Camurus AB

reaching 40 million SEC compared to the same period last year. And then R&D investments were 109 million SEC, a reduction of 33% compared to the same period last year. This is mainly due to the completion of ARCA-RENOVA trials and the absence of clinical trial milestone payments in the Sorrento and Positano programs during the quarter. Looking at the cash flow for the quarter, Chemuris increased its cash position by 167 million SEC, mainly driven by the operational activities adding 221 million SEC and proceeds from the employee stock option program adding 43 million SEC. Working capital investments decreased cash by 97 million SEC, resulting in a net cash position of 3.5 billion SEC, which is an increase of 28% compared to last year. Moving to the update of the 2025 financial guidance. Despite positive development in Brickside and Buberdale, revenue do not live up to our previous expectations and guidance for the full year. This is primarily due to Brickside U.S. revenue is below the previous projections and there is uncertainty about the timing of a sales milestone. In addition, we have seen continued delays in allocation of committed governmental funding for the treatment in the U.K., But importantly, our profitability has continued to develop positively with good financial discipline across the organization, and our planned U.S. expansion has been aligned with the updated approval timeline for both places. As a consequence, our restated full-year 2025 outlook is as follows. Our revenue guidance is lower to 2.3 to 2.6 billion Swedish kroners. and a profit before taxes unchanged in the range of 0.9 to 1.2 billion Swedish kroners. So nevertheless, Camurras ended the third quarter with a healthy financial position, promising outlook for continued growth, profitability, and pipeline progress. With that, I would like to hand over to Richard.

Thank you, Anders. I'll start with the Cameras markets. So net sales for Buvedal in the quarter were 455 million sec, up 8% year on year or 15% at constant exchange rate. Versus Q2, sales were down 3%, primarily due to the economic lower than expected orders in the UK, which also led us to reduce infantry levels. In contrast, underlying in-market sales grew 3% versus Q2 and are 21% year-to-date, driven by maintained growth in Australia, Norway, France and Spain as we continue to execute on our plans, while we saw a flattening of growth in the UK and Germany due to two main factors – In the UK, there are ongoing delays in allocated funding reaching community clinics. However, growth began to accelerate in the criminal justice setting as allocated NHSE funding for long-acting injectable buprenorphine treatment in prisons has become available. In Germany, resistance to uptake remains due to the ongoing remuneration of physicians based on daily visits. Year-to-date in-market growth is positive, around 20% across markets, with the exception of Finland, where growth was single-digit due to the high penetration we have there. There continues to be high demand from patients and physicians for long-acting injectable buprenorphine, and we continue to support this through active programmes that build awareness of the benefits the product brings to patients and wider society. This, in turn, is increasing demand for wider accessibility and is expected to deliver renewed growth in 2026. So on the next slide, I share more detail of our ongoing strategy for improving patient access. We are continuing to grow the real-world evidence base and develop economic models that demonstrate the improved outcomes and the value long-acting buprenorphine brings over daily treatments. The economic models, of which there are some publications on the left-hand side of the slide, clearly demonstrate the positive value of treatment with AIB, typically showing a more than three-time return for governments. These data and models are a critical part of our initiatives to improve access through a government affairs programme that is engaging a wide group of policy stakeholders who will benefit from improved access to these innovative treatment options. As a result of these programmes, we are seeing growing demand in criminal justice settings and the need for the continuity of care on release, alongside support to address funding in community settings. This has already resulted in some success, including allocation and distribution of funding from the criminal justice setting in the UK that I mentioned earlier, and regional funding expansion in France. We also understand good progress is being made on alternative remuneration models in Germany that would address this key hurdle for Buvedal. The success of this activity is critical to expand the use of Buvedal in these markets in 2026. Now, moving across to the US, Brixardi had a strong quarter, as you've already heard, with royalties growing 25% versus previous quarter and 91% year-on-year. Brixardi continues to outgrow the market and has reached an approximate 30% share of the long-acting Bruper Northing segment, which in itself is growing 25% year-on-year and for the first time reached annualized sales of US$1 billion. In the U.S., Brixardi represents a significant opportunity for future growth through penetration of the sublingual buprenorphine market with an estimated 1.8 million patients in treatment and with further potential in the criminal justice setting. Brixardi has a clear and differentiated profile, and Braeburn are successfully navigating the challenges in the OUD treatment market. So overall, we remain optimistic about the prospects for BRICS-RD in the U.S. and the potential for significant growth in the coming years. And on this, I'll hand back to Fredrik.

Thank you, Richard. So let's move over to a quick pipeline update. So starting with the progress of the Octreotide Depot programs for acromegaly, gastroenteropancreatic neuroendocrine tumors, GEPT-NET, and polycystic liver disease, PLD. So as you know and have heard before, we have a large clinical program for CAMP 2029, which represents a major investment and a future potential for cameras. In Acromegaly, we have successfully completed the AcroInnova program, delivering positive results from two pivotal phase three trials, as well as long-term extension study. In GEPNet, we advanced the Sorento trial towards the improved important readout of the primary efficacy results in 2026. Finally, we recently completed the Positano study in PLD, also that with positive results for the primary endpoint. I will start here with an update of the Sorento study in GEPNet. This was recently discussed at a well-attended scientific symposium at the North American Neuroendocrine Tumor Society meeting in Austin, Texas, where it rendered significant attention among the participating physicians and other healthcare providers. The topic of the symposium was dose optimization of somatostatin receptor ligands, which is the efficacy-driving hypothesis behind the Sorento trial. So chair of the symposium was Dr. Jennifer Chan, president of NANETS, and presenter was Simran Singh, University of Toronto, who is the president-elect of NANETS, actually now the president of NANETS. Both are Sorrento Study investigators and steering committee members. The conclusion of this discussion was that there is very high hopes and good prospects for Sorrento and CAM2029, of course, providing positive outcomes. Patient recruitment in Sorrento was started already in Q4 2021, which means that the first enrolled patients have now been in treatment for about four years, in many cases without disease progression. The study was fully recruited at the end of 2023, as all patients have been assessed for about two years or longer. So far, the experiences from the trial are generally very positive in terms of patient feedback and the projections for completing the randomized efficacy part of the trial has been extended based on the lower than predicted rates of progression-free survival events during the past few months. We recently completed a new analysis of the accrual rates in the study, and based on the trends, we have updated the projections for reaching the 194 events for the study to mid or second half of 2026. From a CAM 2029 and study outcomes perspective, the adjustments should be positive while also extending the time to primary results. To put this in perspective, I would like to highlight the study design and patient population that is part of the STORENTO trial. So compared to previous studies of tumor progression, Soremto is a randomized active control study with a primary objective to assess the superiority in progression-free survival for treatment with CAM-2029 versus standard of care with first-generation somatostatin receptor ligands. It is indeed the largest ever study of an SRL performed in patients with neuroendocrine tumor surgery. And a majority, and this is an important point, of the patients in Sorrento has advanced grade 2 or grade 3 neuroendocrine tumors at baseline compared to no or a minor portion of patients in the earlier tumor control trials, PROMED and CLARINET. The progression-free survival for the blinded population in Sorrento should be viewed in the context of the study population, which makes us optimistic about the study prospects. Moving over to PLD, during the quarter, we continued analyzing data from the Positano trial in preparation for an end-of-phase-2 meeting with the FDA planned for early next year. Furthermore, CAM-2029 was granted orphan drug designation for autosomal dominant polycystic kidney disease, ADPKD, both in the US and EU during the period. Pointing to the high unmet medical need in this indication, importantly, this can also expand the future orphan drug exclusivity to PLD arising from ADPKD. So that is significant progress in itself. Finishing off with the Acromegaly indication, Oxyisa has now been granted market authorization for the treatment of Acromegaly in both EU and the UK. For the US, the NDA has been updated during the quarter and is ready for resubmission as soon as we have received green light from an inspection at the contract manufacturer. Please remind yourself that there was nothing in the CRL from the FDA that was related to the product itself or its clinical or safety data. Based on our plans for resubmission, we expect a new PDUFA date and a potential US launch of Oclase in the first half of 2026, which will, of course, be an important event for us. In parallel, we are preparing for launches of Oxys in Europe, the first monthly subcutaneous octreotide medication in the market, enabling convenient self-administration for patients and enhanced octreotide plasma exposure. The European launch has now been initiated in the Wave 1 countries with an estimated 3,000 to 5,000 acromegaly patients currently treated with first-generation long-acting somatostatin receptor ligands. The response to the Oxy-ISA profile from physicians and patients has so far been very encouraging, with a positive view both on this and clinical data. And market research that we have performed in the area show a high willingness to switch to Oxy-ISA from current somatostatin receptor ligands. In addition to this, we have also had positive initial feedback from payers, So as you may have seen from the announcement earlier this week, on Monday, Oxisa has now been launched in Germany as the first country in Europe and globally, and our medical affairs and sales team are now out in the field. Germany represents a substantial opportunity with about 2,000 patients currently in treatment with first-generation somatostatin receptor ligands. and with an annual sales potential of over 50 million euros. A recently performed physician survey suggests that about 30 to 60% of these patients are initially considered suitable for switching to Oxyisa. Obviously, Gepnet represents a much larger opportunity. However, Acromegaly is, of course, a great starting point here. Alongside the advances of the CAMP 2029 program, we have also completed treatment of the last patient in the Phase 1b study of our monthly semaglutide formulation, CAMP 2056, based on our fluid crystal technology. We now expect to provide top-line results this month with focus on tolerability and, of course, importantly, efficacy indicators such as body weight and HbA1c. In addition, we progressed our strategic partnership with Eli Lilly for the development and commercialization of long-acting incretins in the cardiometabolic area. including GLP-1-GIP dual agonists and GLP-1-GIP glucagon triple agonists. And we are naturally very excited about progressing this collaboration. So with this, I think it's time to finish off with some key takeaways of the quarter. In summary, we had a good quarter. As you have heard, not without challenges. However, we did significant advances and progressed and expanded our business, delivering strong profitability and cash flow, stable moving on sales in Europe and Australia. I think our team are doing an excellent job also with regards to the future development in the market. Notably, Brickside had another good quarter in the US, outgrowing the rest of the market. In addition, for Oxuisa and Acromegaly, we received the UK approval. and prepared the launch in Germany. And also, as I mentioned recently here, we advanced our promising long-acting Incrutin pipeline. With this final note, I think it's time now to move over to Q&A. So please, Einar, take over the call.