is a 3,000 increase from the previous quarter. How should we be thinking about the ramp to 100,000, and what regions and factors will drive that patient uptake?
Yeah. Our aim is to treat as many patients as possible or give availability to effective treatment for as many patients as possible. That is definitely the case. Our vision for 2027 is 100,000 patients. We think that is readily achievable by looking at the current growth trajectory. On top of that, adding entries into the larger markets like the U.K., Germany, where there is significantly higher potential of growth. That is where we are setting a lot of our focus. Methadone patients constitute almost 60% of the European patients. That is also a growth opportunity, which we are investing more into, the transfer from methadone treatment over to long-acting injectable. Beyond that, just this year, we had four new countries that were receiving reimbursement and pricing.
Those will also contribute, as are new markets that we are expecting to see over the next few years.
Thanks for that. Opioid use disorder is a particularly pressing issue in the Middle East and North Africa, particularly in regions like Bahrain and Kuwait, albeit sort of less flagged. Could you highlight your efforts in MENA, particularly with your partner, NewBridge?
Yeah. We're working towards improving access to treatment for opioid dependence. Obviously, this is a big problem in the Middle East. Egypt is said to have more than 1 million patients or people dependent on opioids. It's a huge problem in Iran and Iraq. Currently, most of our sales are in the Gulf region. We had an approval as the first treatment for opioid use disorder, opioid dependence in Saudi Arabia, actually. There, NewBridge is working to build up the treatment system and improve access to treatment for opioid use disorder patients. There's a lot of activities going on. We also have approval in other markets. We will see probably three or four new markets receiving regulatory approvals over the next two to three years.
Thank you. Super helpful. Now let's switch to CAM2029, Oczyesa. It's been on the mind of many, many investors. This is your long-acting octreotide. So last year, your third-party manufacturer received a complete response letter from FDA in acromegaly, meaning that, obviously, the approval was delayed. You're currently awaiting this evaluation inspection report, which will enable you to refile. What's your confidence in Oczyesa's approval following this resubmission, which I believe should be at the end of 2Q?
Yeah. I mean, I think it's important to say that when we received the CRL, we had late-stage labeling discussions. We had agreement with the FDA on all those points. We didn't have any questions about the product, CMC, clinical safety. Basically, once these manufacturing issues at the third-party manufacturer are resolved, there shouldn't be any outstanding issues. There shouldn't be any clinical risk or CMC risk in this. This is also kind of confirmed by the positive opinion that we recently received from the European CHMP, which confirmed. We are expecting now to have European approval over the next few weeks. That's very positive.
Brilliant. What about commercial readiness? Is the infrastructure in place for Camurus in the U.S.?
I mean, absolutely. Behshad, you can comment on that.
Yeah. All the functional areas are staffed up. A lot of work has been going on in terms of KOL development, market shaping, disease awareness, increasing awareness of Camurus, as well as working with payers to set up for ultimately having a faster uptake. We stop at the point of actually hiring sales reps. I believe in doing contingent offers and then actually hiring people when you have FDA approval. We have the methodology to scale very quickly from that point. Just ready for the product to be approved.
Brilliant. How do you view the competitive environment within acromegaly? What are your thoughts on Crinetics' oral drug and that potentially entering the market?
Yeah. First of all, I think at this moment, we are waiting for two new product entries. That could be Camurus, CAM2029 or Oczyesa, as you mentioned. Also, Crinetics have a submission in the U.S. ongoing or a regulatory review for paltusotine. That is two interesting new treatments. I'm a very big proponent of getting new treatments to market. I think it is good both for building the market and, of course, key for patients. I think we have a strong position. At least our research suggests that CAM2029, with both once-monthly dosing and simple self-administration with a pen injector, is a very attractive treatment option for patients with acromegaly. I believe we have a strong position in the market once approved. We will see that first in Europe.
Brilliant. Just on the European opportunity, could you perhaps talk through differences or similarities between the physicians, the prescribers in acromegaly? Is there an advantage, perhaps, of being able to launch in Europe first before the U.S.?
I think it's an advantage to being able to launch in every market first. Certainly, Europe is an interesting market for neuroendocrine disease. I mean, it's a little bit more challenging market because it's fragmented, has a different pricing pressure. Also, patients, once they have access, you avoid all the issues with pre-authorizations, et cetera. You typically have higher retention in treatment. Once you are at the market, there's a clear and high potential. The number of patients is higher in Europe than in the U.S. We are expecting this to be a fruitful venture once we are just launched.
Yeah. You previously stated that the large opportunity for CAM2029 is in GEP-NET. The phase III study is due to read out early 2026. How many events do you need to accumulate before reading out? What's the bar to be here?
Yeah. We are doing probably the largest, or it is the largest, study in GEP-NET patients with the somatostatin analog so far. Very interesting study. We recruited 332 patients. The study is powered to demonstrate superiority with the hazard ratio of 0.65. For that, we estimate that we will need 194 events. Once we have those 194 events, we will stop and read out the primary endpoint and, of course, continue to look at overall survival.
Brilliant.
We are expecting that to happen somewhere from the very end of this year to the early part of 2026.
OK. Understood. Interestingly enough, if we look at your pipeline, you have CAM2056, which is your,
Maybe I should just comment that also we have CAM2029 is also in development for polycystic liver disease.
Yes. Correct.
Which is a disease which currently has no treatment available. We are expecting results from our phase II-B or phase II/III study over the course of the next few weeks. That is also an interesting development going on in the company.
Yeah. Definitely. Yeah. On CAM2056, this is your long-acting semaglutide, currently in a phase I study for overweight and obesity. What gives you confidence in this program? Is there anything else in your pipeline you want to highlight that we have not discussed?
I mean, if we're looking at the program that we're currently performing with semaglutide, it's, of course, based on a number of preclinical data points, including everything from pharmacokinetics, pharmacodynamics, weight loss, et cetera. There is a significant package behind our clinical program. The clinical study is comparing CAM2056, which is the monthly formulation, with Wegovy, which is, of course, the currently commercially available weekly treatment. We have one part which is randomized and comparing it to the labeled initiation regimen for Wegovy versus our dose escalation regimen. We feel, based on the preclinical data, we feel quite confident that this will deliver interesting results. The study has been ongoing for three and a half months now. We have some feeling for how the outcome is. So far, it looks very good.
We will look at both pharmacokinetics, weight loss, and other readouts, including glucose and so forth, traditional readouts for GLP-1.
That's readout second half of this year, is that right?
We're expecting results, yeah, sometime second half of this year. So it will be exciting for us.
Sounds good. Let's shift to BD. You've been quite open about actively working on M&A. What sort of company would you look to sort of bring into Camurus or even portfolio of drugs or one particular drug? What's your ideal profile?
Yeah. We have disclosed that we are looking mainly for commercial stage assets or pre-commercial stage assets, which are synergistic to our current commercial infrastructure or commercial products pipeline as well. That is our target overall. We are looking in the endocrine area, associated rare disease areas, as well as CNS complementary to our development with Buvidal and Brixadi, of course. From a regional perspective, we are interested in both U.S., European, and even with our Australian presence, we could look at pseudo-global rights. We are currently looking at a number of different targets, both assets and companies. Hopefully, that will result in something interesting over the course of this year or next year, who knows?
We're eagerly await. Given several late-stage studies in your pipeline, as well as Oczyesa potentially coming into the market in Europe and the U.S., how should we be thinking about R&D spend, SG&A over the coming years?
For R&D spend, we have been quite clear that we do not expect any increase this year because we have some clinical programs that are now coming to the end. We have had two successful studies in acromegaly. The last patient in the extension trial was just completed. We are expecting to have basically stable costs in the R&D side. SG&A, we will see some incremental increases, mainly related to our U.S. organization. I think it is relatively stable, I would say, over the year to come.
OK. Now for the topic on the mind of many investors and has been for quite a few months now. What's your thoughts on the recently announced most favored nation pricing? What's Brixadi's exposure here? And how would potential tariffs on Brixadi affect you? Does Braeburn ship Brixadi to the U.S. themselves?
I mean, if we start with the most favored nation, I think I do not have anything to bring there beyond what all the experts and oracles have. What we know is that it will take time for this to be implemented. That is for sure. When it comes—what was your second question there?
Just on how would potential tariffs affect Brixadi?
Oh, yeah. When it comes to tariffs, we do not see any effect at all because our U.S. supply is coming from the U.S. We have very little in terms of other cost structures or manufacturing-related cost structures. European sales and European manufacturing is in Europe. We are completely free from those type of risks at this moment.
OK. Understood. Then just finally, your four-year guide implies, if I'm not mistaken, around 40%-50% growth on your top line versus 2024, which is obviously quite significant. Despite a, I guess, arguably weaker 1Q with several market-related headwinds, what drives confidence in achieving your guide?
Yeah. So I mean, basically, as you know, we did a transaction yesterday, which is going to support our strides forward financially. We have a very aggressive outlook for this year. I think we're quite confident that we will be able to manage that. I mean, we're talking about doubling our EBIT and increasing our growth to between SEK 2.7 billion-SEK 3 billion, which is a growth of around 50%. Yeah, that's still maintained with confidence.
Great. Are there any questions from the audience?
Yes, please.
Did you share—sorry. Did you share the data from your semaglutide trial with Lilly ahead of the business development?
I cannot comment on that. I would, of course, like to, but it's not part of—I cannot say anything.
Any other questions?
With some of the recent funding headline on Medicaid and criminal justice, how have you seen that impacting Brixadi, especially in the U.S.?
I mean, we saw in the first quarter that there was a significant impact on Brixadi sales, as we noted in our quarterly report. We also refer to the—we do see some coming back of growth. It is too early to say how the year will end. We are one step away from the kind of market data. We do believe that this will turn, and we will see a stronger rest of the year. It was definitely not only for our product, but if you look at related products, for instance, Vivitrol from Alkermes, it dropped very significantly first quarter. It is something that we see across the board, actually. We believe that it will change as the dynamics in terms of financing are changing.
Brilliant. Any more questions? Thank you so much.
Oh, we are on the second.
Yeah. Exactly. Thank you so much.
Thank you so much.