Welcome to Camurus Q1 Report 2025. During the question-and-answer session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now I'll hand the conference over to CEO Fredrik Tiberg. Please go ahead. Thank you so much, Einar, and good day, everyone. Thank you for joining our first quarter earnings call. As previously, please note our forward-looking statements. The agenda for today's call is as follows: we start with business highlights, followed by reviews of financial and commercial performance, then finish off with a short R&D update before moving over to Q&A. As previously, with me today are Jon Garay, our Chief Financial Officer, and Richard Jameson, Chief Commercial Officer. Overall, Camurus had a productive and highly profitable first quarter 2025. This was driven by continuous commercial execution in Europe and Australia, strengthening our leadership position in opioid dependence treatment. Overall, sales increased to SEK 485 million, increasing 6% versus the previous year at constant exchange rate. Brixadi royalties from the U.S. increased 185% versus previous year; however, they were flat versus the previous quarter at constant exchange rate. Notably, the overall buprenorphine OUD market in the U.S. was down 13% during the same period. In the R&D pipeline, dosing was initiated in a phase I study of our once-monthly semaglutide. The phase III SORENTO/ POSITANO studies of CAM2029 in neuroendocrine tumors and polycystic liver disease progressed according to plan. In addition, after the period, we received positive CHMP recommendation for approval of CAM2029 in acromegaly in the EU under the trade name Oczyesa. Financially, we had a strong first quarter with operating results growing 204% year on year to SEK 239 million. In parallel, we continued strengthening our sustainability profile, inaugurated our new headquarters in Lund and R&D laboratories, and after the period, we announced the appointment of Anders Vadsholt as our next CFO, joining Camurus on the 1st of July, thereby ensuring a smooth transfer over from Jon. With that said, let's move over to a financial update. Thanks a lot, Fredrik, and good afternoon, everyone. Camurus delivered a strong financial performance in Q1, and we would like to share now its main highlights. Camurus achieved SEK 558 million total revenue in the quarter, delivering a growth of 43% versus the same period last year, with product sales of SEK 485 million, growing 33% versus the prior year and 3% versus the prior quarter. Swedish krona appreciation has impacted reported figures negatively by three percentage points versus the prior quarter. Brixadi sales in the U.S. represented a SEK 74 million royalty income in the quarter, growing 185% versus the prior year and 1% versus the prior quarter at constant rate. Swedish krona volatility has impacted negatively royalty reported figures by 12 percentage points versus the prior quarter, hence the minus 11% growth you can see in our reported numbers. Company profit before taxes was SEK 254 million, representing 45% over sales and growing 162% versus the prior year. Earnings per share after dilution was SEK 3.29, equivalent to a profit after tax of SEK 197 million in the quarter. Finally, our cash position was SEK 2.9 billion at the end of the quarter. Moving to the next slide, we can see the main components of our profit before taxes. Company gross margin reached 93% in the quarter, representing an improvement of 88 basis points versus the same period prior year. The improvement was driven by three major factors. Firstly, geographical mix represented 29 basis points. Secondly, 40 basis points are driven by Brixadi royalty. Thirdly, FX represented a positive impact of 19 basis points. Total OpEx reached SEK 289 million, remaining flat versus the same period prior year, driven by the following factors: marketing and distribution investment to support market penetration in own territories, expansion of Buvidal into new markets, and U.S. operations grew 25% to SEK 116 million. Administrative expenses aligned with corporate evolution to substantiate company development grew 158% versus the same period last year to SEK 42 million. R&D investment reached SEK 131 million, 27% below the same period prior year, driven by lower milestones in our ongoing clinical trials and acromegaly study ramp-down. Company profit before taxes reached SEK 254 million, growing 162% versus the prior year and representing 45% over sales. Company cash position at quarter end was SEK 2.9 billion. Camurus improved its cash position by SEK 25 million in the quarter, driven by the following four factors. Firstly, company operations generated SEK 246 million. Secondly, working capital increased by SEK 168 million, driven by receivables growth, payables, and liabilities reduction following R&D milestones and company bonus payout. Thirdly, company invested SEK 34 million in new headquarters and technological activities. Finally, company balance sheet translation represented a negative impact of SEK 12 million. At the end of the quarter, Camurus has no debt. All in all, Camurus closed its first quarter 2025 with a strong financial performance, interesting growth opportunities, and is on track to deliver the 2027 vision. Having said that, I would like to pass the word to Richard. Thank you, everyone, for your attention. Thank you, Jon. I'll start with the Camurus markets and then move across to the U.S.. Starting with Camurus markets, which include Europe, Australia, and the rest of the world, we continue to deliver strong performance across geographies, with net sales growing 33% versus previous year and 6% versus previous quarter at constant exchange rate. At the end of the quarter, we estimate close to 63,000 patients are in treatment with Buvidal. Growth was seen across our markets, led by U.K., Australia, Germany, and Nordics, as our teams continue to successfully improve access for patients through addressing funding by demonstrating the value Buvidal brings to healthcare and society, the growing awareness of innovative treatment options, and supporting informed choice for patients and those outside of treatment. Alongside this, our sales teams continue to execute on their plans to drive penetration at a clinic level. We further expanded into new markets with launches and first patients treated in both Switzerland and Luxembourg, and finalized the reimbursement process in Portugal and have launched at the beginning of Q2. Additionally, we received regulatory approval in Serbia and have initiated the reimbursement process, and three other regulatory applications are under review. Now moving across the U.S., as Jon has already said, the royalty from Brixadi grew 185% year on year and grew 1% in the quarter at constant exchange rate, with an FX headwind of -1 2% in the quarter. The U.S. buprenorphine market was challenging, as down 13% compared to the previous quarter. This is likely due to a combination of transient headwinds, including the unwinding of Medicaid continuous enrollment that was set up during COVID, ongoing budget restrictions in federal prisons limiting access of long-acting buprenorphine, alongside the usual seasonal impact on new authorizations. Our licensee, Braeburn, expects Brixadi to deliver renewed growth in the coming quarters as these headwinds diminish. On that, I'll hand back to Fredrik. Okay, thank you, Richard. Over to a short R&D update then, and beginning with the progress with CAM2029 across our three indications. Starting with acromegaly in the clinical program there, we have previously completed and reported positive results from the ACROINNOVA 1 efficacy study, as well as the core phase of the long-term safety and efficacy study, ACROINNOVA 2. During the first quarter, dosing of the last patients in the extension of ACROINNOVA 2 was completed, and results will be presented at upcoming scientific meetings and in publications. In gastroenteropancreatic neuroendocrine tumors, the SORENTO study has progressed according to plan, and we expect to reach the target number of PFS events early 2026 to start reading out the primary results from the trial. Finally, in PLD, we have completed treatment in the randomized part of the POSITANO study and expect to present top-line results later in this quarter. To remind you, POSITANO is a 53-week randomized three-arm study of two doses of CAM2029 versus placebo. The study has included 71 patients with symptomatic polycystic liver disease. The primary endpoint is height-adjusted liver volume, and the key secondary endpoint is patient-reported symptoms determined and reported by PLD-S questionnaire, which has been developed internally by Camurus based on FDA guidance and our also collaborator. In addition, there are multiple secondary endpoints assessing, for instance, cyst volumes, quality of life, and safety for patients treated with CAM2029. Based on the results of the POSITANO study, we will initiate discussions with the FDA and EMA about the pathway to registration of CAM2029 in polycystic liver disease. If approved, CAM2029 could be the first pharmacological treatment available for people living with polycystic liver disease. Moving over to the regulatory side, the registration processes for CAM2029 in acromegaly continue to progress in the quarter. As a consequence, we were pleased to announce a positive CHMP opinion for EU approval of CAM2029 in acromegaly. The EMA review process has progressed very smoothly, faster than we were hoping for initially, and a final market authorization decision is expected from the European Commission during June. Regarding the U.S. registration process, we are ready to resubmit the NDA as soon as we have received comfort about the CRL resolution at the third-party manufacturer. For this purpose, we have instituted an independent audit of the manufacturer, and this is scheduled to the end of this quarter. As soon as possible after that, we will resubmit the application. Ahead of potential regulatory approvals and launches of CAM2029, our medical team has been busy disseminating results from our clinical trials at key scientific meetings and conferences. We've got excellent response. As an example, about 600 participants attended our satellite symposium at the European Society for Endocrinology meeting in Copenhagen this previous weekend. The coming weekend, our U.S. team will be attending AACE in Orlando, and later in July, we have the big endocrinology ENDO meeting coming up in the U.S.. In parallel, we continue working with pre-launch activities in the U.S. and Europe, including payer interactions. In the early pipeline, we advanced our clinical study of our once-monthly semaglutide formulation in participants with obesity or overweight, as well as R&D activities relating to other long-acting incretin candidates. In the clinical study, all participants in the randomized part A have now been dosed with CAM2056 or weekly semaglutide comparator, and most patients in the dose-escalating part B trial of the study have also been included and received at least one dose of CAM2056. Top-line results from the study are expected in the second half of the year. With that, it's time to wrap up. I want to finish by saying that Camurus had a solid first quarter with record-high profitability from operations, continued Buvidal growth in Europe and the rest of the world. Brixadi U.S. sales held up in a challenging U.S. OUD market, and in addition, we started dosing in a phase I study of CAM2056. After the quarter, we received a positive CHMP opinion for Oczyesa in acromegaly in the EU. With this, I would like to thank you for listening, and Einar, let's move over to Q&A. Thanks. The first question comes from the line of Suzanna Queckbörner from Handelsbanken. Please go ahead. Your line is open. Suzanna. Hello, Suzanna Queckbörner here from Handelsbanken. Hi. I'd like to ask my questions one at a time, please, starting with the Australian market. Your Australian sales have reached SEK 187 million in the quarter. That's over 90% year-on-year growth and a large step up compared to Q4. Given that Australia is actually quite a mature market, I'm curious to understand whether this is a timing of order situation and maybe something that's worth quantifying from your side. Help me understand this better and how that would impact Australian sales going forward. I think I'll leave the question over to Jon. Okay. Thank you very much, Fredrik. Thanks a lot, Suzanna, for your question. To the best of my knowledge, we do not disclose the Australian sales. If I remember okay, in the page 30 of our report, note for what we disclose is Africa, Middle East, and Asia, including Oceania. If you refer to the sentence below the table, it refers to customer. We do not disclose in which country is this customer. What you may rest assured is compared with prior year, and this is public information. Last year, the Australian government implemented the Pharmaceutical Benefits Scheme starting by the second half of 2023 and finalizing in the first half of 2024. We were very transparent that all the pharmaceutical providers in the country, they would have ups and downs last year in their sales to the government. That is what happened last year. Coming back to your question about the market's performance, no, we are very confident on our execution and the execution by our team in Australia. We continue having a successful market share of about 80%. So far, we are delivering according to our plan. Is that right, Richard? That's correct, yeah. Okay. Thank you very much. Maybe just stress that we are expecting to see continued growth over the next quarters in Australia. Right. Okay. Just as a quick follow-up question to that, with this extraordinary customer, is it fair to assume that they may not just supply to one geographic region? We are not disclosing the split of our customers by region. I know, Suzanna, the information published by region for competitive intelligence reasons is the one disclosing in the note for. Suzanna, are you there? Okay. I'll get back in line. Thanks. Yes? Suzanna. If I can ask. Sorry. Victor is coming up here now. Yes. Hi. This is Victor Sternberg from Nordea. Hi, Victor. Yes, you're ready. Ready to take questions from you, Victor. Yeah. Hi. Can you hear me? Yes. Yes. Yes. Hi. Thanks for taking my questions. Yeah. Just a question here on your U.S. market. I know it's your partner responsible for that, but just any color here would be appreciated. On Medicaid unwind, I mean, this has been going on quite some time, also last year, and it seemed to impact your partner, Braeburn's competitor in the U.S. in Q3, Q4, etc., but was never mentioned from your side. Was it also impacting your growth last year as many patients lost Medicaid for a shorter period of time when this unwind process was ongoing? I think I start there. Yeah, I think that is very highly likely. I mean, all the industry was impacted by this provision, the unwinding of the Medicaid continuous enrollment provision. However, the growth rate of Brixadi was so high, and actually, it was not a factor that we had raised to us at that time point from the information we received, so to speak. Obviously, it became more clear in the data coming out here from the first quarter. We believe that this effect is diminishing over the year. It's probably from the data we have looked at now, it probably was maxed out in the first quarter, and we believe it's diminishing going forward. Our licensee has also informed us that they are expected to see renewed growth in the coming quarters. Are you hearing me? We seem to have a short delay. Okay. Thank you. How good visibility do your partner have here? I mean, we have April in the books. Yeah. I mean, we have also established visibility through our third-party providers of data. So Viva is now supplying us with the data on these topics. We have visibility here from both angles. Yeah. Thank you. I think my question was cut off a bit. I also wondered, I've seen that states can continue to unwind Medicaid until June 2025, if I'm informed correctly. As you said, was it maxed out here in Q1, and you don't expect much in Q2 to happen? Just as a second question, FX has, of course, moved quite a lot here versus when you put out your guidance for the full year. Does this mean that you have seen even stronger underlying growth that will offset FX headwinds, or how should we interpret your guidance with regards to foreign exchange movements? Thank you. Thanks a lot for your question, Victor. When we provided our guidance in mid-February, we already simulated different FX scenarios. At the moment, we are working inside those scenarios that our partners, banks, provided to us. Our guidance, as stated in our report, at the moment is maintained. Are you there, Victor? Okay. Thank you. Just a quick final also on polycystic liver disease. Can you give that in LAR has had some good data, but this read-up, could it be enough for any kind of approval, or should we see more? Should we need to see more in order for approval here? Maybe just a quick word on the commercial outlook for this indication that does not currently have any approved products. It could be helpful as well. Thank you. Yeah. When it comes to the registration route, we have already said that we do not expect that there will be an approvable trial for the U.S. and for Europe. It is also, I would say, still quite optimistic to believe that one phase two/three trial will be registrational in this indication. However, we have not had that discussion with the European authorities yet. The intent is to start a registrational phase three trial as soon as we can after reading out the data. When it comes to your ask about the market. Okay. Thank you very much. Yes. I also asked about the commercial outlook. Sorry for the bad quality. It's very hard to. Yes. We have provided. Yeah. We have provided our market estimates for the polycystic liver disease indication, and it is, what I say, in between acromegaly and the neuroendocrine tumor indication. So in our previous estimates that we have shared, it's between $300 million and $400 million peak market potential estimated. Okay. Thank you very much. I jump back into Q. The next question is from Richard Ramanius from Redeye. I'm sorry about the delay. When speakers are handing the word over to the analyst, there is a delay, but not the other way. Hi, Richard. Good afternoon. We have four questions, starting with CU. Have you noticed any impact of the label change for your competitor's products that was announced in February? No, we have not seen any impact on the. Of course, it would be an indirect impact, but we haven't seen any so far. Okay. Good. A question about CAM2029 in acromegaly. When would you expect to get the PDF date of submission, and when do you think you could start selling it? I know it's a long registrational product to get it registered on all the European markets. There are two possibilities theoretically. It is the class one resubmission route, which will be two months after submission or resubmission. The other is a six-month process, which would be more aligned with if there is a requirement of inspection, reinspection of the manufacturer, then it is more likely that it will be a six-month process. Two to six months is the answer to your question. Any other question? Yeah. Good. Also, yes, I have two financial questions. You mentioned the incremental capital investments of SEK 0.35 billion to fully deploy U.S. operate is capitalized, and how much of that is registrar's cost? Sorry, Richard, there is a lot of noise on your line. I could not understand your question. Would you mind repeating it? Yes. The question was, you mentioned the incremental investment of approximately SEK 0.35 billion to fully deploy U.S. operations. I wonder how much, if any, of this is capitalized. I mean, how much of it ends up on the balance sheet? None. In our market guidance, the SEK 0.25 billion was not only to deploy U.S. operations, was to support the launch of acromegaly in U.S. operations and globally as well. All of it is OpEx, Richard. Okay. I also wonder about your transaction you plan to do. Do you think that's going to be a transformative large transaction where you might need to use more than just the cash on hand, or do you think it would be more of an operational deal, like a licensing deal? I think both are possibilities at this stage. We are continuing our work on the M&A side, and it could be both transformative and additive. We have not given any specific direction there. Both possibilities. Okay. Very good. Thank you. That were all my questions. The next question is from Sean Homer from Jefferies. Please go ahead. Your line is open. Hi there. Just a few from me as well. We can take them also one at a time. Firstly, could you give us perhaps a rough estimate or just some, I guess, qualitative color of how much Brixadi sales come via the criminal justice system channel? If possible, how much of that is from federal prisons versus from state prisons? Thank you, Sean. Actually, for competitive reasons, we do not provide that information from our partner. We have informed that Medicaid is the single largest payer in our mix, followed by commercial, and then we have Medicare, and finally, then federal. It means that, I mean, likely, it is not one of the largest; it is not a large fraction in the mix, but noticeable. Understood. Thank you so much. What gives, I guess, obviously, this is more for Braeburn, but what gives you and your partner, Braeburn, sort of confidence to return to growth for Brixadi, and obviously, by extension, your royalties over the coming quarters? It seems like some of the headwinds, such as the budget cuts, are potentially unlikely to resolve. Yes. I mean, as you said, the question is perhaps not directed to us specifically, but I would say that the medical need consistently is there, and you still have over 2 million people in need of treatment. If you look at the development over the course of the last quarter, even though it's been very tough, there has been an increase in the market share for long-acting injectables in this climate. I think that gives a good position once things are easing off and these transient issues are being slowly addressed. I think we have only had really one quarter with these numbers for Brixadi. It's been a It's been a short process so far. Got it. Thank you so much. Just one clarification from me. In your 2025 guide, you include a small portion of revenues from Oakley. Is this EU only or both EU and U.S.? If I remember okay, Sean, in our market guidance for 2025, we have not provided clarity if there is any amount for Oakley. Analyst, yes, you are assuming Oakley and so on, but in our guidance, we have not disclosed and provided any, I would say, any direction about how much is Oakley and if it is only U.S. and Europe. At the moment, I would like to stay at that stage. Thank you so much. There are no more questions from the telco. So I hand the word back to you, Fredrik, Jon, and Richard. Thank you. I would just like to thank everybody for listening in, and I look forward to meeting you after this update and hopefully also next quarter. Thank you very much for joining the call, and have a great day.