Welcome to Camurus' Q3 report 2023. During the questions and answer session, participants are able to ask questions by dialing star five on the telephone keypad. Now I will hand the conference over to CEO, Fredrik Tiberg. Please go ahead. Thank you so much, Einar. Good day, everyone. It's been a pleasure. It's a pleasure to have the opportunity to share our third quarter performance and results with you today. It's certainly been a good quarter for Camurus. Before starting the presentation, please note our forward-looking statements. The agenda for the call today is a third quarter highlight overview, followed by financial results, commercial and pipeline updates, and then we will finish off with Q&A. In today's call, I'm joined by Jon Garay, our Chief Financial Officer, and Richard Jameson, our Chief Commercial Officer. As you may already have seen in this morning's report, Camurus delivered a strong third quarter performance, resulting in very positive financial development, with high double-digit revenue growth to SEK 384 million in the quarter and SEK 1.3 billion year-to-date. Our operating result was SEK 104 million in the quarter, and SEK 554 million year-to-date, including also costs for 3 extensive phase 3 programs. Our cash position increased to 1.15 billion SEK, including a $35 million payment received from Braeburn. As a result of the strong financial performance in the quarter, we have recently raised our guidance for 2023. We continued our commercial execution in the opioid dependence area, and saw Buvidal sales grow by 44% year-on-year to SEK 346 million in the quarter. In the US, our licensee, Braeburn, launched Brixadi for treatment of opioid use disorder, which was, of course, an important highlight. This also resulted in the first royalty payments in the quarter. In addition, we had good progress in our R&D programs, with positive top-line Phase 3 results in acromegaly, pre-NDA meetings with the US FDA, and accelerated recruitment in our large SORENTO study. All in all, our teams delivered excellent performance in the quarter, and we are well positioned to deliver on our ambitious plans and strategy going forward. With this, I'll hand over to Jon for a financial update. Thanks a lot, Fredrik, and good afternoon, everyone. We would like to share key highlights of our financial performance this quarter. Camurus achieved SEK 384 million total revenue in the quarter, delivering a growth of 59% versus same period last year, with product sales of SEK 346 million, growing 44% versus prior year and 13% versus prior quarter. Additionally, in product sales, Camurus recognized SEK 25 million revenue related to the expiration of Braeburn's option period for Buvidal in China, Japan, Korea, and Taiwan. And for the first time, Brixadi sales in the US represented a SEK 1 million royalty income following its commercial launch on September the fifth. Company achieved an earnings per share after dilution of 1.5 Swedish kronor, equivalent to a profit after tax of SEK 86 million in the quarter. Finally, company cash position at quarter end was SEK 1.15 billion, representing a 122% improvement versus same period prior year. If we now move to next slide, we can see the main components of our operating result. Company gross margin reached 91.7% in the quarter, with product sales gross margin at 90.8%, representing an improvement of 80 basis points versus same period prior year, which is driven by supply chain efficiencies as Buvidal volumes scaled up. On a year-to-date basis, product gross margin was 90.4%, representing 135 basis points improvement versus the first 9 months of prior year. Total OpEx reached SEK 253 million, representing a 37% increase versus same period prior year, driven by following three factors: Marketing and distribution investment to support market penetration in own territories and expansion of Buvidal into new markets grew 41%. Administrative expenses, aligned with corporate evolution to substantiate company development, were flat versus same period last year. R&D investment reached SEK 148 million, growing 39% versus same period prior year, driven, on one hand, by progress in our ongoing three phase 3 trials, mainly recruitment progress in NET and PLD, and on the other hand, read out of AcroInnova-2 top-line results. Company operating result, as a consequence, became positive by SEK 104 million in the quarter. If we now move to next slide, company cash position at quarter end was SEK 1.15 billion. Camurus generated SEK 500 million cash in the quarter, driven by following three factors. Firstly, company operations generated SEK 121 million. Secondly, working capital improvement drove SEK 365 million, driven by collection of Brixadi milestone following FDA approval in Q2. And thirdly, exercise of warrants program delivered SEK 17 million cash. At end of quarter, Camurus has no debt. All in all, Camurus closed third quarter with a strong financial position, solid operational performance, and interesting growth opportunities. As a consequence of such a strong performance year to date and Q4 expectations, Camurus guidance for total revenue was increased to the range of SEK 1,640 to SEK 1,720 million, from prior range of SEK 1,530 to SEK 1,650 million. With profit before taxes estimated in the updated range of SEK 525 to SEK 600 million, from prior range of SEK 425 to SEK 525 million. Company is on track to deliver the long-range plan vision shared at Capital Markets Day celebrated in September last year. Having said that, I would like to pass the word to Richard. Thank you everyone for your attention. Thank you, Jon. I will give a brief update on the strong progress in Camurus markets, and an update for the US following the first three weeks of the launch of Brixadi. If we start with the Camurus markets, Q3 was another strong quarter for our teams in Europe, Australia, and the MENA region. Our net sales reached SEK 346 million, which is 44% up versus the same period last year, and 13% ahead of Q2. We had underlying strong in-market performance with additional positive contributions from currency exchange rates and also some stock in from distributor markets. We now have an estimated 45,000 patients being treated with Buvidal in the quarter. We saw good growth across our markets, notably UK, Nordics, Germany, Austria, and Spain. Highlights include further acceleration in the UK, as recent funding from government reached treatment clinics. 6% of the patients across the UK are now in treatment with Buvidal. Additionally, the UK Health Select Committee, who review the progress on the government's drug strategy, reinforced the value that long-acting buprenorphine can bring to patients. In Germany, we saw good expansion into the prison setting, with five new prisons initiating treatment with Buvidal in the quarter. In Australia, we maintain our leadership position in the long-acting buprenorphine segment and continue to see growing patients on Buvidal. There has also been structural changes in the treatment system in Australia, with one positive result being a reduction in the co-pay for many patients, and this has the potential to see more patients enter treatment. Buvidal was also launched in Italy in Q3 by Molteni, our distribution partner, who have wide experience in the addiction space, with an already established commercial team. We continue to expand into other markets and have four regulatory and four pricing submissions under review, and other markets are under assessment. Now, moving to the US. As already mentioned, Brixadi was launched into the US market in September by our licensee, Braeburn, and already progress has been made and leading indicators are positive. Braeburn have a sizable and focused commercial team in field at launch, with more than 100 people across sales, marketing, market access, and alongside the medical affairs team. All 50 states have access to Buvidal as of beginning of October, with good prospects for obtaining unrestricted access with both Medicaid and private payers. As already mentioned, in Q3, we received our first royalty payment of 1.2 million SEK for the first three weeks of sales. To remind you, the market opportunity in the US is significant, with an estimated 6 million people suffering from opioid use disorder, of which 1.8 million are in treatment. The market dynamics are positive, with increasing funding, improved, and improved legislation to make treatment more accessible to patients. Brixadi has a unique position in the US market. It's the only product with weekly and monthly formulations, has flexible dosing aligned to current clinical protocols, and an indication for initiation of treatment after a single test dose of sublingual buprenorphine. Additionally, the product attributes of low volume injections, small needle, multiple sites for injection, and room temperature storage are other advantages. In summary, with a strong product profile and the sizable commercial team in place, the prospects for a successful launch are good. On that, I'll hand back to Fredrik. Thank you, Richard. So, over to a brief update on our lead R&D program, 2029. As you've heard previously, CAM2029 octreotide subcutaneous depot is being developed for the treatment of three rare disease indications. Acromegaly, a rare growth hormone disease. Gastroenteropancreatic neuroendocrine tumors, GEP-NET, is slow-growing tumors in the gastrointestinal system. And polycystic liver disease, where there is currently no treatment available. The product, that is CAM2029, is designed for enhanced efficacy and patient convenience. Our three phase 3 programs for CAM2029 are extensive and have progressed well in the quarter. We completed the randomized placebo-controlled AcroInnova-1 study of CAM2029 in acromegaly patients, delivered positive top-line interim phase 3 results from the long-term AcroInnova-2 study, and accelerated recruitment in the randomized SORENTO trial of CAM2029 in patients with GEP-NET. Aim of this largest ever prospective randomized controlled study with a Somatostatin analog is to demonstrate superiority in Progression-free survival with CAM2029 versus standard of care. We believe that would be very valuable. Finally, we made also good progress in the POSITANO trial of CAM2029 in patients with PLD. The expected timelines for the different programs are outlined in the slide. Going forward, in acromegaly, we are preparing for the submission of the NDA for CAM2029 around the year end. This follows two positive pre-NDA meetings held with the FDA, where we aligned on strategy and content for the submissions, including chemistry, manufacturing, and controls, non-clinical and clinical information. Following the NDA, we also plan to submit Market Authorization Application to the European Medicines Agency during the first half of next year. In GEP-NET, we are aiming to randomize the last patients during the fourth quarter, reaching our target of 302 patients. The primary endpoint will be read out when 194 progression events have occurred and been documented. Following this important milestone, we expect to submit the first regulatory application in GEP-NET sometime in 2025. This is the current estimate. In polycystic liver disease, we plan to complete recruitment around the end of the year and have top-line results early 2025. Alongside the significant progress in our clinical programs, we continued our work to establish our own commercial organization in the US. Ongoing activities include establishment of the distribution model in the US, building medical affairs and market access teams, updating market research, and developing our US framework. I'm pleased to report that we are on track to be launch-ready for the planned US approval in acromegaly in the fourth quarter, 2024. So in conclusion, Camurus had a successful third quarter with strong operational performance, resulting in strong growth of Buvidal in our markets. It's actually the 19th consecutive quarter with unrelenting quarter-on-quarter growth. Brixadi was launched in the US, which of course, was a major event for us. We received positive phase 3 results for CAM2029 in acromegaly, and continued to improve our sustainability, performance, and ratings, ending the quarter with a solid financial position. With this, I would like to thank you all for listening, and let's go over into the question and answer session. Can we please, Einar, can you take over the call? Yes. If you wish to ask a question, please dial star five on your telephone keypad. The first question comes from the line of Susanna Queckburner from Handelsbanken. Please go ahead. Your line is open. Hello, Susanna Queckbörner here, Handelsbanken. I wanted to start with a question regarding your experience with genetic obesity disorders, specifically, your licensing partner, Rhythm Pharmaceuticals product, CAM4072. I'm curious to hear how... Your view on, on different modes of action to target obesity, and, and could it make sense to apply the FluidCrystal technology for this class of drug? So, I mean, if we're talking about the program by Rhythm, of course, our technology is already being applied. But I guess you're talking in more the broader context of GLP-1s and GIPs and so forth. Is that the question? Yes. Yes, I think, I mean, I cannot comment on our internal development, but I think that we have shown that the FluidCrystal technology is applicable to peptides, and these are typically peptides, I mean, a size range where the technology is useful. So, in that sense, I can say that and confirm that there are, of course, potential with the technology. Thank you. Then maybe as a follow-up, you've mentioned before that down the line you will announce further products. Perhaps, can you give me a sense of what kind of indications do you think are the most opportune for the FluidCrystal technology? Which conditions would benefit most from improving dosing frequency in a chronic setting or and what weighs into your decisions here when you choose an asset? I think, I mean, if we're historically, of course, we have always been focused on the medical need aspect and the possibility of improving treatment for patients, both in a strictly individual and more broad perspective. Going forward, of course, we have a focus in certain areas, and I think that would make sense for us to focus our efforts there. I mean, if you're looking at diabetes, for instance, that is not an area where or obesity, more general, where we have the resources to commercialize product. That doesn't mean that we couldn't develop products. So I think we are looking at the number of different components when selecting programs, and, but I cannot go into them in more detail right now. Thank you. I'll get back in the line. ... The next question comes from the line of Viktor Sundberg from Nordea. Please go ahead, your line is open. Yeah, yes, hi. Thank you for taking my questions. So first, on the report that you mentioned in your quarterly report here from the House of Commons, any idea when this could be implemented in a more formal recommendation that Buvidal should be considered as a first-line option in the UK for opioid use disorder patients? I also wonder, is it considered a second-line alternative at the moment, as in France, or how is it pushed in the UK for the moment? Thanks. Yeah, thanks for the question. I mean, it depends which region you're in, in the UK. So in some places, it's already first line, other places, they're still waiting for funding to come through. So the Health Select Committee report, to answer that question, it just reviews the progress, and they've identified the value that the long-acting is bringing. So they're flagging with the government that they should continue to make it available as widely as possible to patients, so they have that as a treatment choice. So it's ongoing, is your answer. It's not as though we're waiting for something to change. It's ongoing already. Okay. Thank you. And secondly, on Australia also, now with opioids, on the PBS instead, what will be the impact here going forward, do you think? As I understand, the transition period has been going on and will go on until thirteenth November for smaller clinics and so on. So after thirteenth November, is that when we should expect to see some potential fluctuations in sales, if smaller clinics potentially would discontinue dispensing Buvidal, or what would be the correct way to look at this? Thank you. I mean, it's a bit, it's not really very clear at the moment. What we do know is, yeah, as you're exactly right, that the system is open in the old way until, for some clinics, until the end of November. So there is potential that some clinics may be breaking some stock in at this stage before they go to the change in the PBS. But I mean, I think the way I look at it is underlying our growth is on track as where we thought it would be, and these are just fluctuations in invoice sales between the quarters, so it won't make a huge difference. I think, I mean, it's fair to say that if we're looking at the potential of this impacting us, that's short term and may come, you know, in association with this change. Yeah. Okay. Yep. As I said, as I said already, I think that there is potential for more patients to access treatment now because the co-pay they're being charged for supervised dosing has been reduced quite significantly. There's a set fee now, so we anticipate that some patients—more patients may come into treatment. Okay. Thank you very much. And, and just a final one here also on the competitive landscape in acromegaly. I just wanted to hear your thoughts on, on Crinetics and its oral drug that had positive results here in the Pathfinder one study. What do you see as the competitive advantage here for, for CAM2029 versus, that drug? Thanks. Yeah, I mean, of course, we are addressing three different indications, but if we're looking specifically at acromegaly, I mean, this is a market that has been completely dominated by injectables up to now. There is a big belief in injectable treatments. It's also convenient because you have to dose it once every month. Of course, there may be, for some patients, a positive view on an oral medication. It does require fasting conditions, but not to the extent that we have seen from Mycapssa. But I think that when we listen to our different clinical contacts in the US or elsewhere, there is a very strong view on a positive view on a self-injectable long-acting product. So, we'll see exactly how this pans out. Going over to GEP-NET, of course, is a different situation because that's there we are the only company developing a product for treatment of tumor control, which is the lion part of this market. So there depends on the indication, but we believe that we are in a strong position. Okay. Thank you very much. That was all from me. Thanks. As a reminder, if you wish to ask a question, please dial star five on your telephone keypad. Yeah, we have one more question from Susanna. Please go ahead. Your line is open. Yes. I wanted to switch to CAM2029. The largest indication is GEP-NET, and this is a superiority trial, much more competitive. You have a 500% higher dose than, I think, regular somatostatin analog. There has been some sort of questioning as how achievable a superiority would be. But that aside, given your regulatory route you're choosing with the FDA, is there a possibility for an approval outside of a superiority trial? Perhaps you can sort of outline how you're thinking about your regulatory submission in GEP-NET- Yeah ... if you don't receive the superior outcome. Yes. I mean, I think first of all, I would say that our, you know, firm view and belief is that we will be able to demonstrate also on the clinical side, this advantage, and that's what we have powered the study for, and we have- our background data is been the basis for this. So, obviously, there are many other advantages with the technology. And discussing this with the agency, I think will be on the basis of solid data. I cannot give you an exact answer how that would pan out, but I can say that there is a very good response to the treatment in the studies, and I think that's a positive indicator. But, I would like to stress still that our emphasis and focus is on demonstrating superiority. Thank you. There are no more questions at this time, so I hand the word back to you, Fredrik. So, if there are no more questions, then I would like to thank everybody for attending this presentation today. It was a great quarter for Camurus, and we are looking forward to providing an update at our next call, which will be Q4. And so thank you very much for listening, and have a great afternoon, everybody. This concludes today's call. You may disconnect your line. Have a nice day.