Camurus AB

STO:CAMX

Earnings Call Transcript 2022-Q2

[Operator]

Good day, and welcome to the Camurus Q2 2022 Earnings Conference Call. [Operator Instructions] Please note, this event is being recorded.

I would now like to turn the conference over to Fredrik Tiberg. Please go ahead.

[Fredrik Tiberg, executive]

Thank you so much, and hello, everybody. Thank you for taking the time to joining us this Friday afternoon for our second quarter earnings call. It's a pleasure to update you on the continued progress of Camurus.

Please note our forward-looking statements. And this is today's agenda. With me on the call is Jon Garay, our Chief Financial Officer; and on the phone from Cambridge, U.K., is Richard Jameson, our Chief Commercial Officer.

Before going to highlights, here is a snapshot of Camurus 3 years after the approval and launch of our first transformative medicine, Buvidal. We have gone far proven our commercial execution ability and emerged as a leader in the opioid dependence treatment field, advanced our late-stage pipeline of innovative long-acting treatments targeting high unmet need CNS and rare disease areas with potential blockbuster status and are showing strong revenue growth towards some goal of sustained profitability with further potential upside in our late-stage pipeline and partner programs.

In the second quarter, following a solid first quarter, we entered profitability for the first time as a publicly listed company. We continue to deliver high double-digit year-on-year revenue growth, reinforced our cash position and financial flexibility and raised our guidance for full year 2022 results, from loss to profit at the interval midpoint. We continued commercial execution, resulting in increased patient shares and expanded markets and strengthened our leadership in the opioid-dependence area.

On the R&D side, we progressed our pipeline, including variation in applications for Buvidal in EU and Australia, to extend the indication to include chronic pain. Phase III programs of CAM2029 in acromegaly and neuroendocrine tumors were further progressed. And we started a clinical Phase IIb study of CAM2029 in a third indication, polycystic liver disease. We also caught up on the operational clinical study milestones from the previous period.

Overall it was a productive, successful quarter, thanks to our great teams and collaborations. With these introductory words, I hand over to Jon for a review of our financial performance in the period.

[Jon U. Alonso, executive]

Thanks a lot, Fredrik, and good afternoon, everyone. Hope you are doing well. We would like to share with you now the main highlights of our financial performance this quarter.

From a total revenue point of view, Camurus achieved SEK 227 million in the quarter, delivering a growth of 64% versus same period last year with product sales of SEK 225 million, growing at 65% versus prior year and 11% versus prior quarter. Operating results for the quarter was positive and reached SEK 7 million, meaning a SEK 67 million improvement versus second quarter last year. And the trend, as explained by the chart, shows our commitment to profitability.

As Fredrik has mentioned, this quarter settles a historical milestone for Camurus as it was the first profitable quarter for the company, delivering a positive earnings per share of SEK 0.5, equivalent to a profit after tax of SEK 8 million. On a year-to-date basis, company revenue was SEK 447 million, growing 69% versus prior year, delivering a SEK 12 million positive operating result.

Our cash position at quarter end was SEK 428 million, which is a 1% growth versus same period prior year. As you may have seen in our cash flow statement published this morning, our cash flow from operations, including working capital change has been positive by SEK 10 million. And as of end of quarter, Camurus has no debt.

If we move now to next slide, we can see the main components of our operating result once revenue has already been covered. Gross margin reached SEK 202 million, improving 388 basis points as reported versus same period prior year and delivering an 88.5% year-to-date. Total OpEx reached SEK 196 million, a 10% increase versus same period prior year, driven by following 3 factors. Sales and marketing investment to support market penetration in our own territories and expansion of Buvidal into new markets. Secondly, corporate functions development. And thirdly, catch up in our operational R&D milestones from prior quarter this year.

As a result, our operating results became positive by SEK 7 million in the quarter and SEK 12 million year-to-date, mainly driven by sales growth and gross margin improvement. As we continue our investment in our pipeline to bring product candidates to market, it may take a couple of quarters to see our profitability is stabilizing.

At this point, Fredrik and I would like to communicate to you all an improvement in our operating result, '22 full year guidance and raise it by approximately SEK 35 million. From an initial guidance range of minus SEK 60 million to plus SEK 10 million to an improved range of minus SEK 20 million to plus SEK 40 million with no change in top line guidance.

Thanks a lot, everyone, for your attention. And now I would like to pass the word to Richard.

[Richard Jameson, executive]

Thank you, Jon, and hello, everyone. I will start with the continued good progress with Buvidal. In Q2, we achieved 12th consecutive double-digit quarter-on-quarter growth, reaching SEK 225 million, a growth of 65% over the same quarter last year. We've estimated we are close to now having 30,000 patients in treatment at the end of Q2. We achieved this through continuing to build our market leadership in the Nordics, for example, where we had strong growth across all the markets. In the U.K., we have positive market share development in Wales and Scotland. And importantly, as we see the impact of new government funding becoming available, we've seen strong acceleration in England, which has grown more than 100% in the first half of this year versus the second half of last year; 60% of the municipalities in England now have patient access to Buvidal.

In Australia, we're maintaining our leadership in the long-acting buprenorphine segment and improved our label for Buvidal with reimbursement of 160 milligram dose and direct initiation on to Buvidal, which is unique for the long-acting buprenorphine products. Furthermore we improved access in our future growth markets, including Spain and France and the MENA region. As a notable example, in Spain, over 90% of eligible patients live in a region that now has access to Buvidal. We're also expanding access in all treatment segments, including criminal justice settings across all of the markets.

So going forward, we will continue to focus on the commercial execution on our markets, to accelerate patient access and uptake. For markets where we have full access, we focus on facilitating patient uptake through medical education and informed choice, ensuring Buvidal is offered as a first-line treatment option. In countries where there is some restriction on access, we're addressing the barriers through communicating the compelling value proposition and addressing funding. And finally, we're planning launches in those markets where we are waiting the pricing and reimbursement approvals, having submitted dossiers that clearly demonstrate the value Buvidal brings to health economies, physicians and of course, patients. We remain on track to realize our goal of adding 100,000 patients on Buvidal by the end of 2026.

As we build our business, there's also a significant additional upside in the outcomes of ongoing regulatory and market expansion processes. In the U.S., the news from Braeburn is that the FDA has initiated inspections of Braeburn's third-party manufacturer. Depending on the outcome, Braeburn will resubmit the Brixadi NDA as soon as practicable, with a 2 or 6-month review period to a new PDUFA date. And with the history of the past, we see this as positive news for Buvidal.

In addition, we're progressing the market authorization applications in 7 additional countries, in MENA region with the expectations of approval decisions in Q3 and the coming quarters.

And for chronic pain, we've made variation applications in Europe and Australia. And according to the procedure, we're preparing responses to CHMP, request for supplementary information, and we anticipate a CHMP opinion in Q4 this year and a TGA approval decision in the first half of next year.

We also have had high visibility and a significant presence at scientific conferences with a number of presentations in Q2 at both international and national level. They have included many presentations on physician and patient experience with Buvidal and the positive impact this innovation is having on those suffering with opioid dependence. Our medical affairs team will continue this high level of activity with presence at the up-and-coming conferences and through building our robust clinical data, the real-world experience and evidence with Buvidal. Key congresses in H2 include ISAM, the International Society of Addiction, meeting in Malta in October and Lisbon Addictions, the European conference on addictive behaviors and dependencies in November.

So that completes the commercial update on a strong quarter, and I now hand back to Fredrik.

[Fredrik Tiberg, executive]

Thank you, Richard, and over to a brief R&D update in what has been a busy quarter.

Richard mentioned the ongoing regulatory processes and progress made to get Buvidal Brixadi approved in MENA and the U.S. and to expand the indication for Buvidal to include chronic pain. For CAM4072, weekly setmelanotide, our Rhythm -- our partner, Rhythm, continued recruitment in the ongoing Phase III switch study and are preparing for start of the second Phase III study in de novo patients with Bardet-Biedl syndrome in the second half of 2022.

So I will focus on the update about 2029 and CAM2043. CAM2029 is our long-acting octreotide investigational medicine currently under development for 3 rare disease indications, acromegaly, gastroenteropancreatic neuroendocrine tumors, GEP-NET, and polycystic liver disease, PLD. CAM2029 is designed for improved patient's convenience and potential for enhanced efficacy compared to current standard treatments with first-generation somatostatin analogues with annual sales of around $83 billion.

Based on the known properties and favorable target product profile of CAM2029, peak market potential across indications is estimated to between $1.1 billion and $1.6 billion in third-party market research. As you probably are aware, we have comprehensive clinical programs ongoing in these 3 indications to establish efficacy and safety as well as other clinical outcomes for CAM2029. This includes 2 Phase III studies in acromegaly, a randomized placebo-controlled trial and a long-term safety study, which both are in final stages of recruitment. In GEP-NET, a randomized active controlled study, SORENTO, is being performed with a primary objective to demonstrate superiority for progression-free survival, PFS, with CAM2029 versus standard of care.

Finally, in the second quarter, we started recruitment in a Phase IIb study, POSITANO, in a third indication, symptomatic polycystic liver disease, for which there is currently no approved treatment. In the POSITANO study, we are comparing 2 dosing regimens of CAM2029 versus placebo during a randomized treatment period of 12 months, followed by 3 months extension period and safety follow-up. The primary endpoint is liver volume and key secondary endpoint is our newly developed patient-reported outcomes tool, polycystic liver disease symptom score that we have developed together with our partners and aligned with the FDA prior to the start of the study. We are planning to include 69 patients in the study, randomized 1:1:1 and complete recruitment in the first half of next year.

I'm pleased with the progress made with CAM2029 during the quarter under challenging circumstances due to the prolonged pandemic and more recent issues caused by the ongoing war on Ukraine. Our team has done an excellent job in addressing these challenges and avoiding significant impacts on the study timelines and participating patients. We are now looking forward to a number of important milestones.

In acromegaly, we are expecting to complete recruitment during the fall and receive top line results from the Phase III efficacy study in H1 2023, followed by long-term safety results and regulatory submissions. In GEP-NET, we are targeting completion of recruitment of 302 patients in H1 2023. The study is event-driven, and the main efficacy part of the study will be completed after 194 progression events have occurred. In PLD, we are also expecting to complete the Phase IIb study in '24. In parallel of these developments, all CMC activities for the prefilled syringe and the new injection pen are being completed for planned regulatory submissions in late 2023 and '24.

So aside from the significant progress in our registration and Phase III programs, we also received top line data from an explorative Phase IIa study of weekly subcutaneous treprostinil in patients with Raynaud's phenomenon, secondary to systemic sclerosis. The study did not meet the primary specified endpoint of statistical significant effect on finger temperatures after cold challenges 6 hours post dose versus baseline. However, several secondary endpoints were met, including a positive effect on the primary outcome at 24 hours post dosing. And importantly, indications of robust improvements of the Raynaud's condition score, including at day 8 and day 15 post dosing. These effects were quite significant.

Pharmacokinetic and safety profiles were comparable to those reported earlier from our dose escalating Phase I study of CAM2043. So next steps include completing the study report and reviewing the detailed results and the development program with study investigators and external experts.

So before summarizing this presentation, I would like to take the opportunity to promote our upcoming Capital Markets and R&D Day, where we will be presenting more in-depth updates on Camurus, our business progress and key R&D programs, including presentations by leading clinical experts. This event will take place at the Royal Academy of Engineering Sciences in Stockholm on Tuesday, the 6th of September, and information can be found on our website. So you are most welcome.

With that, it is time to wrap up the call with key takeaways followed by Q&A.

So I think it's clear that Camurus had a strong second quarter and a first half of the year, where we, for the first time, reached profitability driven by successful commercial execution. We continued advancing our late-stage programs towards potential new market approvals and raised our guidance for full year 2022 results.

So with that short summary, thank you all for listening. And now over to Q&A. Operator, please take over the call.

[Operator]

[Operator Instructions] And the first question will be from Viktor Sundberg with Nordea.

[Viktor Sundberg, analyst]

Viktor Sundberg, Nordea. First of all, congrats on a great quarter. So my first question is on Europe and growth. So sequentially, it seems that you were down in the quarter with about minus 2%, which is the first sequential drop I've seen. You have compensated, of course, by strong growth in Australia, but any reason to worry here? Or could you elaborate a bit more in detail which markets that had a negative impact and contributed to this quarterly growth number?

[Fredrik Tiberg, executive]

I don't follow you there, Viktor. Nevertheless, we have had, in most European countries, we had very strong growth in the Nordics. We were over 20%. So I will have to refer here to Jon. Can you comment on that?

[Jon U. Alonso, executive]

Total product sales, Viktor, we are growing 11% quarter-on-quarter. And in Europe, we continue growing in most of our markets by very high double digits. So we don't -- we have not realized a 2% decline. It's quite of the opposite.

[Viktor Sundberg, analyst]

I was thinking of sequential growth from Q1 to Q2.

[Fredrik Tiberg, executive]

I think, Viktor, it may be that there are some shifts because, of course, we are reporting actual sales versus in market, but the in market growth in Europe has been consistent with previous quarters. There may be some fluctuations there, but I wouldn't take that as with any significance.

[Viktor Sundberg, analyst]

And a follow-up here. In Spain, I'm a bit curious on your initial feedback on the launch. My market research indicated this is a very heavy methadone market in terms of use. So very interested in hearing more about the success you've had in converting patients here initially.

[Fredrik Tiberg, executive]

So I think -- I mean, it's fair to say that we are early days in Spain from one aspect, but we have completed now all the regional work and got Buvidal introduced to and available in all markets. Spain does have a lot of methadone use, but for -- you could say it's mainly low dose. So it's a more easily transferable population. But I'll go over to Richard here. Can you comment on this, Richard?

[Richard Jameson, executive]

Yes. I mean, I think you said it, Fredrik. Really there is more than 10,000 patients on buprenorphine in Spain and obviously others on methadone, which is generally a low dose, as you said. And look, we're at the start here. We spent a long time overcoming the regional hurdles around funding. We've now solved that problem. And now it's all about commercial execution in terms of penetration in that market and getting patient access to Buvidal.

[Fredrik Tiberg, executive]

And maybe adding one comment there is that we are seeing, I mean, we are seeing very strong growth in Spain, but it is from a low base.

[Viktor Sundberg, analyst]

And a final one before I jump back into the queue. But just in France also, how much growth in that market comes from the [ prison ] system versus the [ CSAPA ] system, some of the budget constraints that were elaborated upon in Le Monde article not so long ago. I just -- I mean, I was interested in the details here for France as well.

[Fredrik Tiberg, executive]

Richard, do you want to take that?

[Richard Jameson, executive]

Yes. I mean it's a mix. I think probably CSAPAs, I don't know the exact number. But I think CSAPAs are probably a higher percentage of the overall. We're still making good progress in France. You're right, the Le Monde article was very clear that the unmet need and the demand for Buvidal, and we've just got to take each region now and address the funding in each of that region to move forward, and we've been successful in a number of regions to do that. So we now know how to do it. We're just going to roll that out. We've also expanded our team in France to help us do that as well.

[Operator]

And the next question will be from Suzanna Queckborner with Handelsbanken.

[Suzanna Queckbörner, analyst]

Hello, it's Suzanna Queckborner here, Handelsbanken. And congratulations on these quarter results. I have 3 questions. Perhaps I can take them one at a time. So starting off, with regards to the FDA inspection at Braeburn, a manufacturer in the U.S., would you imagine the FDA will need to re-inspect post the resubmission? Or do you think that once the 483 observation with the manufacturing sites cleared, a review could be finalized without a need for yet another inspection? In other words, what is this inspection about?

[Fredrik Tiberg, executive]

Yes. I think it's fair to say, and I'm relying on third-party advice here is that FDA usually do not repeat inspections unnecessarily. So if they have inspected a manufacturer and found them to be adequate in terms of their quality systems, et cetera, they will not re-inspect unnecessarily. So I think that's the basic guideline I can give you. I can't give you anything more specific here, unfortunately.

[Suzanna Queckbörner, analyst]

And then to my second question, which Viktor already mentioned earlier, and I thought I'd just reiterate. So if you look at the European sales, ex-Sweden, because in Sweden we see great growth. This is -- and then also account for a possible weaker Swedish krona. It really does seem like you have lower overall European sales in this quarter compared to Q1. You speak about progress in accessing some of the larger European markets and specifically Slide 11. But perhaps you can give us an understanding of these ex-Nordic European sales numbers?

[Fredrik Tiberg, executive]

Yes. I think we -- I mean, as we said, I mean, the Nordics are growing very well, double digits. And we are similarly seeing very strong growth in the U.K., Spain. We are seeing strong growth in France. So I think Germany is still -- is growing, but it's growing at a slower pace still, and we have talked about that and that we are implementing measures for the German market. So I think, overall, we see good growth in Europe continuously.

[Suzanna Queckbörner, analyst]

And then to my third question. On Buvidal for chronic pain and the label extension, I was aware that you had a review of this further indication at the end of June. And I was wondering what feedback you received from the EMA and what further information you need to provide in the Q4 review?

[Fredrik Tiberg, executive]

Yes. I mean, as you know, this is a procedural matter. So questions come in, in 2 rounds. We have had the second round of questions. They have been, yes, on various different topics around the studies and efficacy and so forth, and we are responding to them. As we are speaking, I think most of the responses have been prepared. So those are -- and of course, also the studies themselves, they are always part of this process. We have very similar processes for the opioid dependence indication. So we are following approximately that path that we had for the previous approval. But I can't go in on specific questions, no. Thank you.

[Operator]

And the next question will be from Peter Ostling from Pareto Securities.

[Peter Östling, analyst]

Thank you for taking my question, and I reiterate or the congrats on a great quarter. A couple of ones, if I may. First, I will come back to the geographical split of sales and focus instead on the Asia Oceania sales, which grew almost 100% year-over-year and 33% quarter-on-quarter. Is it only Australia that contributes to this growth? Or is it also increasingly the MENA region?

[Fredrik Tiberg, executive]

Jon?

[Jon U. Alonso, executive]

MENA is helping us to grow, to drive that growth. We have been able to open one market, Kuwait, and there has been material sales during the quarter in that aspect. So MENA is starting to contribute more and more to our growth.

[Peter Östling, analyst]

But it's still Australia that is the main driver of this 33% quarter-to-quarter.

[Jon U. Alonso, executive]

Correct. Australia is the main one, yes.

[Peter Östling, analyst]

And then on the Brixadi situation in the U.S., if I recall, the last time Braeburn resubmitted their application, they go to Class II review. What make you believe that you would get the Class 1 review this time, i.e., 3 months or 2 months review period?

[Fredrik Tiberg, executive]

We have not given advice on this. We have informed of the 2 different tracks that exist. Of course, this decision is made by the agency based on the information they have available at the time point of the submission and the review -- initial review of the submission. So I wouldn't say that what happened last time is indicative of what happens this time, but we are not giving any directions here. We're just showing the 2 alternatives.

[Peter Östling, analyst]

And then just briefly on the cost side. I guess that if you look at the selling expenses regarding all the preparations that you are making in new markets that you're entering that we will see maybe an acceleration in the cost for the selling expenses throughout the years. And also when it comes to R&D cost, do you still guide for around SEK 0.5 billion in 2022 that would imply about SEK 300 million in H2, if I do my calculations right? Is that fair?

[Fredrik Tiberg, executive]

So we can try to reply your questions, Peter. So starting by the R&D, more or less, we have invested as of now SEK 230 million. So to deliver SEK 0.5 billion, we need to invest SEK 270 million in the second half of the year and more or less this is our aspiration that we accelerate the execution of our pharmaceutical studies. But this is our aspiration and our commitment. So we will continue until that time. And yes, we will need to accelerate investment by SEK 270 million.

[Peter Östling, analyst]

And on the selling expense?

[Fredrik Tiberg, executive]

Yes. So selling expenses, as we have been disclosing during the presentation, we are investing more in our own territories to accelerate penetration and to be able to come to the market faster once we have access approval. Richard has commented that in France, we are investing more. We are investing in resources more. We have invested more in Spain. So yes, I see marketing and commercialization expenses will continue growing, I think in that range for the remaining part of the year. But it's fully aligned with our strategy.

[Peter Östling, analyst]

And then finally, just on the statistical analysis plan, the final one that you agreed with the FDA on the CAM2029. Was there any surprises compared to the one that you suggested, any major alterations after discussions with the FDA?

[Fredrik Tiberg, executive]

No. It was a confirmatory meeting really. So we had made ourselves some minor adjustments, but the FDA or the agency confirmed our approach.

[Operator]

[Operator Instructions] The next question is a follow-up question from Viktor Sundberg with Nordea.

[Viktor Sundberg, analyst]

So on guidance, yes, it looks like your OpEx only grew about 3% sequentially here. And I mean the 11% growth -- and with an 11% growth in product sales, it looks like your guidance range on EBIT is very conservative on midpoint. I mean you're already ahead of the midpoint half year-on-year EBIT. So what's the assumption for, let's say, the lower end of your guidance? Is there something I'm missing here in terms of R&D growth, which I get is flat sequentially, Q1 to Q2 here or an SG&A that could support a more negative scenario for full year numbers?

[Richard Jameson, executive]

So to answer your question, Viktor. Perhaps if you allow me, I would like to link this question to the conversation we just had with Peter a few minutes ago because Peter was asking how is going to our R&D investment going to board in the second part of the year, and I was comparing SEK 270 million versus SEK 270 million. So in the second half of the year, and as we are anticipating, on one hand, we are going to invest much more in R&D, Viktor. On the second hand, we will continue accelerating marketing investment. And on the third one, in terms of sales, still we need to grow around SEK 20 million to SEK 25 million per quarter to be able to achieve the top quartile of our revenue guidance, and we are talking about product sales. So that's why we are a bit prudent, and we are basically changing only the operating result. We -- on our hand, we don't think it is prudent. We think that there is a balance of risk and opportunities. And hopefully we will be able to deliver in our opportunities to succeed it. This is how we see it.

[Viktor Sundberg, analyst]

So on R&D, what's the increase mainly related to? And is that going to the numbers here early into the second half of next year or maybe at the end of next year in your opinion?

[Richard Jameson, executive]

Can you repeat the question, Viktor?

[Viktor Sundberg, analyst]

Yes. I just wondered on R&D, what the increase is mainly related to when you look at the second half of the year? Or if that comes in early in the year, on the next half year or late next half year?

[Richard Jameson, executive]

Our idea is to accelerate our execution in the second half of this year and is driven mainly by the patients enrollment and milestones in our -- mainly given that PLD and finally, completion of the acro studies that Fredrik has been mentioning before. So this is what we're assuming will drive our increase in R&D investment. Of course, if by any chance, we face contingencies of headwinds when we are investing it, there will be a postponement to next year, and this will impact our operating result guidance. But at the moment, we don't think it is neither prudent or ambition. We think it's in the midpoint of what we can deliver.

[Operator]

And the next question is also a follow-up, and it's from Peter Ostling with Pareto Securities.

[Peter Östling, analyst]

It's 2 questions. First on the CAM2043 project. Do you have any kind of speculation why you saw less effect at 6 hours and more effect at 24 hours? Is it the onset of the product or anything else that makes this difference? And also, I guess that Raynaud's phenomenon was kind of a gatekeeper for the entire project. But would you consider to go forward with PAH indication, even if you scrap the Raynaud's indication?

[Fredrik Tiberg, executive]

I think it's too early to give a response to that. As I said, we are reviewing the data. I mean, this is a small study and explorative. We are reviewing the data with our experts, and I don't think it is right to go out with any speculations. And some of those are quite experienced also in the PAH field. So it's a little bit early. But I mean, I've seen the response. And right now we have a conservative view and we will also have to wait the -- prioritize this program. So it depends a little bit on the relationship with our other priorities.

But I do -- I think it's too early to say anything on this. When it comes to the specific question about the 6-hour time point, this was predetermined. I think there might be -- it could be a lag phase in the response. It's quite speculative view. There is quite a lot of variability in the data as well, which plays out in the statistics. I think the most prominent effect was, of course, seen in the patient reported outcomes where there was a robust indication of efficacy. But when we do the overall assessment, we have to look at all the different components. And I think it's simply too early to give a view on that right now.

[Peter Östling, analyst]

And just lastly, on the Buvidal in the MENA regions. Why is it taking so long time for us to get formal approval? I guess, I mean, already in Q4 2020, you had more than 100 patients on early access. So what's happening in those countries, except for Lebanon that you received approval some quarter ago?

[Fredrik Tiberg, executive]

Yes, it's true. And I think this is not uncommon from a regulatory standpoint. The processes are -- first of all, of course, we submitted later in the MENA region than we did in other regions that the approval processes are, I would say, a little bit more extended and there is a lot of formalities and documentations, et cetera. But I think it's fair to say that all regulatory processes in MENA are following plan. So we're not seeing any deviations from the plan. But it's, of course, difficult to give any more specifics there.

[Peter Östling, analyst]

Do you -- have you received any kind of indication? I think you wrote that you have 7 applications that is being reviewed right now.

[Fredrik Tiberg, executive]

Yes. I mean -- so I mean -- I think the important thing is that Saudi, for instance, they did issue priority review status. So there is clearly an interest in these products in the region, and there is a clear unmet need. So we also had priority review in Lebanon, I believe. Wasn't that right, Richard?

[Richard Jameson, executive]

Yes. Yes, that's correct.

[Fredrik Tiberg, executive]

Do you have any further comment on that, Richard, by the way?

[Richard Jameson, executive]

No. It's just the time it takes. I mean we're doing everything we can to accelerate, of course, but these processes take time.

[Peter Östling, analyst]

Can you say how many you have on early access right now? If it was 100 in Q4, is it 150 now, Q4 2020, that was?

[Fredrik Tiberg, executive]

I think it's grown significantly since then.

[Peter Östling, analyst]

Are you getting fully paid for these early access patients?

[Fredrik Tiberg, executive]

Yes.

[Richard Jameson, executive]

Yes.

[Operator]

And the next question is from Mattias Häggblom with Handelsbanken.

[Mattias Häggblom, analyst]

Mattias Häggblom, Handelsbanken. So I had just one question for Fredrik probably. It's now roughly 7 months since you got or Braeburn, your partner, got the complete response letter for Brixadi in the U.S. Do you have at least some insight to the remediation process and the site inspections that FDA has planned or has performed? We have not. So how would you frame your optimism or pessimism of finally getting Brixadi approved? Is that changed compared to December? Has it deteriorated? Or has it improved? And if so, why?

[Fredrik Tiberg, executive]

I think what Richard said in the presentation is probably our view is that looking at the mirror and seeing the past, I think there is slight feeling of optimism. But I wouldn't dare to say anything more right now that I think we have to be prudent here. And I think that's the best I can provide in terms of comfort and confidence.

[Operator]

This concludes our question-and-answer session. I would like to turn the conference back over to Fredrik Tiberg for any closing remarks.

[Fredrik Tiberg, executive]

Yes. Thank you so much. I would just say, we've got the question here, which was also on the topic of, from Yuri about -- and the question is how -- which type of quality matter with manufacturers in the U.S. can hold up launching Brixadi for more than 1.5 years?

I would say that the agencies when it comes to quality matters and the manufacturing is very strict. And it's not controlled by the indication or the medical need, quality metrics are very important and have to be fulfilled, so to speak. So that is our answer to the question.

Other than that, I think I would also like to just comment on the previous questions about growth in Europe and in Oceania. There is a -- if there's anything, there is a disconnect between in-market growth and actually reported growth and it goes in the direction of Oceania for this term, and that may change, of course, in the next quarter. So that's the main explanation between the difference in views here.

And with that said, I want to thank you all again for your interest and listening into our call today. And I really wish everyone a nice and relaxing summer. And I look forward to seeing you all after the vacation. So thank you very much, and have a great summer.