Welcome to Camurus Q2 Report 2023. During the questions- and- answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now I will hand the conference over to CEO, Fredrik Tiberg. Please go ahead.
Thank you, Einar. Good day, everyone, and thank you for taking the time to joining our second quarter earnings call today, which I'm happy to note was our strongest quarter yet. Before starting the presentation, please note our forward-looking statements here. The agenda for today's earnings call includes a summary of second quarter highlights. We'll go through the financial results, followed by commercial and pipeline updates, as usual, then finish off with a Q&A. With me on today's call is Jon Garay, our Chief Financial Officer, Richard Jameson, Chief Commercial Officer, and also Alberto Pedroncelli, our Chief Medical Officer. The second quarter was really strong across the board for the company and transformative. We continued the commercial execution, building on our leadership in opioid dependence treatment market with Buvidal.
Net sales increased to 305 million SEK in the quarter, an increase of 36% against last year. In parallel, we continued market expansion with regulatory and market access processes and approvals, and on the pipeline development side, we achieved several major milestones in the form of the long-awaited FDA approval of Brixadi in the U.S., and positive top line phase III results for CAM2029 in acromegaly, the ACROINNOVA 1 study. We reached two-thirds recruitment in our GEP-NETs trial, SORENTO, and after the period, we announced positive phase III data from the second phase III trial of CAM2029, ACROINNOVA 2. On the corporate development side, we note record revenue and results. Six consecutive quarters now with positive operating results. We recognized the $35 million milestone for the approval of Brixadi and got our U.S. subsidiary, Camurus Inc. operational.
In summary, it was really an exceptional quarter for Camurus, where we delivered above our own expectations. With that said, let's move over to the financial review. Please, Jon.
Thanks a lot, Fredrik. Good afternoon, everyone. We would like to share with you now the key highlights of our financial performance this quarter. In the second quarter, Camurus achieved 674 million SEK total revenues, delivering a growth of 197% versus same period last year, with product sales of 305 million SEK, growing 36% versus prior year and 8% versus prior quarter. Brixadi approval by FDA triggered a one-off $35 million milestone revenue, which was recognized as income in the quarter. Operating result for the quarter was 376 million SEK, which means a 369 million SEK improvement versus same period last year.
Company has achieved an earning per share after dilution of 5.24 SEK , equivalent to a profit after tax of 301 million SEK in the quarter. Finally, our cash position at quarter end was 654 million, which is a 53% improvement versus same period prior year. If we now move to next slide, we can see the main components of our operating result. Gross margin reached 95.7% in the quarter, driven by $35 million milestone revenue, triggered by FDA approval of Brixadi in the U.S. Excluding this.
We seem to have lost the speakers. We will pick them up again in a second.
Not sure. We had a break here.
Now we have the speakers back on Fredrik's phone. Yes.
Yeah. Okay. Yeah. Where did you lose us?
In fact, I'm not sure. Start over from the last slide. Yep.
Which, which slide are we talking about, Einar?
I think you were just in for like, 3 minutes.
Please move to start with strong cash flows.
Yeah, Jon had started speaking, yes.
Okay. Do we start from profit and loss? Anyway, let's go back to profit and loss. We, now in this slide, we can see the main components of our operating results. Gross margin reached 95.7% in the quarter, driven by $35 million milestone, approval of Brixadi in the U.S. Excluding this one-off milestone, company gross margin reached 90.5% in the quarter, representing an improvement of 157 basic points versus same period prior year, driven by supply chain efficiencies, as well as our volumes scale up. On a year-to-date basis, and excluding Brixadi one-time milestone, company gross margin was 90.2%, representing 167 basic points improvement versus the first six months of prior year.
Total OpEx reached 270 million SEK, representing a 38% increase versus same period prior year, driven by following four factors: Marketing and distribution investment to support market penetration in own territories and expansion of Buvidal into new markets grew 32%. Administrative expenses, aligned with corporate evolution to substantiate company development, grew 38%. R&D investment reached 161 million SEK, our highest ever R&D investment, growing 39% versus same period prior year, driven by progress in our ongoing three phase III trials, mainly ACROINNOVA 1, top-line results, readout, and recruitment progress in net. Other OpEx were minus 3 million SEK, driven by valuation of currency hedging contracts at quarter end. Company operating result became positive by 376 million SEK in the quarter.
Excluding Brixadi one-off milestone, Camurus reached a positive SEK 8 million operating result with the highest ever investment in R&D. If we now move to the next slide, our cash position at quarter end was SEK 654 million, delivering a 53% growth versus same period prior year. Brixadi milestone will be realized in cash in the third quarter. As it is neutral from cash flow point of view, in this quarter, we are excluding it in the waterfall we are showing for transparency purposes. Camurus generated SEK 68 million cash in the quarter, driven by following four factors. Firstly, company operations generated SEK 38 million. Secondly, working capital improved by SEK 29 million. Thirdly, exercise of warrant programs delivered SEK 6 million in cash. Finally, company invested SEK 5 million in technological activities. As end of quarter, Camurus has no debt.
All in all, Camurus closes second quarter 2023 with a solid financial and operational position, having achieved the first two milestones of 2023, and continue showing interesting growth opportunities. Camurus reiterates its 2023 financial outlook, expecting total revenues and profit before taxes in the mid to high end of current guidance, and is on track to deliver the long-range plan vision shared at Capital Market Date 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'll start with an update on Europe and Australia. We're pleased to share the continued positive momentum with Buvidal in Q2, built on the organic growth across our markets. As already mentioned by Jon, sales for the quarter were 305 million SEK, up 36% year-on-year and 8% quarter-on-quarter. The estimated number of patients grew from about 39,000 patients to above 42,000, a net increase of 3,000 patients spread across our different markets. We saw continued good revenue growth in the Scandinavia, Finland, UK, Spain, and Australia. And Australia, where the growth has offset the recent government price decrease. There was a positive trend shift also in Germany, which grew over 30% versus Q2 last year. We continue our market expansion and have 4 HTA and 4 regulatory submissions under review.
In Austria, we've received a new reimbursement status that allows improved patient access to treatment with Buvidal. Additionally, we saw continued strong momentum in the criminal justice system, with new guidelines published in Sweden and Belgium recommending Buvidal as a first-line treatment in prisons and expanded use in this setting in the U.K. Now moving across to the U.S. As you already know, on the 23rd of May, we received the positive news that the FDA had approved Brixadi for the treatment of opioid use disorder in the U.S., with a positive statement from the FDA recognizing the expansion of dosing options to help patients to stay in a long-term recovery. Brixadi is well-differentiated in the long-acting injectable market and is expected to play a role in addressing the significant unmet needs of patients with OUD in the U.S.
It's unique in having both weekly and monthly formulations and flexible dosing align with current practice and can be given through multiple injection sites. It's easy to switch to or from current daily buprenorphine treatments through a dose equivalence table. Brixadi is the only long-acting injectable that can be initiated from day one for those coming into treatment. With small volume, small needle, and room temperature storage, it's simple to use and easy to store. We're now looking forward to the upcoming launch in the U.S. of Brixadi. This is planned for September and will be conducted by our U.S. licensee, Braeburn. Braeburn has informed us they are well-prepared with the commercial organization, including having a sales force in place.
From a market dynamics perspective, the launch is well-timed, as there's increasing funding becoming available for OUD treatment and new legislation introduced to expand patient access to treatment to help address the issue around the opioid crisis. Based on this positioning, we believe Brixadi has a peak potential of above $1 billion . Camurus is a significant part of the financials, and we're looking forward to this successful commercialization by Braeburn. On this note, I will hand back to Fredrik for an update on the pipeline.
Thank you, Richard. As you have realized here, there has been some technical glitches outside here, but I'm trying to proceed accordingly. Over to a pipeline update, focusing on the top-line results of the two phase III trials of CAM2029. As a background, CAM2029, referred to as octreotide SC depot, is being developed for the treatment of 3 rare disease indications. These are acromegaly, gastroenteropancreatic neuroendocrine tumors, and polycystic liver disease. The product is designed for enhanced efficacy and patient convenience. We have an extensive clinical program ongoing with CAM2029, which includes three phase III trials in acromegaly and neuroendocrine tumors, and one phase II/III trial in polycystic liver disease. All of these have really progressed nicely during the quarter. However, I will focus the presentation on the recent positive results of the two ACROINNOVA trials.
Despite the availability of several medications for treatment of acromegaly, there remains an important unmet medical need in the area. These include limited biochemical control of patients with acromegaly, often around 50% to around 50% of the population is full responders. Persistent symptoms like fatigue, headache, paresthesia, and soft tissue swelling, as well as joint pain. Another unmet need is the complexity of present medications and the lack of convenient dosing options for self-administration of current first-line treatments. Finally, impaired quality of life is something acromegaly patients often experience. As you can see on the right-hand side, acromegaly patients report significantly worse quality of life outcomes than healthy controls, and similar to patients with obesity, who are known to have significantly compromised quality of lives.
With this as a background, let's move over to the phase III trials and our new top-line results. We will start with a quick review of the results from ACROINNOVA 1, which was presented just a couple of weeks ago. This was a 24-week randomized controlled trial of CAM2029, with the aim to demonstrate superiority versus placebo. The trial randomized 72 patients on stable treatment with standard of care, two to one, to treatment with CAM2029 or placebo. The primary endpoint of the trial was responder rate for normalized insulin growth factor one levels. A key secondary endpoint was responder rate for both IGF-1 and growth hormone, GH. Further secondary endpoints included patient satisfaction, quality of life, clinical signs and symptoms, as well as self and partner administration, and of course, safety.
As presented in our press release in June, ACROINNOVA 1 met both primary and key secondary endpoints with high statistical significance, showing superiority versus placebo. Importantly, the main results were confirmed by all pre-specified sensitivity and supportive analysis, as well as several secondary endpoints demonstrating the robustness of these data. This is, of course, very important when we come later on to our regulatory submissions and the review processes. The significant treatment differences in biochemical control was further shown by the difference in the time to loss of biochemical response between the two treatment arms. For CAM2029, the median time to loss of response was not reached, while for placebo it was about eight weeks.
The Cox regression analysis of these data showed a hazard ratio of 0.1, which you can say simplistically means that it is 10x more probable to lose control when receiving placebo treatment compared to treatment with CAM2029. This was statistically significant with a p-value of less than 0.001. In addition to improved biochemical control, ACROINNOVA 1 also showed some other interesting outcomes, including statistically significant improvement in several patient-reported outcomes. Here we show the acromegaly quality of life for CAM2029 versus standard of care at baseline. As you can see in the forest plots, there are significant improvements in the quality of life with CAM2029 compared to standard of care. This is seen for the total AcroQoL score, which is the measure here, as well as for the physical and psychological domain scores.
Significant positive treatment differences were also seen in patient satisfaction and treatment satisfaction outcomes. This is noteworthy considering that the patients, at baseline were on stable treatment with current standard of care and biochemically controlled. In summary, the ACROINNOVA 1 trial met both primary and secondary endpoints of superiority versus placebo and showed that IGF-1 and GH and symptoms were well controlled over time. Quality of life and patient satisfaction were statistically improved versus standard of care at baseline, and CAM2029 had a well-tolerated safety profile in line with first-generation somatostatin receptor ligands. With this brief review, I will move over to presenting some of the highlights of the ACROINNOVA 2 study, which we announced top-line results for only yesterday.
This was a phase III open label long-term safety and extension trial, which included 81 new patients that were on stable treatment with standard of care but had variable degrees of biochemical control, so variable degrees of treatment success, you could say. As well as 54 patients that rolled over from ACROINNOVA 1 after 24 weeks of treatment with CAM2029 or placebo. The placebo patients were regarded as treatment naive in this context and were, of course, very interesting to follow. The primary endpoint of the study is safety and tolerability of CAM2029. Important secondary endpoints included biochemical response, clinical signs and symptoms, tumor size, patient and treatment satisfaction, and again, self and partner administration. Here, I will only present top-line results. Starting out with the demographics, here shown as the overall patient population and by patient group.
The characteristics of the enrolled patients were overall representative of the acromegaly population in real-life setting and were spread across EU and the rest of Europe, with about 10% of patients coming from the US. The primary outcome of the ACROINNOVA 2 study is safety. We will start there. The safety profile of CAM2029 is consistent with a well-established safety profile of first-generation somatostatin receptor ligands, octreotide LAR and lanreotide ATG. Most adverse events, vast majority were mild or moderate, grade 2, and only a few were severe, grade 3 or higher. None of the severe events were related to the study medication. Only one serious adverse event was reported as related to study medication in the trial. This was a case of gallstones, which was moderate in severity and resolved spontaneously.
2 patients discontinued treatment due to adverse events, and 1 patient had an adverse event relating to dose that resulted in dose reduction, I should say. Overall, the long-term safety profile of CAM2029 was regarded as favorable, with no new or unexpected findings. Moving over to efficacy, here starting with the biochemical control of patients. As you can see in the slide here, we saw significant improvement in Insulin-like growth factor 1 normalization after 52 weeks of treatment with CAM2029, compared to standard of care at baseline. For the overall population, we saw an increase in IGF-1 response from 49.7%- 58.5%, an increase of 8.7% from baseline.
For new patients in ACROINNOVA 2, who were on stable treatment but with low rate of biochemical control, the response rate increased from 12%- 32%, which is a more than twofold increase compared to baseline. For treatment-naive patients previously treated with placebo, that is in the ACROINNOVA 1 trial, the response rate increased from 20%- 93% after switching from placebo to CAM2029, an increase of 74%. While for rollover patients who were treated with CAM2029 in ACROINNOVA 1, biochemical control remained stable throughout the trial, demonstrating long-term efficacy. Overall, the data show that CAM2029 is effective in achieving biochemical control across patient populations with different treatment histories. Focusing on the patients rolling over from ACROINNOVA 1 to ACROINNOVA 2, where there's quite some interesting things happening.
You can see in the top graph, the mean IGF-1 concentrations over time when going from standard of care at baseline to CAM2029 in ACROINNOVA 1. Then to CAM2029 in ACROINNOVA 2. In the lower graph, the corresponding response rates are shown. Essentially, what you see is that IGF-1 levels are elevated during placebo treatment and effectively suppressed on CAM2029. This is also mirrored by the response rate. Notably, patients coming from placebo rapidly regain IGF-1 control when receiving CAM2029, which is a very important feature, of course. Over to another finding of the study and looking at symptoms, it was a notable outcome of the trial that they have significant improvements seen in acromegaly symptoms over time when switching patients from stable treatment with standard of care to treatment with CAM2029.
Here, this is illustrated by the decrease over time of the Acromegaly Index of Severity score for patients treated with CAM2029. While patients treated with placebo or receiving placebo, showed a trend towards worsening symptoms and then improving again when switched to CAM2029. The results of the ACROINNOVA 2 trial are quite compelling, reinforcing the favorable safety profile of CAM2029, showing improved IGF-1 response in overall uncontrolled and treatment-naive populations, and stable response in controlled patients. An important top-line findings were the improved symptom control seen both in patients having any symptoms as well as the AIS score that I referred to earlier. We also saw increased treatment satisfaction and improved quality of life.
Based on the positive top-line data received, we believe CAM2029 can offer an important option for patients with acromegaly, and we are confident that the data will support our regulatory applications and the future commercialization of CAM2029. Aside from the success with the ACROINNOVA program during the period, we reached the milestone of 200 patients randomized in the SORENTO trial, which aims at demonstrating superior progression-free survival with CAM2029 in gastroenteropancreatic neuroendocrine tumors versus standard of care. We remain on track to enroll the rest of the approximately 100 patients in the second half of the year, which I think is a very strong achievement once it happens. In polycystic liver disease, recruitment continued in the POSITANO trial, with close to 50% of patients now being enrolled in the study.
We expect to enroll the rest of the patients before the end of the year. Besides the significant progress in our clinical trials, we have accelerated a number of other activities in the quarter. This includes preparing regulatory submissions for CAM2029 in acromegaly, starting the buildup of a U.S. commercial infrastructure, and ramping up our medical affairs activities, including participation in key conferences and preparing new scientific publications. Our medical team has been expanded with key expertise and leadership, led by our new Chief Medical Officer, Alberto Pedroncelli, with extensive global expertise in both acromegaly and neuroendocrine tumors. I look forward to reporting more on these topics in the forthcoming calls.
I will just go over to the key takeaways of the second quarter, and I must say it's a pleasure to report an outstanding second quarter here with record revenue and earnings, FDA approval of Brixadi, strong market growth of Buvidal, and positive results from two phase III trials, as well as other clinical milestones achieved. With that, thank you for listening, and we will move over to questions- and- answers. Thank you, everybody.
If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. Our first question comes from the line of Suzanna Queckbörner from Handelsbanken. Please go ahead. Your line is open.
Hello, Suzanna Queckbörner, Handelsbanken. I have three questions. First of all, you booked a $35 million milestone payment from Braeburn as revenue for this quarter, but it appears you haven't received the payment, as it's been booked as a receivable in your balance sheet. When would you expect the actual payment from your partner to come through? Perhaps you can talk about the timeline here. Second question is, perhaps you could give us a broader update on the austerity measures. You briefly mentioned it with regard to Australia. I noticed that sales growth wasn't as high in Oceania, Australia here, and also the revenue per patient seems to be coming down further.
Thirdly, perhaps you could give a little bit more detail on this trend shift that you observe in German Buvidal sales. Is this a consequence of changes in doctor remuneration reimbursement, or is the 30% year-over-year growth just from a low base and a potential one-off?
Yeah, please, Jon.
Thanks a lot, Suzanna. Regarding your first question, the $35 million will be collectible during Q3. When we issue the press release for the FDA approval, we will inform that it will be collectible upon invoice, but it will be issued either 90 days after FDA approval or when the first commercial sale will take place. Hopefully, we expect to get it in Q3.
Well, the sooner of those two events.
Yeah.
Yeah.
Okay.
And the-
The second one is Buvidal austerity measures.
Yeah, the austerity measures, I mean, we've seen a small price cut in Australia. Actually, our underlying business in Australia is still strong. It's grew 11% in volume, quarter-on-quarter, and I think something like 29% year-on-year. The underlying growth, remember, that's from a strong base as well, is still growing well. Yes, it's offset by that austerity measure in Australia that we saw from the government.
The third one is the revenue per patient.
The revenue per patient, we think is reasonably stable at the moment, apart from, of course, the impact of that Australian cut. Well, the other one was Germany, was it?
Yeah.
The other question around Germany. Yes, we did see, we had a strong quarter. You're right, Suzanna, it's a mix of all those. I think one of the things is the penetration we're seeing in the prison setting. We haven't seen a change in remuneration yet. We know there's a lot of talk about it going on at the moment, and a proposal that's being considered. Most of this growth is coming from the prison setting at the moment, where we're focusing on because it's not impacted by those measures.
Suzanna, are you?
Okay.
Any more? Are you fine?
Yes. That's great. Thank you very much.
The next question comes from the line of James Vane-Tempest from Jefferies International Limited. Please go ahead. Your line is open.
Hi, thanks for taking my questions. Just a couple on Brixadi, please. Congratulations on the approval. Is there any information you can share either on the size of the sales force or what the pricing strategy will be, and commercial strategy? Thank you.
Thank you, James. I mean, I think, we haven't gone out with anything specific on the sales force. We are, I say, content with the size. We think that it's well-dimensioned for the purpose. That's what I can comment on there. In `terms of pricing, Braeburn has not officially announced their pricing strategy. I think we will keep it at that for the moment, unless you have some specific questions. I think that's the most I can provide at this stage.
Thank you.
No more questions from James. The next question comes from the line of Patrik Ling from DNB Markets. Please go ahead. Your line is open.
Hi, guys. Can I have a follow-up question on pricing per patient? When I just do my calculations on the average price per month per patient, it's roughly around EUR 220-EUR 19, which is down a little bit since Q1, but it's down quite significant from what you historically has reported. Maybe you can elaborate a little bit if this is sort of a price range that we should expect going forward, and whether there are more really than just those certainty measures. I mean, especially maybe if you compare to Q4 and previous quarters, that has impacted price.
Patrick, I think overall, we haven't had any significant price decreases to the, you know, the past few quarters. It's been quite consistent. There is, of course, always some changes between quarters in terms of the country mix, which can have an impact, and it will probably vary up and down. I would say that we are quite consistent in our pricing over the quarters the last year at least, or more. What we have referred to is, of course, the Australian price decrease of 5%. However, this was, you know, well compensated for by volume increases. We do not see this difference. I think it's more or less a country mix question. Maybe, John, do you have any further?
Fully align with you, Fredrik, just one small note. You refer to a revenue per patient in euros. Our reporting currency is Swedish kronor, and we have our analysis done in Swedish kronor. Perhaps you are impacted by the precision of the Swedish kronor when converting Swedish kronor to euros. In case of our analysis, fully align with Fredrik, we do not see any change in the revenue per patient.
Okay. I usually look at just roughly the average number of patients per quarter and the average euro rate per quarter to get it into Swedish kronor. I mean, when you look at it, what would you say is the current run rate, approximately? I know that you have talked about that prices might come down when you get a little bit different mix of countries where you sell your product in. But in your mind, where's the rough price per patient today, whether you will have it in Swedish kronor or in euro or any other currency?
Well, I think you can just calculate it on basically a year's basis. It's not changed significantly since last year. We don't give a specific price indication unfortunately. It's both difficult and we have not given that before, but basically, you can use the kind of annual price range. As we said, there has been very little changes since 2022. Anything more, Jon?
No, it's fine.
Yeah.
Okay, great. Thank you, guys.
There are no more questions from the teleconference at this time, I hand the word back to you, Fredrik. We have one more question. I'm not sure from who it is. We'll check. Please state your name and company before asking your question. Please go ahead.
Yes, hi, this is Viktor Sundberg from Nordea. I think something happened when I was kicked out of the conference call with the technical issues. I had a questions on the CAM2029 and just on Ipsen here, that was very vocal about its auto-injector program last year for Somatuline Depot to protect its franchise mostly against generic competition. If this would be launched in 2024, could it impact your launch of Budose pen formulation, or what is your market intelligence telling you about this potential competitive threat, let's say, in acromegaly? And maybe also comment, if this Ipsen auto-injector is launched, what do you see as competitive advantages for your pen formulation? Or does this technology level the playing field a bit here to CAM2029? Thanks.
That's a good question. I mean, if you're looking at it overall, first of all, I haven't heard any news on that development, and so it was a press release for a few, a year back, I think, at least. That's the information that I have at this moment. I mean, the problem and the complexity of that development is significantly higher than ours because of the different delivery modes. If you look at the product lanreotide, it's a very highly viscous paste, and it requires, what should I say, special solutions. I think the system that they had chosen to develop with this is a much more technologically advanced system.
It's, it's a very different system to the one we are using here. Phillips- Medisize, it's called. I think from a complexity standpoint, it's very different, and also cost-wise. We do have a standard of state-of-the-art auto-injector, and we have shown in clinical trials that it is, you know, highly functional and also appreciated by patients. I think for us right now, we don't have any understanding of the whereabouts of the other development, and we don't believe at this point that it will impact us.
Okay, thank you. That actually brings me to the next question, which is more on the bigger picture here. I think a quite recent review listed around 25 FDA-approved products based on polylactic glycolic acid, or I guess, polymer-based long-acting technologies. Some of them were med tech tilted, perhaps. My point here is that, given your studies to date, I guess there is now plenty of evidence that your lipid-based FluidC rystal technology is just a better long-acting technology if you put it head-to-head against the polymer-based ones, especially against, say, Sublocade or Sandostatin LAR, et cetera.
I just wanted to understand why we couldn't view Camurus as a company disrupting this technology, and that lipid-based long-acting technology should be the preferred alternative going ahead here when you want to develop a long-acting drug, whether an existing drug or a new drug, maybe outside of antibodies, of course. A long question here, I guess, I wanted to understand if you share this view or if my thinking here is a bit flawed, and what kind of polymer-based products could be next for you to go after? Thank you.
Well, I think it's a good suggestion and, you know, one that we are trying to pursue, of course, and we have multiple programs ongoing, both in the clinic, but also a lot of new things happening in our early pipeline. This is really the direction we want to go. I would like to say, though, and stress that, of course, every technology has its advantages and some disadvantages, and they are kind of adopted for different purposes. I think you are right in the comparison on most aspects, and we see a lot of opportunity going forward.
We also have in, aside from our own developments, we have a number of partner programs in early development phase, as well as up to phase III, as you know, with Rhythm Pharmaceuticals. Certainly this is the direction we want to go, and we are also developing our technology for new delivery modes and new active ingredients. That's definitely another important line of business that we are taking.
Okay, thank you. Also, perhaps if I could get in a final question. You talked previously perhaps about, you know, going the M&A route to acquire a commercial organization for CAM2029, but today you communicate much more that you want to build your own organization. I was wondering if that's off the table now or if you're considering both options when thinking about how to commercialize CAM2029, if that would be approved. Thank you.
Yeah, I think that's a very appropriate question. I mean, our idea was from the beginning to go both paths, because obviously you cannot decide to find a partner. We have pursued both directions, and we will continue to pursue them. Of course, the longer we come in our own preparations, the less kind of relevant is the pure question about finding an external commercial organization. On the same time, of course the more relevant is, you know, adding new potential assets to our commercial build-up, and both in our current existing market as well as in the U.S. I think, you know, we are definitely pursuing this direction and continue to pursue it going forward.
Thank you very much.
Now there are no more questions from the teleconference, so I hand the word back to you, Fredrik.
We have some questions coming from the web. Fredrik, we have one question here from Corey Jubinville that is speculating about the if we have aligned with the FDA regarding the definition of treatment-naive patients and how that can potentially translate into a label, future label.
Well, we have had discussions, of course, with the agency. On that particular questions, we have no specific alignment, based on other discussions, we believe that this is a feasible way forward in terms of demonstrating the efficacy of CAM2029 in naive patients. It's a very good substitute for having naive patients in the study. Overall, we have a clear alignment with the agency in regards to the registration program and the clinical trials, and they are synchronized.
That was all from the web.
If there are no further questions, I would just like to wish everybody on the call a very nice summer. If you're in Australia, of course, it's a different season, but nevertheless, I look forward to the update we will have during the autumn and of course, also, meeting you again in the Q3 call. Thank you very much and have a lovely one, summer, everybody.
This concludes today's call. Have a nice day.