Hello.
Hi.
Hello, and welcome to day two of the Jefferies London Healthcare Conference. I'm Brian Balch, Jefferies Biopharma analyst. It's my pleasure to have with me here today, CEO of Camurus, Fredrik Tiberg. Fredrik, thanks for being here.
Thank you so much, Brian. Great to be here.
Good to hear. So maybe we can just kick off with a high-level overview of just how the business is shaping up post the third quarter raise to guide on top line and profit before tax. So just how are things tracking, I guess, there as it relates to your 2027 targets? Maybe just key things to be thinking about as we head into 2025.
Yeah, great. No, I think we're tracking very well according to our timeline or our vision for 2027. We've done very good progress in the year, both particularly, I would say, financially and building the business. So we are tracking against our targets. We just raised our guidance, as you noted. And we're talking about next year. I mean, next year, it's too early to come with any guidance here. It's February time. But looking at expenses, revenues, of course, will grow. And looking at expenses, we expect to stabilize on the R&D investment side. But the OPEX overall will grow with the business, I would say.
Got it. Yeah, because your OPEX for 2024 is SEK 1.3 billion. I think R&D is around 600.
Yeah, that's correct, so we will see probably investments in R&D will stabilize, and then we will see some growth because we are launching in the U.S., hopefully, quite soon.
Super. Maybe on to Buvidal, which is ex-US. It's your OUD, long-acting. We're currently at 56,000 treated patients as of the third quarter, slightly impacted by the holiday season. So can you just talk a little bit about that? Because I know your 2027 guidance is to treat 100,000, I believe. So maybe just talk about the kind of journey to that.
Yeah, I mean, Buvidal has been growing nicely during the year. We did currency-corrected, so to speak, 6% growth in Q3 and 6% in Q2, actually, as well. So we continue to grow nicely. Looking forward, we need to accelerate growth slightly. And we see that coming from the large countries in Europe, primarily UK, Germany, France, and Spain, where we have a lot of activities ongoing to drive the uptake of Buvidal. We have a lot of enthusiasm among treatment providers, patients, and a lot of positive media as well. But what we have to turn that into is, of course, further patient uptake. We have the methadone group of patients, which is a very large part of the patient population in Europe, where we are putting more emphasis on switching methadone patients over to Buvidal. And we see a good response overall.
Aside from that, I mean, we'll continue market penetration in current markets. Australia is doing great. We are seeing good progress also in the Nordics, despite having been on the market now for five years there. So I think it's a sum of these different individual contributions that will take us to our target of 100,000 patients in 2027.
Got it. And there's a potential 750,000, right? And is that excluding the methadone?
Yeah, I mean, put it in context. We're talking about a market share in Europe of about 15%-20%. The 750,000 patients include actually Australia. The total treatable population, or the total population with the opioid use-related problems that warrant treatment, is about 1.4 million. I think, I mean, looking further, I see the possibility of actually continuing to grow beyond 2027, of course, and into the '30s, I would say.
Great. Maybe on to Brixadi, which is, again, your opioid use disorder, long-acting, but in the US. So again, I think if you could just talk a little bit about the key growth drivers for that. I believe at the third quarter, you said 70% of those patients are now coming from sublingual buprenorphine and 30% are from Indivior's Sublocade. So you could just talk a little bit about that and the commercial opportunity.
Yeah, I mean, the commercial opportunity in the U.S., if you say the low-hanging fruit, if you can put it in that way, of course, is patients who are standing on sublingual buprenorphine and who can be switched to long-acting treatment, and that's around 1.8 million patients. So it's a big patient population and with a big opportunity for us and other companies in this space, of course. What we were very happy with and seeing last quarter was that primarily growth was coming from this segment, and there was less coming from switches from other long-acting injectables, so this points to the fact that the market is growing and that there is a significant potential for us to continue to grow and accelerate growth over time or for our partner, I should say, but for Brixadi to become a significant product in the space.
Super. And I think you said before that you only need to penetrate 6%-7% of that 1.8 million to achieve greater than $1 billion sales. Is that correct?
Yeah, I mean, you could say our goal is or our outset is to exceed one or that Brixadi should exceed $1 billion in sales, and this is, of course, mutual with our partner, and that with current pricing, it corresponds to approximately 6%-7% market penetration. So it's still a very low rate.
Yeah. And then I guess similar.
It's highly reasonable.
No, it is. Yeah, it is. I mean, and then I guess similarly to Buvidal, you'd be looking to target the methadone patients as well. So that's potential upside, I guess, as well, right?
Yes. I mean, I think you can see, I mean, in the U.S., it's about 400,000 patients that are standing on ethadone.
Right.
methadone treatment in the U.S. is burdensome. It's also limited to certain treatment centers. So you will have naturally some attrition and switch over. But I don't think that that is going to be the target focus. I mean, the focus will be the large sublingual patient population group.
Got it, and you won a criminal justice system contract in California over the summer.
I just have to clarify. Our partner won.
Your partner, yeah, sorry.
Won the contract, yeah. And it's been disclosed by one of our, what's to say, other relations in this area. So yeah.
Got it. Thanks. Can you just talk about when we should expect potential uplift from that? And maybe just help the audience and myself with kind of the dynamics of the criminal justice system because it's something I think that's a bit obscure.
Yeah. I mean, if you first look at the market opportunity in the U.S., I think there's around 2 million incarcerated people in the U.S. today, and of those, somewhere around 20% have an opioid use disorder, so it's a significant market of around 400,000 patients approximately, I would say. In terms of the market dynamics in this segment, one of the things to keep in mind is, of course, that once a contract has been established, there is an implementation period, and these are complex systems, so you typically need time to implement the treatment paradigm, to train the physicians at the treatment clinics, etc., so it doesn't come at once, and I would say, from my understanding and talking to people in this area, it would take six to nine months approximately to get implementation done, and then you come into the actual, what's to say, growth phase.
From our experiences in other markets, like in Australia, where we had very significant success in the criminal justice system, both in the private setting and sales can come very quickly once established, but you really need to go through that initiation phase. We don't expect that a win will convert into revenues within the first six months at least.
Got it. Okay, so more of a 25.
Yeah.
And then maybe if you could just discuss the potential impact of recent government changes in the U.S.
Yeah, that's an interesting discussion. I mean, overall, there seems to be some turmoil ongoing right now, I mean, in terms of expectations. And I don't know if anybody really knows what is coming. But I think what we have seen from the previous term was a commitment to treatment of opioid dependence by the government. So there were clear actions taken as well. And so I think in the opioid dependence area, which is, of course, a very significant problem in the U.S., I think there is a large possibility and also that there will be positive actions taken.
Also some of the other stakeholders here in the transition, including the vice president and also now or RFK, whatever it is going to, we don't know whether they are going to be appointed at this point, but I think they have a clear positive view on treatment of opioid dependence. So in that sense, I think it can be a positive development.
Got it. Maybe on to CAM2029 or octreotide, given that's the bigger opportunity that that's targeting acromegaly, GEP-NET, and PLD. You recently received a Complete Response Letter from the FDA back in October. I think that was due to GMP issues at a third-party manufacturing facility. But then you swiftly submitted responses to the FDA. So we've got an outcome that's due in December. So can you just talk a little bit about that and what the potential scenarios are?
Okay. Yeah, I mean, that's the beauty of this job, isn't it, in the pharma sector, is that you have some bumps in the road sometimes, and this was one of those, hopefully, of course, but no, I think the situation was that we had a PDUFA date in October, and we had really good progress with the agency on all topics, so clinical safety, efficacy, everything was very well received by the agency, and we had labeling discussions up to the very end of that process, but we did receive a CRL, and that was related to an inspection of our third-party manufacturer. The problem with the inspection was that it was very closely in time to the actual PDUFA date, so there was no possibility for the manufacturer within the time stipulated timelines by the FDA to respond to.
You have a 15-day first response, and then I think it's a 60-day response in these processes. What we are waiting for now is the inspection classification. When the agency is having a GMP inspection, it issues an inspection classification, and that has to be issued within 90 days of completed inspection, so to speak. Once we get that, our expectation is that we can refile. Then we are expecting also that it would be a two-month review or Class 1 review period, which potentially would allow us then to have an approval already in first quarter next year. Should there be something outside our expectations, it may be a Class 2. Then it's a six-month review and would be more something falling out towards the summer next year. Obviously, there are possibilities for surprises, but this is our kind of guiding.
In our launch preparations with the U.S., we are making sure we are ready and have all things in gear for the Q1 possibility.
Super. So your base case is Class 1 review in December, two-month review time for a potential approval in the first quarter 2025. And in terms of the opportunity, I think you said before acromegaly is globally 450 million. Is it 400 million?
I think if you look at the global opportunity across all markets, I think, I mean, if you're looking at the US opportunity, it's more like our peak sales estimates are more like 150-250 in that range. It is the smallest of the three indications that we're pursuing with CAM2029 and also the first, but it's a very good entry indication for us. That's the principle.
Super. Maybe on to CAM2029, but in GEP-NET. So that's the bigger opportunity. We've got phase 3 study. It was supposed to read out first half of 2025. You announced in the third quarter that was pushed out. So it's now late 2025 or early 2026. Can you talk about why and how we should be interpreting that?
Yeah. Well, I can talk about how I am interpreting it. And then you will choose how you will see it. But so we have, I mean, the gastroenteropancreatic neuroendocrine tumor opportunities is our absolutely, I mean, short term, the biggest opportunity for our continued growth and transformation as a company. We are expecting it to be a kind of $2 billion opportunity in US dollars. And in this study is, of course, critical in that because we are conducting a superiority-powered study to demonstrate increased progression-free survival with CAM2029 compared to standard of care. So that's the goal of the study. So progression-free survival is naturally also the readout that we are following. And when we designed the study, of course, we looked at all the trials that were conducted with standard of care previously.
We looked at patient-matched populations to the population we have in the SORENTO trial. Through that, we got some expectations for what the overall progression-free survival would be. However, what we have seen now is that you can say that we have fewer attrition or events or fewer than expected. The rate is lower than expected. That means the progression-free survival estimate is longer than expected. We have kind of tuned then our expectation for completing the trial from first half of next year to end of 2025 or beginning of 2026 based on those. We think that's a good sign because obviously we have read out all the data support for the comparator. We know what that is in different patient groups. We have quite an advanced disease population.
We have a majority of patients being grade two, having grade two neuroendocrine tumors, and also some grade three. So it's a much more advanced disease than, for instance, used in the CLARINET study by Ipsen. Still, our progression-free survival times seem to be competitive, if you put it that way, for the overall population. However, it is still a blinded data set. So this is our interpretation that it's pointing in the positive direction, but that remains to be proven.
Got it. So just to clarify, you need 194 events.
Yes, that's correct.
Correct. Because.
Or the study is powered to 194 events, yeah.
Got it. Because one interpretation is your drug is doing a lot better and therefore the comparator arm needs more events.
Yes.
Okay, interesting. Okay. And then just on your confidence on that 35%, because the feedback is that seems like quite a high bar, just 35% superior.
Yes. So basically, we modeled this study or we modeled the data based on literature data, published and non-published, and also data from the Novartis study RADIANT-2, and based on the dose response assessments that were done in that study and then simulating that to exposure that we have established for CAM2029, we came up with a hazard ratio of 0.55. We took a more conservative approach with a 0.65 hazard ratio, and that's basically the outset for our powering of the trial. We have also looked at what would happen if we would have, say, only a 25% improvement versus standard of care, and we believe or our data and simulations support the positive result also for a 0.75 hazard ratio or 25% improvement.
Got it. So you're confident in 35%. The delay is not a bad thing necessarily.
It's always bad with the delay because we will not have the product on the market at the same timeframe. But from a result standpoint, and I haven't lost any confidence in our view by that, no.
That's very clear. Okay. So we spoke about acromegaly, 400-450, GEP-NETs around $2 billion. So the third piece is really PLD, polycystic liver disease. And I think phase two, three expected in the first half of 2025. Can you talk a little bit about that?
Yeah. So we had the study fully recruited in, I believe, February last year, end of February. So we have 72 patients included. They are randomized to either treatment with CAM2029 or placebo, two groups of CAM2029. And the ambition is to then show the impact of the drug treatment on height-adjusted liver volume and symptoms in this group, which currently doesn't have any treatment available to them. So that's the pursuit. This is not a truly pivotal study in the sense that it's a phase two slash three, and it's not going to lead to an, it's not provable in the U.S Potentially in Europe, we haven't come to a conclusion. So we will have to do a second study. But the results will come out probably early part of Q2 next year or at least during Q2 next year.
Super. And just to clarify, there's no approved therapy in that space.
There is no approved therapy to these patient groups, so there is a significant need for improved treatments here.
Got it. And then the peak sales opportunity that you estimate is?
It's somewhere between acromegaly and neuroendocrine tumors. So what I would say are 500 million approximately in that range.
Got it. So potentially close to $3 billion globally for all three. Okay. Then maybe onto your GLP-1 long-acting CAM2056. I think plans are still to initiate end of the year.
Yeah. We have submitted the study protocol. Of course, it has to go through ethics, etc. So we will not have the first patient treated because you have Christmas and New Year's and so forth. So we will probably initiate patient treatment. Once we have the protocol approved or the CTA approved, we'll initiate the first patient probably after New Year. It's going to be a randomized study looking at our once-monthly GLP-1 candidate, looking at PK pharmacokinetics, so plasma concentrations over time. We'll look at tolerability. We'll look at weight reduction because we are working with patients who either have an obesity disorder or are obese or overweight, but are otherwise healthy. So it's really a healthy volunteer population.
Got it.
So that's the primary. And then we have a number of pharmacodynamic readouts. And we will also compare data to the current approved weekly weight management treatment based on semaglutide.
Super. So I guess an update from that is more like 2026?
No. I think this study could, we could probably report data out already in the second half of 2025.
Got it. And then I realize we don't have much time.
At least top-line data, I should say.
Okay. Maybe one on potential M&A in licensing. Can you just share your thoughts on that?
Yeah. We have said that. I mean, we have a focus. Of course, our focus is on organic growth, and we have a lot of growth drivers, but we have also, since the capital raise we did when we strengthened our balance sheet, we have also opened up for the opportunity to do M&A or licensing deals. We're focused on late-stage, preferably commercial assets in areas that are synergistic to CAM2029, for instance, and as well as our opioid dependency and SUD kind of interests. We're progressing, having a lot of discussions, of course, a lot of evaluations ongoing. But we are not, we are opportunistic, and we are not going to force ourselves into something that we don't believe in 100% or at least 95%. But this is an ongoing process, and hopefully we'll report something out on that note next year or so.
Super. With that, well, that's it from me. So thank you very much for that informative discussion, and thank you to the audience.
Thank you, Brian.
Thank you for.