Welcome to Camurus Q4 Report 2023. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing pound five, pound key five on their telephone keypad. Now, I will hand the conference over to CEO, Fredrik Tiberg. Please go ahead.
Thank you so much, and good day, everyone. Thank you for joining our earnings call today, where we'll report on the progress made by Camurus during the fourth quarter and full year 2023. Please be aware of our forward-looking statements. The agenda for today's presentation is as follows: We'll start with a summary of the full year and Q4 highlights. Then we will move into financial results and the guidance for 2024, followed by commercial development and R&D pipeline updates. We'll finish off, as usual, with key takeaways and a Q&A. With me on the call today is Jon Garay, our CFO, and Richard Jameson, Chief Commercial Officer. So 2023 has been a very successful and transformative year for Camurus, with solid performance across the business.
We continued to strengthen our leadership position in the treatment of opioid dependence across our markets, and we're pleased to see the U.S. launch of Brixadi gaining momentum with a strong uptake of patients in the fourth quarter. Our pipeline continued to advance with several important milestones achieved, including positive results from 2 phase 3 trials in the ACRINOVA program. Following this, we submitted an NDA for Oclaiz in acromegaly to the U.S. FDA and are awaiting their acceptance letter. Aside from the operational progress, we delivered a strong financial performance in the year. This is reflected in a strong growth of both revenues and results in 2023, continuing the trend seen from the first Buvidal launch in 2019. We expect this positive development to continue during the coming years, as outlined in our five-year vision from 2022.
In this slide, we have summarized the progress in the four pillars of our 2027 vision. Firstly, on the fivefold revenue increase target, we reached SEK 1.7 billion, and are on track to deliver on our goal of SEK 4.5 billion. Patients in treatment with Buvidal reached nearly 50,000, and Brixadi was launched in the U.S. with expected peak sales beyond $1 billion. We also progressed our work to establish an own commercial infrastructure in the U.S. As you may have seen in the press release earlier this week, Behshad Sheldon has been appointed President for our Camurus U.S. operations, with responsibility for the launch of Oclaiz. Thirdly, we advanced the R&D pipeline towards the goal of 4 new approvals. Firstly, with the approval of Brixadi in May, and then the NDA submission for Oclaiz in December.
Finally, we also have an ambitious, an ambition to reach around 50% operating margin in 2027. We achieved 31%, and going forward, we will continue focusing on our operational excellence and disciplined capital allocation. As you know, we additionally continued evaluating synergistic inorganic growth opportunities. To strengthen our transaction capability and flexibility, we recently raised SEK 1.1 billion in a directed share issue. So all in all, we are on track to deliver on our 2027 vision, and with this, I will leave over the word to Jon for a financial update.
Thanks a lot, Fredrik, and good afternoon, everyone. As Fredrik mentioned, Camurus continued its growth journey during 2023, and now we will share with you the main highlights of our financial performance in the quarter and in the year. Camurus achieved SEK 375 million total revenue in the quarter, delivering a growth of 40% versus same period last year, with product sales of SEK 366 million, growing 37% versus prior year and 6% versus prior quarter. Additionally, Brixadi sales in the U.S. represented an SEK 8 million royalty income in the quarter, following its commercial launch on September last year. Looking at full year results, Camurus reached SEK 1,717 million total revenue, representing a growth of 80% versus prior year.
This amount included SEK 406 million, one-time milestone and license revenues, mainly related to Brixadi approval in the U.S. Brixadi royalty represented SEK 9.5 million in 2023. Company achieved an earnings per share after dilution of 7.5 Swedish kronor, equivalent to a profit after tax of SEK 431 million during 2023. Finally, company cash position progressed positively during the year, ending at SEK 1.2 billion, representing a 110% improvement versus prior year. ... If we now move to next slide, we can see the main components of our profit before taxes. Company gross margin reached 91.3% in the quarter, representing an improvement of 175 basis points versus same period prior year.
The improvement was driven by three major factors: firstly, supply chain efficiencies, driven by Buvidal volume scale-up, represented 120 basis points. Secondly, 20 basis points are driven by Brixadi royalty. And thirdly, FX represented 35 basis points. On a full year basis, company gross margin reached 92.9%, with product gross margin at 90.7%, representing 146 basis points improvement versus prior year. Total OpEx reached SEK 371 million, representing a 67% increase versus same period prior year, driven by following factors: marketing and distribution investment to support market penetration in own territories, expansion of Buvidal into new markets, and our recent US operations grew 43%. Administrative expenses, aligned with corporate evolution to substantiate company development, grew 82% versus same period last year.
R&D investment reached SEK 230 million, growing 70% versus same period prior year, driven by recruitment completion in NET, PLD progress, and ACRINOVA last site closing and CSR finalization. Our OpEx were impacted in the quarter by a material SEK 51 million accrual related to social security costs of company long-term incentive programs as a consequence of 73% share appreciation. Finally, Swedish krona appreciation in the quarter provoked an unrealized loss of SEK 12 million. On a full year basis, company profit before taxes reached SEK 549 million, growing SEK 476 million versus prior year. If we move to next slide, company cash position at quarter end was SEK 1.2 billion. Camurus generated SEK 36 million cash in the quarter, driven by following factors.
Firstly, company operations generated SEK 38 million, a proof of the strong operational performance in the quarter. Secondly, working capital increased by SEK 8 million, driven by sales growth. And thirdly, exercise of warrants program delivered SEK 14 million cash. Finally, other factors, including translation, required SEK 8 million cash. At end of quarter, Camurus has no debt. After the closing and in January, company raised SEK 1.1 billion via a directed share issue subscribed by a group of high quality international and local institutional investors. The subscription price was determined through an accelerated book building procedure. Let's now move to 2024 financial guidance. From a top-line point of view, company has considered the following factors when providing 2024 revenue guidance.
One-time milestone revenues of SEK 406 million in 2023, driven by Brixadi FDA approval and Camurus regained rights to certain Asian territories for CAM2038, will not repeat in 2024. Market conditions in current macroeconomic environment, based on partner bank analysis, include a negative FX impact of around 3%, driven by anticipated Swedish krona appreciation during 2024. As a consequence, we expect company revenues in the range of SEK 1,740 million-SEK 1,860 million, equivalent to a growth, excluding 2023 one-time milestone revenues, of 33%-42%. Importantly, we continue our double-digit business growth during 2024.
From a bottom-line point of view, company has considered continued investments to support the strategic vision 2027, including R&D will stay approximately flat versus 2023 in the level of SEK 600 million, incremental commercial investment of approximately SEK 300 million to establish our own U.S. operation, global launch preparations for CAM2029 in acromegaly, and commercial preparations for NET. Finally, social security costs regarding company long-term incentive programs may temporarily fluctuate and could be material during the first half of 2024. As a consequence, we expect company profit before taxes, in the range of SEK 330 million-SEK 450 million, equivalent to 131%-215% growth versus 2023, excluding one-time milestone revenues.
All in all, Camurus closes 2023 with a strong financial position, solid operational performance, interesting growth opportunities, and is on track to deliver the long-range plan vision. Having said that, I would like to pass the word to Richard. Thank you everyone for your attention.
Thanks, Jon. So I will give a brief update on the continued progress of Buvidal in Camurus markets and the US update following the launch of Brixadi in September 2023. So let's start with the Camurus markets. Q4 saw our continued progress with Buvidal expansion in Europe, Australia, and the MENA region. Our net sales reached 366 million SEK, which is 37% ahead of the same period last year, and 6% ahead of a Q3, which included some one-time orders from distributor markets. Within this, versus Q3, Europe was growing at 5% and Australia, MENA at 8%. In the full year, we reached 1.3 billion SEK, growing 39% over 2022. And we estimate there are now about 48,000 patients being treated with Buvidal during the quarter.
Growth in the quarter was across all our markets and includes U.K., especially as funding is reaching the clinics, alongside additional progress in the criminal justice setting as the NHS supports the uptake of Buvidal. Australia, we continue to penetrate the market, and the changes in the market following the government review seem to be creating a positive impact and expanding access. In Germany, expansion, notably in the prison setting, is continuing and in the Nordics, where we still have good growth on top of already high penetration. We're seeing accelerated growth in the newer markets, led by Spain and France. Also, alongside our commercial execution, we continue to expand into other new markets and deliver on our lifecycle management plans. In Q4, we obtained regulatory approval in another MENA market, Kuwait, and had the 160 mg approved in New Zealand.
Additionally, there are further four regulatory and several pricing submissions under review. That's Europe. We can now move to the U.S. Brixadi was launched into the U.S. market by our licensee, Braeburn, in September, and momentum is strong, as evidenced by the growing royalty income of SEK 8.3 million in the quarter. Braeburn informed us that this early progress is a result of the strong product profile for Brixadi in a country with a high unmet medical need. The focused launch strategy and execution with a commercial team of more than 100 people. The messaging around Brixadi, like Buvidal, is compelling and completely clearly resonating with U.S. HCPs.
Payer coverage is on par with other long-acting products in OUD, and there's a good channel development that provides quick and reliable access to Brixadi through a dedicated network of specialty pharmacies, distributors, and independent pharmacy chains. Based on this positive start, Braeburn is optimistic that Brixadi will achieve peak year sales of well over $1 billion, which interestingly corresponds to a market share below the one that Buvidal holds in many of the markets in Europe and Australia. In summary, we've seen a good start in the U.S. and a clear opportunity for significant growth. We also continue to build the evidence base of Buvidal and share this across the globe at relevant congresses and symposia, of which the main ones are outlined on the slide.
Recent publications from the quarter have provided further support for the profile of Buvidal, Brixadi, and the need for innovations in the opioid dependence landscape. These include the need for flexible and individualized dosing, the opportunity that long-acting buprenorphine can give patients to increase social engagement that lead to employment, education, and training, and also a better understanding of why users do not enter treatment, and how new treatment options that address the limitations of daily treatment will encourage more individuals to seek treatment. In summary, we've continued good progress of Buvidal in Camurus markets. We've got gathering momentum in Brixadi in the U.S., both of which are supported by a growing evidence base and scientific communications. With this, I hand back to Fredrik.
Thank you so much, Richard. Over to an update on our late-stage pipeline programs. We have continued to advance 2029 across the three target indications: acromegaly, gastroenteropancreatic neuroendocrine tumors, GEP-NET, and polycystic liver disease, PLD, where there is currently no treatment. The product is designed for enhanced efficacy and patient convenience. Based on the data that received so far, we are increasingly enthusiastic about the potential of CAM2029 across these indications. As you know and have heard previously, we have a comprehensive ongoing clinical program for CAM2029. This comprises of two phase 3 studies in acromegaly, a randomized placebo-controlled study called ACRINOVA-1, and a long-term safety and efficacy study called ACRINOVA-2. In addition, we have a large randomized, active controlled phase 3 trial in gastroenteropancreatic neuroendocrine tumors called SORENTO. Finally, a phase 2-3 study in patients with polycystic liver disease called POSITANO.
All have made excellent progress during the period, including results and patient recruitment. Starting with acromegaly, we got positive results in the two phase 3 trials last year, demonstrating a high grade of biochemical and disease control during treatment with CAM2029 and favorable symptom control. Both studies reported improved patient-reported outcomes for symptoms, treatment satisfaction, and quality of life of patients versus standard of care at baseline. This is, of course, a high bar. A population pharmacokinetic and pharmacodynamic model have also been developed and is being included in our NDA and EMA filings. This is predicting plasma concentrations of octreotide as well as biochemical response for IGF-1 for CAM2029. Finally, based on positive pre-NDA and meetings with the FDA, we completed and submitted the NDA for Oclaiz, the U.S. trade name for CAM2029, in December.
We are expecting a formal acceptance from the agency in the near term and a PDUFA date, which is expected to be in this, the fourth quarter this year. If approved, we believe CAM2029 will offer significant benefits to patients with acromegaly. This includes being the first long-acting product in the U.S. and offering convenient once-monthly self-administration for patients with an easy-to-use prefilled pen, which can change the point of care for patients. Delivering improved convenience and treatment satisfaction versus current standard treatments, and the high bioavailability of CAM2029 is expected to provide and shown to provide for persistent biochemical and improved symptom control. Finally, the ACRINOVA studies showed improved quality of life in acromegaly patients treated with CAM2029 compared to standard of care. This is, of course, important as acromegaly patients generally have a low quality of life.
We will work closely with the agency, FDA, and look forward to bringing CAM2029 to patients. In addition to acromegaly, we reached a significant milestone of completing the phase 3 patient recruitment for our second indication in gastroenteropancreatic neuroendocrine tumors. We have successfully recruited 332 patients globally, exceeding our target of 302. SORENTO is thereby the largest randomized controlled study ever performed with a somatostatin receptor ligand in neuroendocrine tumors, as well as other indications. The goal is to demonstrate superiority for CAM2029 versus standard of care. So in this image, we have the SORENTO study design, and following the full recruitment in the study, we are now monitoring patients for progression-free survival events to reach 194 events required for reading out our primary endpoint.
We are currently expecting this to occur sometime between the end of 2024 and mid 2025. In the PLD program, we also made good progress. The POSITANO trial moved forward. We recently randomized the last patient in the study to treatment with CAM2029 or placebo. The primary endpoint of the trial is liver volumes change, and the key secondary endpoint is polycystic liver disease symptoms, measured using our own patient-reported outcome tool, PLD-S, which we have developed in close connection with the US FDA. Top-line results from the study are expected in Q1 2025, and during the period, the open label extension of the trial was increased by two years to monitor treatment effects and allow patients who have completed the main part of the trial to continue benefit from treatment with CAM2029.
In summary, we have a very strong momentum in the overall 2029 program, with multiple milestones expected in the next two years. From a commercial aspect, Camurus to Camurus, CAM2029 is of course, very, very interesting, and we intend to take the product to market ourselves in all key geographies. We have concentrated target audiences across the three indications, a strong differentiated product profile in markets with high unmet medical needs. There is a clear opportunity to switch patients on current first-line treatment to CAM2029 in both the acromegaly and neuroendocrine tumor indications. The market potential across target indications is significant, with peak sales estimates above $2 billion, with the largest opportunity being neuroendocrine tumors and the U.S. market. We have advanced our preparations to establish our own U.S. market organization for Oclaiz. Camurus Inc. is now fully operational.
Behshad Sheldon was appointed this week as President of Camurus US, and also, we are seeing other functions being onboarded. Medical affairs activities are ongoing, and we will have a presence at all key scientific events in 2023. We're also active in the market research, payer engagement, payer interviews, and development of a distribution model to be ready for the planned launch around the end of this year. So to wrap this up, a successful 2023 has built a strong foundation for continued value creation for Camurus.
Continuing through the pivotal growth in our own markets, a positive launch momentum for Brixadi in the US, which I am very happy for... significant pipeline advancement towards new product approvals, progress in the establishment of a US commercial organization, and a strengthened financial position to support our growth. With that, I would like to thank you all for listening, and we'll move over to Q&A. Please, take over the call.
If you wish to ask a question, please dial pound key five on your telephone keypad. The first question comes from Viktor Sundberg from Nordea. Please go ahead. Your line is open.
Yes. Hi, guys, and congrats on a good quarter. So on your guide here for full year 2024, I just wanted to understand what kind of underlying assumptions you've made, especially in terms of maybe Brixadi royalties and maybe any color of what you have assumed for Buvidal in Europe and Australia as well. And in terms of your ramp up to launch, CAM2029 in acromegaly, what number of sales reps do you need to cover that market? I'll start there. Thanks.
Okay. I mean, if we're looking at the Buvidal growth patterns, we are expecting to have a growth that is similar to this year. We haven't announced any sales targets for Brixadi. All we can say is that we are encouraged by the achievements over the first four months. Jon, would you like to say anything more about that in terms of the Brixadi sales development or?
No, it's early stage of the launch. Q4 was reassuring about the potential of the product, and we are working closely with Braeburn to try to figure out. But at the moment, we are not going to disclose these figures. We will do it at least on a quarterly basis as we are seeing the progress in the market.
And then on top of that, can you remind me? I missed the last question you had there?
The number of sales reps in acromegaly.
Oh, yes. So I mean, we are going to have a very targeted sales force, and I would say that, you know, the total commercial organization focused on acromegaly will be less than 50 people. I think that's about the information that we are able to provide right now, and it will be built up mainly in terms of the sales force, mainly during the second half of the year.
Thank you. And then on the patient numbers on Brixadi, you said that Braeburn reported around 2,000 patients on drug at the moment. Any details if these are treatment-naive patients or maybe switches from other long-acting alternatives on the market?
Well, first of all, we have not referred to Braeburn's reporting in terms of numbers. We have used the data that is available in terms of sales in our estimates. And our estimates are that there were more than 2,000 patients in treatment at the end of the year. So that's the main, that's that information. On the following topic, can we say, Richard?
Can you remind me what the question was again?
Can you repeat that again, Victor, the second part of the-
Oh, yeah. I just wondered if these are mainly, if you have that information, treatment-naive patients or switches from sublinguals that you've seen?
That's a good question. I would say that, you know, at this early stage in the process, a majority of patients will most likely be switching either from-
Yeah
... sublingual buprenorphine or some other buprenorphine treatment.
Okay. And then finally, on CAM2029, I just noticed that some of your competitors are going after, you know, carcinoid syndrome as the first phase 3 study after acromegaly. And that also seems to be an obvious candidate for a somatostatin analog. And I believe I just wondered what your line of thinking is here, going for GEP-NET as your first indication, as the first choice.
So first-
And also, if you plan to go into carcinoid syndrome-
Yeah
... down the path.
First of all, carcinoid syndromes or patients with carcinoid syndromes or functional tumors, it's a small minority of the overall NET indication. So that's the first consideration. Secondly, they are well treated with somatostatin analogs, so they will be well treated, you know, with CAM2029, especially, that's our expectation. We are, of course, looking at any carcinoid syndrome in our patient population, but it's a very small population, and we have, of course, assessed that opportunity and also discarded it. Otherwise, we would have, you know, continued development there. So I think that's my main response. But it is a small minority and generally speaking, kind of well treated with somatostatin analogs.
Okay. And also, will the pen formulation be on the market at the anticipated approval date in acromegaly in Q4? Will that come along later?
That's a very good question, and no, I mean, it will be available from start. It's part of our filing.
Okay. Okay, thank you very much. That was all for me. I jump back in the queue.
Thank you very much. Victor-
The next question from Sean Hama from Jefferies. Please go ahead. Your line is open.
It's Brian Balchin from Jefferies. Thanks for the questions. I've got a few. So the first is on Brixadi, just the physician feedback, maybe just touching on Victor's question around what you're hearing just in terms of the switches from Sublocade. Then just on that commentary about well above $1 billion, is that an upgrade to what you previously communicated just on the peak sales potential there for Brixadi? And then just on CAM2029 in acromegaly. It would be great if you could help us better interpret that 72% response. Just given feedback I've had that it's not as high as expected, given the fivefold higher octreotide exposure. So I think you mentioned this before being a function of the trial design, as opposed to, you know, patients potentially seeing lower bioavailability on the subcu. I've got an additional on GEP-NET, but I'll just leave it there for now.
Okay. So in terms of the statement about well above $1 billion, so that's, as I said, it, it, it comes from Braeburn, and, and it's Braeburn's view. So, I think it, it's quite aligned with our expectations. And from their side of obviously, it's a sign of strength, at this point. And overall, I, I would say we are very enthusiastic about the early, launch figures and, and the, the data we have received. However, I cannot go into any of those details, but we are, we are very enthusiastic about that. When it comes to the question about the response, in the, phase 3 placebo-controlled trial. So every trial, of course, has a slightly different population. This IGF-1 response is measured.
IGF-1 is a parameter which is, you know, quite- there's quite a distribution in, in, variability in the measurements. But at the outset, to be able to come into the study, you have to pass the screening criteria, which is one time upper, times the upper limit of normal. So that is. You know, we are forced through that, and that actually was resulted in quite a lot of screen failures. But once you're in the study, you know, this criteria is completely relaxed.
So what that means is that just naturally, you will have some patients that were very close and just passed, that are going to be transferred into a, what we call the non-responder state. So it is really an impact of a number of different parameters, but you have to look at the trial like this, more from the comparative angle than the switch angle in terms of the IGF-1, because that was an inclusion criteria. I don't know if that's too technical or, you know, do you see that, or do you want me to follow up, Brian?
No, I think that, you know, that is helpful. Thank you very much. I just have one on GEP-NET. So do you think you can just give us reason to be confident in CAM2029 showing superiority head-to-head there? And then just if you think it can still file, even if you show non-inferiority. And then just thoughts on the impact of radioligand therapy following Novartis GEP-NET study. Thanks.
Okay. Yeah, I mean... So the outset of this is, of course, that we have reviewed all the available published data on low, high exposure octreotide versus normal exposure, so to speak. Also, we have used the studies that were conducted by Novartis on the RADIANT studies, and done sub-analysis there. So there is a significant amount of information. On top of that, I mean, there are some recent, very interesting studies that have demonstrated that when you move from lower than labeled to labeled or higher than labeled doses of octreotide, you have large differences in overall survival, overall cancer survival, I should say. And those increases are, I think, significantly about 50%. We also have discussed this with the authors and so we have a good, let's say, understanding of the data, and it supports our hypothesis that we went into the study with.
Great, that's super helpful. Just one follow-up on, you know, obviously, the stock is a bit down, and admittedly, that's, I guess, partly to do with the flawed 2024 consensus, potentially just not accurately forecasting. And then as well, not baking in kind of that incremental SEK 300 million into SG&A. If you could give some thoughts on that, please.
Just answering the question you had also about before that, about Lutathera. And so I think I want to highlight that, you know, some people think that Lutathera is used as first-line treatment, and that's true, but it's for a different population than CAM2029. So, you know, somatostatin receptor ligands are used early in therapy, and the radioligands are used for more severe patients.... but importantly also, you know, somatostatin receptor ligands are used together with the radioligands, and it's part of the Lutathera label. So, Jon, do you want to comment on the second question here?
So, thanks a lot, Brian. About our market guidance, I mean, on one hand, on the top line, we have trying to be transparent about the one-time milestones. It's public information every quarter in our report, in the financial chapter. And then the effects is driven by the external analysis that we have received from the banks we are working with. On the investment side, the SEK 300 million, we think it is in range. We have been checking our investment levels with peers going into the US. Usually, it's in the range of SEK 250 million. And in reading the analyst reports, I know that some of them, they were considering a similar amount, plus, minus, okay?
In the R&D, during the 2023, we said that our estimate was that 2023, 2024 would probably be the peak years in R&D, and then we would see a slight decline after that. But yeah, in spite of we trying to share this information, you are right, there was a wide range in the estimates of the analyst, and it was affecting the Bloomberg consensus. But our company is the same, our fundamentals are the same, our performance are the same. Some of you, in fact, have recognized our strong performance in the quarter, excluding the one-time hit for the social cost. And we are fully aligned to deliver our 2027 long-range vision. So we are on track to deliver it.
Okay, got it. Thank you very much.
Anything else, Brian, or you are-
That's it. You've cleared up the consensus point, so yeah, that's, that's helpful. Cheers.
Thank you so much.
The next question is from Suzanna Queckbörner from SHB. Please go ahead. Your line is open.
Hi, thank you for taking my question. Suzanna Queckbörne r, Handelsbanken. I just wanted to double down on the consensus question regarding the SEK 300 million. So, how should we think about this going forward? Is this going to span the full commercialization, or should we continue to think further ramp up for SG&A in line with the U.S. operation? And then maybe you can also break it down into to what we're looking at specifically here. That's my first question.
Okay. So, so the SEK 300 million is mainly the, the commercial investment to create the operation into the, into the U.S., Susanna. It has a component that is fixed structure. We need the basics to, to do it, and then it has the sales force and related medical activities to drive acromegaly. When we go into the next indication, NET, we will need again to, to invest in sales force and likely medical activities for NET, and the same for PLD in the future, while the structural piece will remain, will remain constant. Out of the SEK 300 million, you can basically assume that perhaps one-third is structural and two-thirds are related to medical and, and marketing and sales in regarding to, to acro. And, and I think I have, I have addressed your question, Susanna. Anything else?
No, that's great. Okay, so this is acromegaly, but two-thirds, but the structural components will also contribute to the other indications.
Yes, in the structural piece, we are including supply chain activities, we are including legal activities, a portion of finance, HR, everything that it takes to create a running operation in the US.
Great. And then my second question relates to Buvidal. In the report, you started mentioning lifecycle management and how you're considering different options here for Buvidal, different indications. When you said last call that you were going to announce new indications or new pipeline assets, is this what you're referring to? Is this... Maybe give us a little bit of an idea of of-
No, no.
-the novelty.
No, I don't think so, that this was what we were referring to. I mean, in terms of the lifecycle management activities, I mean, we know there is a very significant potential in the methadone transfer, because we have, especially in Europe and Australia, we have a large number of patients that are stuck on methadone, and there has been a lot of ongoing activities there. But that was not when we are talking about new activities. We were not talking about lifecycle management activities. So, we will. I think we have announced that we will. Our plan is to start a new clinical program during the year. We are not ready for various different reasons to communicate that today, but we'll most likely do so later on.
Great, and just to clarify, that would be new, independent of existing earlier-stage clinical programs?
Yeah, I think that's a good assumption. That's our intention.
Thank you. Good. Thank you. That's it from me.
The next question is from Dan Akschuti from Pareto Securities. Please go ahead. Your line is open.
Thank you for taking my questions, and congrats for the great progress across all the programs. One question would be on R&D costs. Is it fair to assume that they will continue to increase a bit now in Q1, but then stabilize thereafter? And the next question would be on the outstanding sales milestones, which, if I recall correctly, are $75 million in total or... And you mentioned you don't expect any of those, anything of that, to be triggered this year, or are they only triggered at much higher sales numbers? Thank you.
So, thank you for your question. If I start with the second part about the sales milestones, we are not including any sales milestones this year. I don't know how to respond to the much higher question, but we have said previously that it's well within the what should I say, reasonable target range, all of the sales milestones. So, I'll stay with that information because that's what we have disclosed publicly. But we don't have any milestone included in this year of material nature. Jon, would you like to comment on the distribution of the R&D costs?
So, so thanks for the question, Dan. So it is difficult to predict the distribution by quarter because we follow the progress of each study. So for example, in Q1 2024, it's already public information that we have completed the enrollment in the POSITANO study, PLD. So subsequently, we will be recognizing the milestone of that, which will be a material amount. But then we depend on the progress to be able to recognize this milestone. So it's difficult for me to tell you if it is going to be flat or how it's going to be. I would recommend you to see the phasing in 2023, if you want to model it by quarter, and it can give you an idea of how we can fluctuate.
But being totally transparent, if we, if we reach the 194 PFS events in NET earlier than we expect, the R&D investment will come earlier, okay? Because it's a direct, it's a direct investment to the progress in the project.
Thank you very much. That's all for me.
There are no more questions at this time, so I hand the word back to you, Fredrik, Jon, and Richard.
Thank you, and thanks, everybody, for listening in, today. I hope that you see that this was a really strong quarter for Camurus, and we are looking forward to providing the next update in the Q1 call. With that said, I'll leave you all to enjoy the rest of the day, and thank you for-