Camurus AB (publ)

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. Certainly been a good quarter for cameras. 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 John Garay, our Chief Financial Officer, and Richard Jameson, our Chief Commercial Officer. As you may already have seen in this morning's report, CAMRS delivered a strong third quarter performance. resulting in very positive financial development with high double-digit revenue growth to 384 million SEK in the quarter and 1.3 billion SEK year-to-date. Our operating result was 104 million SEK in the quarter and 554 million SEK year-to-date, including also costs for three extensive phase three programs. Our cash position increased to 1.15 billion SEK, including a 35 million US dollar 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 bid-out sales grow by 44% year-on-year to 346 million SEK in the quarter. In the US, our licensee Braeburn launched Brixadi for treatment of opioid use disorder, which was of course an important highlight. And 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 three 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. And with this, I'll leave over to John for a financial update.

Thanks a lot, Frederik, and good afternoon, everyone. We would like to share key highlights of our financial performance this quarter. Camorus achieved 384 million SEK total revenue in the quarter, delivering a growth of 59% versus same period last year, with product sales of 346 million SEK, growing 44% versus prior year, and 13% versus prior quarter. Additionally to product sales, Camurius recognized 25 million SEC revenue related to the expiration of Breborn's option period for Buvidal in China, Japan, Korea, and Taiwan. And by first time, Bricsadi's sales in the U.S. represented a 1 million SEC royalty income following its commercial launch on September the 5th. Company achieved an earning per share after dilution of 1.5 Swedish kronor, equivalent to a profit after tax of 86 million SEK in the quarter. Finally, company cash position at quarter end was 1.15 billion SEK, 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 basic points versus same period prior year, which is driven by supply chain efficiencies as bubital volumes scaled up. On a year-to-day basis, product gross margin was 90.4%, representing 135 basic points improvement versus the first nine months of prior year. Total OPEX reached 253 million SEG, representing a 37% increase versus same period prior year, driven by following three factors. Marketing and distribution investment to support market penetration in owned territories and expansion of bubidal into new markets grew 41%, Administrative expenses aligned with corporate evolution to substantiate company development were flat versus same period last year, and R&D investment reached 148 million SEG, growing 39% versus same period prior year, driven, on one hand, by progress in our ongoing three phase three trials, mainly recruitment progress in NET and PLD, and on the other hand, breed out of AcroInnovature top-line results. Company operating result as a consequence became positive by 104 million SEC in the quarter. If we now move to next slide, company cash position at quarter end was 1.15 billion SEC. Camurus generated half a billion SEC cash in the quarter driven by following three factors. Firstly, company operations generated 121 million SEC. Secondly, working capital improvement drove $365 million SEG, driven by collection of Rizadi milestone following FDA approval in Q2. And thirdly, exercise of warrants program delivered $17 million SEG cash. As 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 due to expectations, Kamuru's guidance for total revenue was increased to the range of 1,640 to 1,720 million SEK from prior range of 1,530 to 1,650 million SEK. With profit before taxes estimated in the updated range of 525 to 600 million SEK, from prior range of 425 to 525 million SEK, and company is on track to deliver the long-range plan vision shared at Capital Market 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, John. So, I will give a brief update on the strong progress in cameras markets and an update for the US following the first three weeks of the launch of Brixadi. So if we start with the cameras markets, Q3 was another strong quarter for our teams in Europe, Australia and the MENA region. Our net sales reached for 346 million sec, which is 44% up against the same period last year and 13% ahead of Q2. We had underlying strong in-market performance with additional positive contributions from current exchange rates and also some stocking 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, and 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. And 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. And in Australia, we maintain our leadership position in the long-acting ruponorphine 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. Buberda was also launched in Italy in Q3 by Montaigne, our distribution partner, who have wide experience in the addiction space with a 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 U.S. As already mentioned, Brixardi was launched into the U.S. market in September by our licensee Braeburn. and already progress has been made and leading indicators are positive. Braeburn have a sizeable and focused commercial team in field at launch with more than 100 people across sales, marketing, market access, and alongside a medical affairs team. All 50 states have access to Buvidal as of the beginning of October with good prospects for obtaining unrestricted access with both Medicaid and private payers. I'd already mentioned in Q3 we received our first royalty payment of 1.2 million SEC for the first three weeks of sales. And 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. Brixardi has a unique position in the U.S. market. It's the only product with weekly and monthly formulations, has flexible dosing aligned to 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 root temperature storage are other advantages. So in summary, with a strong product profile and a sizable commercial team in place, the prospects for a successful launch are good. And on that, I'll hand back to Fredrik.

Thank you, Richard. And so over to a brief update on our lead R&D program, 2029. As you've heard previously, Chem 2029, OctuTime subcutaneous depot, is being developed for the treatment of three rare disease indications. Acromegaly, a rare growth hormone disease, gastroenteropancreatic neuroendocrine tumors, GEPMET, is slow growing tumors in the gastrointestinal system, and polycystic liver disease, where there is currently no treatment available. The product, that is CAMP2029, is designed for enhanced efficacy and patient convenience. Our three phase three programs for CAM 2029 are extensive and have progressed well in the quarter. We completed the randomized placebo-controlled ACQUIRINOVA-1 study of CAM 2029 in acromegaly patients, delivered positive top-line interim phase three results from the long-term ACQUIRINOVA-2 study, and accelerated recruitment in the randomized SIRAMTO trial of CAM 2029 in patients with GAPNET. The aim of this largest ever prospective randomized control 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 mda for camp 2029 around the year end this follows two positive pre-mda 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 Medicin Agency during the first half of next year. In GetNet 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 GetNet 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 framework. I'm pleased to report that we are on track to be launched ready for the planned US approval in Acromegaly in the fourth quarter 2024. So in conclusion, Canberra's 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. Brixari was launched in the US which of course was a major event for us. We received positive phase 3 results for Camp 2029 in Akromegaly and continue 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 Quekburner from Handelsbanken. Please go ahead. Your line is open.

Hello. Susanna Quekburner here, Handelsbanken. I wanted to start with a question regarding your experience with genetic obesity disorders, your licensing partner, Rhythm Pharmaceuticals product TAM 4072. I'm curious to hear your view on different modes of action to target obesity and could it make sense to apply the fluid crystal 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 in the broader context of GSP ones and gifts and so forth. Is that that's the question.

Yes.

Yes, I think, I mean, I cannot comment on our internal development, but I think that we have shown that the food crystal technology is applicable to peptides and these are typically peptides and in 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. And 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 fluid crystal technology? Which conditions would benefit most from improving dosing frequency in a chronic setting and what ways into your decisions here when you choose an asset?

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 makes sense for us to to focus our efforts there. I mean, if you're looking at diabetes, for instance, that is not an area where, or obesity in 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, 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 Victor Sundberg from Nordea. Please go ahead. Your line is open.

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 buvidol should be considered as a first-line option in the U.K.? ? 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. 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, you think? As I understand, the transition period has been going on and will go on until 13th November for smaller clinics and so on. So after 13th November, is that when we should expect to see some potential fluctuations in sales if smaller clinics potentially would discontinue dispensing Vividol or what would be the correct way to look at this? Thank you.

I mean, it's not really very clear at the moment. What we do know is, as is exactly right, that the system is open in the old way for some clinics until the end of November. So there is potential that some clinics may be making some stock in at this stage before they go to the change in the PBS. But I mean, I think the way to 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.

But I think it's fair to say that if we're looking at the potential of this and impacting us, that's short term and may come in association with this change.

Yeah, as I said already, I think that there is potential for more patients to access treatment now because the copay they've been charged for supervised dosing has been reduced quite significantly. There's a set fee now, so we anticipate that more patients may come into treatment.

Okay, thank you very much. And just a final one here also on the competitive landscape in acromegaly. I just wanted to hear your thoughts on Krenetics and its oral drug that had positive results here in the Pathfinder 1 study. What do you see as the competitive advantage here for Chem 2029 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. And there is a big, what's it say? 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 reCAPSA. But I think that when we listen to our different clinical contacts in the US or elsewhere, there is a very strong view, a positive view, on a self-injectable long-acting product. So we'll see exactly how this pans out. In going over to GetNet, of course, it's a different situation because there we are, the only company developing a product for treatment for tumor control, which is the lion part of this market.

um so so there depends on the indication but we believe that we're in a strong position okay thank you very much that was all for me thanks as a reminder if you wish to ask a question please dial star 5 on your telephone keypad you can have a brief pause to see if yeah we have one more question from susanna please go ahead your line is open yes um i wanted to switch to account 2029

The larger indication is DIPNET, and this is a superiority trial, much more competitive. You have a 500% higher dose than I think regular somatostatin analogs. There has been some sort of questioning as to how achievable this superiority would be. But that aside, what given your regular given the um regulatory route you're choosing with the fda um is there a possibility for for an approval outside of a superiority trial perhaps you can sort of outline how you're thinking about um a submission your your regulatory submission in gitnet if you don't receive the superior outcome yes i mean i think first of all uh i would say that our

in a firm view and belief is that we will be able to demonstrate also on the clinical side this advantage and that's what we empowered the study for and we have our background data has 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 that our emphasis and focus is on demonstrating superiority thank you there are no more questions at this time so i hand the one back to you frederick so uh if there are no more questions then i would like to thank everybody for attending this presentation today it was a great quarter for cameras 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