Thank you, and welcome everyone to today's call, where we will present on our significant progress during the third quarter, as well as on the important updates from the U.S. last night. Before we start, please take note of our forward-looking statements. Today's agenda includes third quarter highlights, progress on the Buvidal launch in E.U. and Australia, we'll update on the U.S. approval of BRIXADI, and also on our advances in the R&D pipeline. We'll finish off with some key takeaways and of course, a Q&A session. With me in today's call is Eva Pinotti-Lindqvist, Chief Financial Officer, and Richard Jameson, Chief Commercial Officer. Let's start with third quarter business highlights. Slide four, please.
We had indeed a very positive third quarter with significant progress with Buvidal in the E.U. and Australia, as well as in our key pipeline programs. Our third quarter revenues increased by 105% to SEK 40.2 million in Q3, compared to the same quarter last year. Product sales were SEK 19.5 million, 73% higher than the previous quarter, due to accelerating Buvidal growth. We continue to open up new markets and gain new pricing and reimbursement approvals in five additional markets. In the U.S., in July, the Federal District Court ordered the FDA to reconsider Braeburn's application for full approval of BRIXADI. Last night, we received decision from the FDA, which I'll come back to briefly, in the next slide.
We also continue to build our already strong scientific evidence base, with the completion of the treatment in the DEBUT and UNLOC-T clinical studies. This is really exciting, I think, and, and I'll also talk about that later, in this presentation. We had good progress, in our clinical program for CAM2029, with the start of the phase III long-term safety study. So we now have two phase III studies ongoing in acromegaly. Finally, we signed a new license agreement with Ra Pharma for long-acting subcutaneous FluidCrystal, injection depot, which further demonstrates the utility of our unique and validated technology. We continue to guide total revenues in the range of SEK 130-160 million for the year, with product sales in the range of SEK 70 million-SEK 90 million. So back to last night's news.
We finally received a response from the FDA on the ongoing legal processes in the U.S. Firstly, we received the positive confirmation that FDA had granted Braeburn citizen's petition, and that the orphan designation for Sublocade is now revoked. Braeburn now has a clear timetable for launch of BRIXADI in the U.S., and as you know, this will trigger a $35 million milestone for Camurus. The FDA did not change their decision on the three-year exclusivity for Sublocade, ending November 2020. This is unfortunate, however, we do not expect this to have a significant impact on the market potential for BRIXADI over time. We do have a strong and clearly differentiated product, which is getting fantastic feedback from the market all around. So that's the situation in the U.S.
Let's move over to Camurus market and the significant progress we have had with the launch in the E.U. and Australia. For this, I will pass over the presentation to Richard Jameson. Thanks, Richard.
Thank you, Fredrik. Can we move on to slide seven, please, now? So, as many of you know, we designed weekly and monthly Buvidal to fit with current clinical practice, while addressing many of the unmet needs faced by patients with daily medication, such as the burden and stigma of daily dosing and that need for safeguarding against misuse and diversion. On Slide eight, we can see we set a clear launch strategy, for E.U. and Australia, based on timings for final regulatory steps and the pricing and reimbursement approvals in each market. The launch of Buvidal in our wave one market is progressing well, with a focus on the many differentiating attributes of Buvidal to establish it as a new first-line treatment option in opioid dependence, and I'll come back to this in a moment.
We have now launched in seven markets with our high-performing teams and effective distribution in place, and now have the first national clinical guidelines published in Australia. So in more detail on Slide nine, we can see progress on the launch. We've already covered the significant increase in revenue between Q3 and Q2, driven by the uptake in our wave one markets. We've now got an estimated 2,500 patients currently on treatment with Buvidal, with strong sales in Finland, growing sales in Germany, Sweden, Denmark, and England. Progress was made in Q3, with five additional markets we expanded to, with the pricing and reimbursement approvals of Buvidal in Australia, in Norway, Scotland, Wales, and Northern Ireland. We're seeing excellent patient uptake in the early stages of these markets...
The very positive feedback from patients and healthcare professionals continues, and it's inspiring to hear the significant contribution that Buvidal is making to people's lives. If we move on to Slide 10, we're seeing in-market and patient physician responses are well in line with our robust and growing scientific evidence base for Buvidal, including a high retention rate in treatment and excellent patient feedback, as I've mentioned. We're seeing an increasing number of publications on this real-world evidence across the market. At this stage, I'll hand back to Fredrik to talk about our medical and scientific progress. We move on to Slide 11.
Well, thank you very much, Richard. It's very encouraging to see the progress of Buvidal in our markets and the positive, most importantly, I would say, the positive impact that we are having on patients and all people in interest here. An important element of the success is the many scientific collaborations and strong partnerships that we have established with the treatment community. The high interest and support we are seeing from scientists across the world, it's reflected in our many publications and the study presentations of Buvidal at the international conferences across our markets and internationally. And as an example, at the recent international addiction meeting in Lisbon, Buvidal was featured in several oral presentations, one symposium on long-acting injectables, and one plenary lecture.
I think consistently in all these presentations, in all these scientific congresses, we have had a number of oral presentations and, you know, high-quality presentations overall, including symposia. Next up now is ISAM in which this year is in New Delhi, India, where we have a big symposium on the launch progress in or on the progress of implementing Buvidal in Australia, as well as new qualitative research on the effect of Buvidal on patients. Let's move to the next slide, Slide 12. We have a strong evidence base, which we are continuing to building for Buvidal, with important innovative clinical studies. As I spoke last time, we are having two studies that are being finalized. One is the Depot Evaluation with the buprenorphine Utilization trial called DEBUT.
It's a prospective, randomized, open label trial. 120 adult patients, outpatient, randomized one to one, to Buvidal versus standard of care. Here we have database locked in October, and top-line results will be delivered in Q4. The primary objective of this study is to look at patient satisfaction, quality of life, health economical outcomes, and other patient-reported outcomes. I'm very excited about this study, as well as the second study that is being completed in Australia called UNLOC-T, where we are studying Buvidal in prisons, eight prisons across New South Wales in Australia, and comparing the treatment of Buvidal with methadone. This study will deliver preliminary results in Q4 2019, and already, there was some very interesting presentations about the baseline data, for instance, at least on eviction.
I think both these studies will contribute to our evidence for this treatment significantly in the future. We can go to the next slide, please. I think it's worth to note that Buvidal is the only long-acting buprenorphine depot that has been studied so far, head-to-head against standard daily treatment, and that we have demonstrated superiority. That's a very important differentiation. We are continuing this work through the randomized debut study, where, as I said, we have the top-line data coming in Q4, and the study in the prison setting UNLOC-T versus methadone. We're really creating a strong, strong evidence base here. In addition, we have multiple externally sponsored collaborations ongoing, as well as investigative-sponsored studies, not only in Europe and Australia, but several studies being sorted out in the U.S.. Next slide, please.
We'll go over from here, having discussed Buvidal, to looking at our pipeline. We can go to the next slide, please. As you know, we have a diversified late-stage pipeline in a number of chronic indications, including pain, endocrinology, oncology, and cardiovascular disease. In chronic pain, we are preparing meetings with health authorities for our planned MLA submission first half of 2020. For our long-acting octreotide somatostatin, we now have three phase III—two phase III studies up and running. Next slide, please. CAM2229, we believe, has the potential to address very important unmet needs in acromegaly and endocrine tumors. CAM2029 has orphan designation in acromegaly, not in neuroendocrine tumors, though this is the larger indication. This could be the first octreotide depot for self-administration by patients, significantly improving convenience and also reducing overall healthcare costs.
Also, through the five times higher bioavailability and fast onset, there is a potential for improved efficacy in both acromegaly and NET. In addition to those two indications, we are actually exploring at an additional number of positive, promising, indications, and disease areas for CAM2029. The market is substantial currently, as somatostatin analogs are selling for more than $2.6 billion, and they've had a steady market growth for the past 20 years, as you can see. Going to the next slide. I think this is very interesting. We have, over the last course of this quarter, done a lot of, interesting market research or actually commissioned this, to a third party, both for, acromegaly and NET. And as you can see, there are substantial markets for both indications.
We have sized these markets depending on the profile or the properties of the product, as well as the clinical data. We have three different scenarios, one where we have our prefilled syringe set up only, as well as one where we have also the auto-injector included, and a third scenario including both the auto-injector and the superior efficacy endpoint from the study. Depending on these different scenarios, we have estimated potential peak sales in the range of SEK 300 million-SEK 1.26 billion, depending on product profile. As you can see, this is a very significant opportunity for us, one that we are now looking very much into and where we have done significant progress on the clinical side. Going to the next slide, please. This is the current program.
We have already completed three phase I studies, both single and multiple dosing, one, two, phase II study, which provided very positive, indications of efficacy both in neuroendocrine tumor patients and acromegaly. We have also now then started two phase III studies, one placebo-controlled phase III study in, somatostatin analog responders, and one open label long-term safety study, taking all comers, both new to treatment patients and switched patients from the phase III study. In addition, we have done, much of the planning of the next phase III program, and that has been progressing well. Regulatory submissions for acromegaly are planned, in, in the transition between 2021 and 2022. Next slide, please. Camurus, we are actually building an endocrinology franchise based on CAM2029, but also related somatostatin analog assets that we have in development.
Our lead indications are acromegaly and NET, and as you saw, we have a very significant market potential in both indications. But we are also looking into both the third and the fourth indication here. In addition to that, we have conducted a phase I, successful phase I program for a setmelanotide FluidCrystal depot, and are also working with a somatostatin FluidCrystal depot. Both have interesting potential due to a different somatostatin receptor interaction profile. So with that, we can go to the next slide, please. In addition to our significant program progress in the phase III program for CAM2029, we have also seen some interesting progress in our collaborations and partnerships. We have an ongoing phase II study with the setmelanotide FluidCrystal weekly subcutaneous depot, which is being developed by Rhythm for treatment of genetic obesity disease.
And aside from that, Rhythm actually reported positive phase III data for the daily formulation in both POMC, which is proopiomelanocortin patients and leptin deficiency patients. Those, that report was delivered in August 2019. So we have strong support for efficacy of setmelanotide in these indications. In addition to that, we signed a new license agreement with Ra Pharma directed at complement mediated disorders, and this is zilucoplan FluidCrystal SC depot, a long-acting formulation then, for treatment of generalized myasthenia gravis, as well as immune-mediated necrotizing myopathy, and other serious complement C5 mediated disorders. We have preclinical proof of concepts here, as you can see in this graph here, and we are preparing, or Roy is rather preparing for start of clinical studies next year.
The license agreement was signed in July 2019, and interestingly, later on in October, Ra Pharma was actually acquired or agreed to be acquired by UCB for $2.5 billion, which was a significant premium over the current per-share price. So with that, I think we can go to the last slide here in our presentation. We have had a very productive, as you can see, an eventful third quarter. We have made good progress in all key areas and shown very robust growth in E.U. and Australia, driven by increasing patient shares and really great feedback from patients and good launches in new markets. We have received new reimbursements in key markets and new applications are progressing. BRIXADI is now on track for a 2020 launch in the U.S..
We have two phase III acromegaly studies of CAM2029 initiated, and plans for neuroendocrine tumor studies are progressing alongside an auto-injector development. Preparations of CAM2038 for chronic pain MAA submission for H2 progressing, and we have had good, good, good collaborations and also a new license with Ra Pharma. In addition to that, we also have new patent filing for our improved crystal technology platform and a number of interesting new drug candidates in the early pipeline. Our net revenue increased by 105% during the quarter to SEK 40.2 million. Operating loss was SEK 77.4 million, and our cash position at the end of the quarter was SEK 192 million. So with that, I'm happy to open up this call for questions together with my colleagues here, Richard and Eva, in our billing team.
Thank you for listening.
Thank you. Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad. Our first question comes from the line of Peter Sehested from Handelsbanken. Please go ahead.
Yeah, hi, it's Peter from Handelsbanken. Thank you for taking my questions, and congratulations on the uptake of Buvidal. I have three questions, if I may. It's regarding the development of CAM2029, the decision to go with an auto-injector and how that decision will, let's say, impact the overall timelines for the program, because I assume this is valid for both acromegaly and NETs, and also with respect to NETs, also a timeline for that project as well. That was actually the second question. My third question, just an update on the milestone that you were actually expecting from Braeburn in case of approval in the U.S. Thank you very much.
Oh, thank you, Peter. Yeah, so when it comes to the auto-injector development, that is going on in parallel with the phase III program, and we are planning to have bridging studies. So will it be a bridging PK study? And so it will be, according to the current plan, available on launch in acromegaly, and it will also be introduced into the NET development. So when it comes to the clinical trial in neuroendocrine tumors, we have been working very intensively together with our biostatisticians and key opinion leaders on the design of the program. We are intending to do a superiority study against active comparator, and I think we have good grounds for that. And currently, the timeline for start of that study is somewhere, I would say, around the mid of 2020.
Okay.
In terms of your last question, could you please repeat that?
Yeah, the last question-
Oh, yes. Okay, yes, so the milestones from Braeburn. So, yes, I mean, the milestones from Braeburn, they are, of course, due on approval. So we are expecting from a cash flow perspective, they will be slightly delayed, but we are expecting that, you know, on approval, the end of this year, or the coming year, of course, 2020.
Yeah, in November 2020. But can't really remember whether you have communicated a size for that-
Oh, the size. So yes, it's-
Yeah
... $35 million , $35 million is the milestone payment for weekly and monthly approvals.
Okay. Thank you. Now that that milestone is not available until a year's time, looking at your burn cash position, et cetera, I mean, you are flagging that you are delaying, you know, startup of some projects, phase II starts, et cetera. But is there anything else that we should be aware of in terms of internal timelines? And can you finance all the timeline that you have flagged in your Q3 report with the current state of the balance sheet? Thank you.
Yeah, I just want to say first of all, of course, that, I mean, we are, you know, keeping tight control of our finances. I think that's important to say. And, I'll leave this over to my colleague, Eva, our CFO, please.
Yeah, right. Yeah, as you say, we have a lot of the potential, attractive development opportunities coming up, and, with our growing revenues and the planned spend that we have, we are on track for positive cash flow late 2020. And, for these effective development opportunities, it might be, as you say, we obviously have limitations to finance these right now.
Yeah, and all of them, that is.
Mm-hmm.
Okay, so you plan to be able to deliver on your current state, you know, milestones with respect to the pipeline, with the sort of, you know, the current cash and the projected cash coming in from revenues?
That's correct.
Yes.
Okay. That was it. Thank you very much. Thanks for taking my question.
Thank you, Peter.
The next question comes from the line of Harry Sephton from Jefferies. Please go ahead.
Hi there. Thank you for taking my questions. I have four, please. So firstly, on the BRIXADI case, now that we have some clarity around when the monthly can actually be approved, what are your expectations around the potential for the weekly indication being launched ahead of that, and any milestone payments associated with that as well? My second question, clearly in Finland, you've had an extremely successful market. What has really worked for you there? I remember you've previously said that that's particularly easy market access compared to maybe Germany and the U.K., but how do you think you can maybe replicate the success there in some of your other markets? My third question is, what is the latest in Australia following the AUD 40 million of investment in the PBS listing?
Did you see any material sales there in the third quarter, and are you expecting that to significantly ramp up in the coming quarters? And then, on CAM2029, you mentioned that you're also maybe looking to add some additional indications for that product. Could you maybe be a little bit more specific on those? Would those potentially be indications which are typically associated with somatostatin analogs, or are you looking to have a differentiated indication there? Thank you.
Thank you. Thank you, Harry. Yeah, on the first question with regards to, the weekly and early, a potential early approval of the weekly, I just want to say that, you know, we got the news from the FDA very late last night, so we have not had a detailed discussion so far, with Braeburn. I can say that they are seriously, considering the option of launching the weekly early, but it's still subject to their, review, but I think that should clearly be regarded as a possibility, and a good one as well. But we will come back to that when we have some more clarity, from our partner.
With regards to Finland, I mean, yeah, it's clearly a success in terms of patient share, and it's actually even a larger success in terms of market share, of course, because of, you know, the price difference between Buvidal and the current products on the market. So yeah, that's a clear case. And we do see similarities on other markets. So already we see both Norway, Australia are showing very similar trends, and I think those trends are due to the fact that you don't have a lot of hurdles in the market. Richard, you want to comment that, or?
Yes. I mean, it's when we have reimbursement in Norway and Australia, it's on the very central level, and then there's no price discussions at a local level at all, so we see rapid uptake in both those markets.
Yeah, to your question, do we have any material sales yet in Australia? All we can say is that it's picking up very nicely. I think that's the main message from us on that front. And finally, in terms of potential additional indications for CAM-2029, as you know, I mean, octreotide is being used in a range of different indications, and you know, it's got demonstrated efficacy in a number of clinical studies. We have assessed, I should say, from start, 10 potential indications, and we have narrowed that down to 4. I don't think that some of them are perhaps not obvious. We will not disclose that today, but we have done a very significant work together with an external partner, and we'll come back to that shortly.
But, I mean, some of them are definitely in areas, in well-known areas, and others are perhaps a little bit outside the beaten track, but there are significant opportunities, market opportunities, in those indications. And I think we have also mentioned some of them in our previous correspondences, but I think for the time being, that's a good point. Anything else, Harry, or you're happy with that?
No, that's, that's extremely helpful. No, thank you.
Just a reminder, if you do wish to ask a question, please press zero one on your telephone keypad now. As there are no further questions, I'll hand it back to the speakers.
Okay, I just want to say then that thank you everybody for listening in to this call. I think that we really thank you for your following Camurus, and we look forward to giving you updates as we progress here over the next quarter. It looks very promising and I'm looking forward to meeting you at the regular meetings, and also wish you a very nice weekend, everybody. Thank you.