Camurus AB (publ)

Thank you so much, Einar, and good day, everyone, and welcome to Camuri's full year and fourth quarter earnings call. Before starting, please note our forward-looking statements. So we will begin the presentation today with the short business highlights, then review the financial performance, followed by commercial and R&D updates. And of course, then Q&A. As previously, I'm joined in the call by John Garay, CFO and Richard Jameson, Chief Commercial Officer. Camerus had a rewarding 2024 with good performances across the business. This resulted in high growth and profitability alongside advances of key pipeline programs. In parallel, we continued the geographic expansion with the establishment of Camerus Inc. in the U.S., Importantly, we remain on track to deliver our five-year vision of five-fold revenue growth from 2022 and an approximate 50% operating margin in 2027. As a reflection of the solid performance during the year, we delivered continued strong operating revenue growth, as well as you can see on the right-hand side here, sustainable high profitability. Our fourth quarter results exceeded previous estimates with Bovidal growing at double digit rate in owned territories and Brixari finishing the first full year with strong fourth quarter. Additionally, we established a fully operational U.S. commercial organization as prepared for the launch of Oaklace in Acromegaly. On the development side, regulatory reviews of CHEM 2029 continued in the US and the EU, with a temporary setback in the US in the form of a complete response letter from the FDA relating to an inspection of a third-party manufacturing facility. I will come back to this later in the presentation. In parallel with the regulatory reviews, our clinical studies Sorrento and Positano continue to advance And before the new year, we initiated a new clinical study of our once monthly semaglutide GLP-1 product. On the corporate side, we delivered solid financial performance, positioning the company for further expansion and growth in 2025. And with this short introduction, I'll leave the word over to John for a financial update.

Thanks a lot, Fredrik, and good afternoon, everyone. During the quarter, Camurus continued its development, delivering strong growth and financial performance. Now, I would like to share the key financial highlights of this quarter. At the end of the quarter, Camurus achieved 553 million SEG total revenue, delivering a growth of 48% versus same period last year, with product sales of 469 million SEG growing 28% versus prior year and 11% versus prior quarter. Additionally, Bricsaddy sales in the United States represented an 83 million SEG royalty income, growing 43% versus prior quarter. Looking at full year results, Camurus reached 1,868 million SEG total revenue, representing a growth of 9% versus prior year. Excluding one-time revenues in 2023 related to Brixa the approval in the US by FDA, total revenue grew 42% versus prior year, and Brixa the royalty represented 212 million SEK. During 2024, the company achieved an earning per share after dilution of 7.20 Swedish kronor, equivalent to a profit after tax of 429 million SEK. And company cash position progressed positively, ending at 2.85 billion. Moving to next slide, we can see the main components of our profit before taxes. Company gross margin reached 94% in the quarter, representing an improvement of 267 basic points versus same period prior year, driven by three major factors. Firstly, supply chain efficiencies, driven by Boogitar volumes scale-up, represented 181 basic points. Secondly, 96 basic points are driven by Bricsady royalty. And thirdly, FX represented a negative impact of 10 basic points. Total OPEX reached 357 million SEC, representing a 4% decrease versus same period prior year, driven by following factors. Marketing and distribution investment to support market penetration in own territories. Expansion of Woobidal into new markets and US operations grew 40% to 157 million SEC. Administrative expenses aligned with corporate evolution to substantiate company development grew 48% versus same period last year to 25 million SEK. R&D investment reached 167 million SEK, decreasing 27% versus same period prior year, driven by lower social security costs related to long-term safety plans and lower study costs in our clinical trials. On a full year basis, R&D investment reached 684 million SEC, equivalent to 37% of total company revenue. During the quarter, the company explored a potential transaction incurring in one-time expenses of 8 million SEC regarding advisory fees that are reported in other operating expense lines. Company profit before taxes reached 186 million SEC, growing 204 million SEC versus Q4 23. On a full year basis, company profit before taxes reached 553 million SEK, which excluding one-time master revenue impact represents an improvement by 409 million SEK, increasing 286% versus 2023. Company cash position at quarter end was 2.85 billion SEK. Camurus improved its cash position by 101 million SEK during the quarter, driven by following four factors. Firstly, company operations generated 166 million SEK. Secondly, third window of ESOP 21-24 program generated 18 million SEK. Thirdly, working capital consumed 63 million SEK. And fourthly, investing activities required 20 million SEK. At the end of quarter, Camurus has no debt. Moving now to 2025 guidance, company has considered the following factors when providing 2025 financial guidance. Market conditions, the current microeconomic environment, continued investments aligned with the strategic vision 2027, in which we imply R&D will continue approximately flat in the level of 0.65 billion sec, and incremental investment of approximately 0.35 billion sec to fully deploy U.S. operation, launch workplace globally, and support company growth. Social security costs regarding company long-term safety programs will vary with the share evolution. And from a capital expenditure point of view, company will invest about 0.2 billion SEC in the next two years to develop a second manufacturer to enhance manufacturing capabilities and support new product launches. Camur's full year 2025 outlook is as follows. Total revenues in the range of 2.7 to 3 billion SEC, representing a growth of 45% to 61%. Profit before tax in the range of 0.9 to 1.2 billion SEC, representing an increase of 63% to 117%. All in all, Camurus closes 2024 with a strong financial position, solid operational performance, interesting growth opportunities, and remains on track to deliver 4.5 billion SEC total revenue at circa 50% operating margin by 2027. Having said that, I would like to pass the word to Richard. Thank you everyone for your attention.

Thank you, John. So I will start with the business in Europe, Australia and the Middle East region. In the fourth quarter, the year finished strongly with Buberdale sales of 469 million sec, which was 11% versus the previous quarter and 28% over the previous year. For the full year sales of Buberdale, we're 1.65 billion sec, a growth of 27% versus previous year. And at the end of the year, we estimate 60,000 patients were currently being treated with Buberdale. In the EU, this was led by the large European markets with UK, France, Germany, and Spain. The strong performance was a result of continued execution of key programs that drive penetration and improve access to Buvidal, resulting in continued market share gain and new patient recruitment across all geographies. In Australia, Buvidal is now established as a first-line treatment. The market share of long-acting buprenorphine in Australia is now estimated at 32% of all patients, and Buvidal has clear leadership in this segment. This is supported by the efforts to improve capacity and access for patients. For example, with a growing number of pharmacies that now have been trained or are now administering Buvidal, which creates space for new patients at clinics. Our market expansion continued and in the quarter we had three new reimbursement approvals that were received in Switzerland, Portugal and Luxembourg and will launch Buvidal in early 2025 in those countries. Additionally, four other regulatory applications are under review. Now, moving across to the US, firstly, a reminder of the US market, where there are an estimated 6 to 7 million people with opioid use disorder, of which an estimated 2.3 million seek treatment in a year, and 1.8 million of those are on buprenorphine. In the fourth quarter, Brookside has strong growth. Net sales grew 43% versus previous quarter, resulting in royalties of 83 million sec and 212 million sec for the full year. The launch continues to outperform previous product launches in this segment. Patient capture was primarily from the large sublingual buprenorphine segment, while the remainder are transfers from other long-acting products and direct initiations into treatment by Brixardi. So 15 months from the initial launch, Brixardi market share has reached approximately 25% of that long-acting segment. And the peak market share potential for Brixardi is estimated to be above $1 billion. Now, to support both Buvedal and Brixardi, the evidence base for effectiveness in different treatment settings and the economic outcomes continues to grow. In the quarter, we have three important publications. First was an exploration of treatment outcome by quantitative urine measures that shows emphasised treatment effect in patients using high level of opioids. Secondly, a naturalistic study showed a clear preference from patients for Brixardi injection over other long-acting injectables. And finally, a paper that explored healthcare professional perceptions that showed high satisfaction for long-acting buprenorphine compared to both methadone and daily sublingual buprenorphine. And this growing evidence base continues being shared for our wide-ranging medical education programmes and at leading Congresses. And on that note, I'll hand back to Fredrik for an R&D update.

Okay, thank you. I will start with CAMP 2029 and the developments across the three target indications, acromegaly, gastroenteropancreatic neuroendocrine tumours and polycystic liver disease, PLD. In Acromegaly, the two AcroEnova phase 3 trials have been successfully completed with positive results. The last few patients in the extension study of AcroEnova 2 will be completing treatment in May 2025, followed by data readout and results. In gastroenteropancreatic neuroendocrine tumors, treatment of patients in the randomized active control Soremto trial continued to progress. with generally positive experiences communicated from participant investigators and clinical staff. Based on an indication of slower than expected rate of tumor progression in the study, especially in this study population of which a majority had advanced disease of grade 2 or 3 when included in the trial, The estimated time for reaching the target of 194 events for reading out the primary results was updated to late 2025 or early 2026. In polycystic liver disease, the last patients entered into the final stages of the randomized placebo-controlled Positano trial, and they are now in the process of completing the core phase of the study with primary results expected in the second quarter of this year. On the regulatory side, we looked forward to an FDA approval on the PDUFA date of 21 October, after late-stage labeling discussions with the Agency. Instead, we received a complete response letter from the FDA, which solely related to a GMP inspection at the third-party manufacturing facility. No concerns were related to CHEM 2029 safety, efficacy or chemistry manufacturing and controls. The manufacturer has responded to the observations and is currently waiting for the FDA to share the establishment inspection report following a recent OAI classification. This will be used to decide the timing of the NDA resubmission, which tentatively is planned for the first half of this year. In the EU, our market authorization application advanced according to plan, and we expect a CHMP opinion around the mid-year 2025, followed by a decision by the European Commission. On the medical side, efforts have been focused on medical affairs and disseminating results and data from our Acrinova phase 3 studies. The main result of the ACRONOVA-1 trial were published in Journal of Clinical Endocrinology and Metabolism in October, and multiple meeting abstracts and new manuscripts have recently been completed and being submitted. Our medical and MSL teams have been very active informing about CAMP 2029, as well as cameras more generally, to the broader acromegaly community and planning for several important events in 2025. Cameras will be present at key scientific conferences and meetings in 2025 with presentations and symposia, as shown in this slide here. We are experiencing a large interest in learning more about the product and doing everything we can to make it available to patients as soon as possible. On the commercial side, we continue preparing for the launches in the US as well as in select countries in the EU. The opportunity for CAM 2029 is considerable, with potential peak sales across indications and geographies estimated to above US$2 billion annually. In the early development pipeline, we advanced a number of different programs for long-acting incretins, for instance, including a monthly semaglutide formulation. A clinical trial application was approved in the fourth quarter, and the first patients were enrolled before the end of the year. The study is now up and running, evaluating pharmacokinetics, pharmacodynamics, including weight loss and safety of CAMP2056 versus current commercially available weekly semaglutide in participants with overweight or obesity who are otherwise healthy. In the first part of this study, we are comparing two dosing schedules of CAMP2056, against the dose titration to label schedule which is existing for weekly semaglutide following this different escalation regimes will be explored and aside from the approved indication of type 2 diabetes and weight management I'm sure you have learned that GLP-1 agonists like semaglutide may also have potential in inflammation, neuropsychiatry and of keen interest to cameras for the potential treatment of substance use disorder. Before wrapping up, I can also mention that we have finalized the setting up of our new headquarters in Lund, where we are currently sitting. And we have built here a state-of-the-art lab tailored to our different needs from early to late stage development. And this will of course be used here to support our planned business expansion during the coming years. Based on a very successful 2024, we have laid the foundation for 2025, where we expect to see increased bubidol penetration, acceleration of Bixari sales in the US, obtain approvals for CAM 2029 in acromegaly, deliver clinical results for CAM 2029 in polycystic liver disease, and also for the new program CAM 2056. In addition, we plan to diversify our business through business development activities and overall contributing to a positive financial outlook for 2025, which we have shared earlier today and in this presentation by John. Regarding the 2027 vision, we continue progressing in all four areas and remain on track to meet our target of revenue, U.S. commercialization, pipeline progress and operating margin. So with this as a final note, I hand over the call to our operator for Q&A.

Thanks. And our first question comes from the line of Victor Sundberg from Nordea. Please go ahead.

Yes, hi, and thanks for taking my questions. So I had one on your guidance. You gave quite much color on the cost side, but I just wanted to get some more detail on total revenue guide. So looking at Buvidal and the specific markets that you see accelerating the growth here in 2025, you previously talked about Germany and the challenges with reimbursement for long acting. So I just wonder if there's any update here or in other key geographies. Also on polycystic liver disease for CAMP 2029, it looks quite a risk study given the data that we have seen on Sandostat in LARP. But I just wondered what the next steps would be if the study would read out well here in Q1. Could that be registrational or do you need a phase three and how would that look like in terms of size, control arm, et cetera? And just finally, I just wondered also, around your M&A strategy you're being quite forward that that you look for M&A opportunities so any comment if that is still the case and what kind of assets you think could fit within within your company at this stage thank you thank you Victor I mean on the first question I think we continue to see a lot of the drive in the large European countries as Richard said earlier so that's

And that includes, of course, Germany, the UK, but also more increasingly, we see progress in Spain and also France and other countries. So that's, I think, our focus area from a geographical perspective. Richard, any more? No, I think that covers it. When it comes to the polycystic liver disease, of course, that is a very interesting study for us. And this is an indication where there's currently no treatment. So I think you should regard this as, as we have said, a phase two, three study in the US. We do not believe we will. It will suffice with one study. There's this potential in Europe. But our idea is to based on the data from the phase two trial from Positano, we should formulate the phase three trial, which we are currently planning. And we cannot say anything about the details here. We have been working on it for quite some time now and planning the design and also the timelines for the study. And I think we have a really good starting point here, but we need the data before we can finalize this and come up with the powering of the trial and so forth. But so far we have done a lot of work and I think overall looks interesting. So any follow-up questions on that, Victor, before we move on? M&A strategy. Oh, yes, sorry. Yeah, I mean, the M&A strategy remains as previously communicated. We are chiefly targeting commercial assets or pre-commercial assets. and which are synergistic to our current pipeline or commercial organizations in the different territories where we operate. Victor, any?

Thank you. I jump back into the queue.

Thank you.

Thank you.

As a reminder, if you wish to ask a question, please press pound key five on your telephone keypad. The next question is from Christopher Ude from SCB. Please go ahead. Your line is open.

Hi there, Christopher Ude from SCB. Thanks for taking my questions. I guess the first one is on the regulatory situation. If there's any more clarity you could possibly give, so insight into the reasons for the OAI classification issue. And, you know, is the establishment inspection report all that you need to be able to refile or, you know, what else might be necessary? And what if they say there are still deficiencies? What happens then?

Yeah, that's a very good question. I mean, overall, just to go back, we were expecting to get the classification, of course, as I said, much earlier. So in mid-December and so forth, it's been quite a, yeah, it's an interesting dynamic right now at the agency, if I put it that way. However, I think we have a clear... We know, of course, what the 483s are, or how a manufacturer does, and they were quite satisfied with the state of those being addressed. We are not completely clear on the review history, and that's why we need the EIR, because we need to get clarity on whether or not there are any of the questions that are outstanding. We suppose so. And if so, what the actions we believe are necessary. I think that having studied the 483s, there is nothing that seems to be, from a time perspective, very extensive in... So I think that we are in good shape there, but we certainly need the EIR to be able to better clarify whether or not we have resolved everything or if there is anything left to address by the manufacturer. On the positive note, we don't have anything, of course, with regards to the product. We had no objections and really no comments. We were ready with labeling, so we should be able to move very quickly in terms of refiling.

Okay. And then if I could ask another question around the guidance. I guess in light of this, is it fair to assume that You're assuming an immaterial contribution from Oakleys in 2025. And then how about Brixati? Because last year you had sort of indicated indirectly that the guide from your partner was extremely conservative. If we try to back that up for this year, what are you expecting for Buvidal growth in 2025?

No, I think that, I mean, starting with the first question, you can regard Oakleys to be quite immaterial in terms of its contribution. When it comes to, I'm not really sure about the comment you made there regarding the partner, but I think that, you know, overall, they probably have quite realistic views. I cannot comment their views, and therefore I don't want to to split the two components. So I think that you can regard a majority or a very large part of our guidance to be constituted in terms of revenue of the two, Buvidal and Bixari, but we are not providing them separately at this point.

Fair enough. In terms of, I mean, you had 4,000 patients added this last quarter. Is that the new floor?

We don't have a floor. I mean, we have a target and we are tracking towards the target, which is the 100,000 patients in 2027. We don't have a floor. I think it will vary, you know, by quarter. So we are not foreseeing that we will have a, you know, a constant or have a floor. It will be varying by quarter as we have seen previously. And I think that that's, yeah. But our target remains.

Yeah. If I could just ask a couple more questions around the specific markets, and I apologize, I had trouble hearing the answer on the remuneration in Germany. But let's say starting with that, you know, and so the reform, what factors will determine the timing of that and who or which body decides? And do you have any insight into, you know, yeah, the reasons around that timing?

We know the process, but we have, because we are a commercial company, we have to have a completely hands-off approach here. So we are just following this from the sidelines. We understand that the reason among the different parties that are involved, which is the kind of insurance providers, it is, of course, the medical community as well as the political dimension. What we have understood is that there is a consensus that they need to change the current remuneration basis. We think that would be very good in terms of providing German patients with a much better treatment option and better treatment options. We understand from the latest updates that there is still expectations that this will be finalized in 2025. However, all of these processes are externally driven. So, but I think there is positive view on that and positive development.

Got it. And then I guess, so, If we talk about England, France, Germany, and Spain, which is performing relatively best versus your expectations at the start of 2024 and which the worst? And what gating events in those markets might be required, remuneration aside, to occur in order to deliver on your guidance?

Christopher, I don't think, I mean, I think in terms of performance, I think we have seen very strong performances across markets. So we're pleased with all of these markets that I mentioned. And actually, I mean, we're seeing consistent growth. There might be one or two markets that are having a slower pace this quarter, but overall very good performances overall. So we are pleased with that. And we are also pleased with the fact that we are now able to go in and launch the products in three more countries. And we have processes ongoing in other countries as well. So we look forward to the market expansion possibility that has come up now, both in Portugal and Switzerland. I mean, Luxembourg is a very small country, but still they have a thousand patients there approximately. So that's a very important part, and that market expansion process will continue here going forward. But I can't comment on specific countries.

Yeah, that's all from me. Thank you.

Thank you so much.

The next question from Oskar Haffenlam from Brian Garnier. Please go ahead.

Hi, Tim. Oskar here from BG. Thank you for taking my question. I was wondering if you could provide some granularity on what percent market share you have in major European markets, and if you believe that the uptick in patients added on treatments this quarter will be maintained in the coming year, taking into account the new markets that are to be included. And then my second question would be on the obesity trial, and more precisely, after how many weeks on treatment will you measure the weight loss? And then as a follow-up on that, what would be your estimated threshold for efficacy that would convince you to push the program forward? Thank you.

Yeah, thank you. I mean, when it comes to the European markets, I think, you know, they vary from very high percentages to lower. But maybe, Richard, you can give a comment on the broad.

Yes, I mean, we've shared Australia, obviously, before, and that one's there. And as Frederick said, there's a range. Sometimes it depends, of course, if those markets are high buprenorphine markets or high methadone. But we're making advance of the methadone. So, yeah, I mean, there's a range from up to 30% in some markets and, you know, in high single digits and others.

I think, you know, generally speaking, we can say that in the larger countries, we are around in the low double digit range or high single digit range, whereas in the Nordic markets, for instance, we are up to 35%, even up to 60, 70% in Finland, as we have said before.

Oskar, sorry, it's John. Just to check one aspect. The answer relates to general market shares. Your question was specific to prisons or to general market shares? To general market shares, yeah. Okay, thank you. And then the second one was GFP1, Fredrik.

Yeah. So in terms of the GLP-1 study, we are conducting that based on, you know, the toxicology work that we had done before. So it's currently it's for the CAM 2029, CAM 2056 groups. It's a 12 week period that we are studying. And of course, that includes any dose titration that you might be expecting. In terms of the weight loss thresholds, this is a study looking at pharmacokinetics, tolerability and weight loss. So it's of course not one isolated topic we are looking at. We are looking at the complete holistic outcomes of the study. So I wouldn't comment on the exact threshold because it's still an early study. But certainly we're expecting to see data that will point us in the direction and that we will be able to use for our forthcoming larger trials. So I'm not concerned about that at all. I think we will be able to read out the results and we have a study population of overweight and obese patients. So we will get a good picture of the efficacy also on that note.

Okay, super helpful. Thank you. And maybe just one additional question. For BrickSally in the U.S., since we're on the topic of the prison system, I mean, considering the large portion of patients that are in the prison system, they would be eligible for treatment. I was wondering if at this stage you're already able to give a percentage of patients currently on BrickSally that are coming from this system and how you view this segment moving forward this 2025 and onwards.

I can say that the opportunity is, of course, very significant. We're talking about a large number of patients. It varies by the states, because in some states there is an established treatment system in place, whereas other states do not have it. And that's very much geographically dependent. But overall, the opportunity is very large. And obviously, Brixadi has only been in the market for just over a year. This opportunity is, I said, largely untouched in terms of penetration by Bricsari, as you might imagine.

Yeah, it makes sense. That's all from me for now. Thank you for taking my questions.

The next question is from Mattias Häggblom from Handelsbanken. Please go ahead.

Thank you so much. Two questions, please. So regarding the 2027 targets of 4.5 billion krona in revenues. So historically, 3 billion was expected to be derived from Bovedal-Brixade and 1.5 billion from CAM 2029. With the CRL for Acromegaly, but perhaps more importantly, in light of the market size for GapNet, the longer accrual time of events in Sorrento with a submission, as I understand it, targeted for second half 26. I'm curious to hear if you still expect the 1.5 billion krona contribution from count 2029 by 2027, or is it fair to say that you perhaps expect a larger contribution from Buvidal and Bixada today compared to those initial projections back in 2022 at R&D day? And then I have a follow-up.

Yeah, so I'm not completely sure of your starting point here, because at the R&D date we talked about, I think you're referring mainly to the contribution from Buvidal there in your initial number. But so and then the rest was a mixture. So, no, we we don't see. Obviously, I mean, the acromegaly indication was and remains a small but important indication for us in terms of the camp 2029 franchise. But and we still have a component coming in from CAM 2029 into our 2027 estimates. I don't think we have commented on the size of that, John, have we? No. But we remain, as we say, we remain on track to reach the target and And that's a mix of the different products I referred to. But, of course, the largest contribution comes from Brixadi and Bovidal. No discussion about that.

Okay, there's a slide saying Bovidal bonds penetration 3 billion and late stage product candidates 1.5. So maybe the 1.5 included Brixadi.

Yes, exactly.

That's completely correct. Yeah, that's correct. Because I recall another peak sales potential of bubidol in euros, but maybe historically provided. Correct me if I'm wrong. I thought it was 170 million euros, something like that.

I don't know where that number comes from, but anyway.

Okay. All right. The target is reconfirmed, no matter what. Okay. And then secondly, looking at the FDA Orange Book, there are eight patents listed protecting Brigsald in the longest to July 2032. So once CAM 2029 is approved, are there patents beyond July 2032 that we should expect to be listed in the Orange Book for that product, or are timelines broadly the same? I know you have received often drug designation for, PLD from the FDA, but I'm not aware of such protection for GapNet, for instance, in the U.S. market. So any clarification for long-term IP would be helpful?

Absolutely. So, I mean, in terms of CAM-2029, we have IP covering at least up to 2037. So it's, I mean, there is different IP to that that covers Vivirol, of course. and potentially for longer time periods over time. So we do have a number of filings that extend beyond the Bovedal timeframe.

Thank you so much. Thank you, Mattias. Thank you. The next question is from Victor Sundberg from Nordea. Please go ahead, Victor.

Victor, please go ahead. Sorry, it was a mute. Yes, I just had a follow up on the Sorrento trial also. It seems like you have twice monthly dosing in that trial. Is that a way to boost your arm versus the control arm that's given once monthly? Do you expect higher bioavailability of the active compound? that so to speak there is the readout of this trial since it seems that retrospectively it is the higher bioavailability and its correlation to progression-free survival that seem to drive your optimism around this trial. Any comment here would be helpful.

Yeah, it's correct. I mean, the higher bioavailability is definitely consistent also for in the net indication. So in fact, the AUC, the area on the curve, so the total exposure of the treatment period is roughly about seven

...seven times higher for... ...2029 at the... ...dosages given in the net trial... ...compared to the reference product... And then I have to, of course, refer to the... retired reference product because in the