Camurus Ab

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 cameras. Please note our forward-looking statements. And this is today's Agenda. With me on the call is John Garay, our chief financial officer, and on the phone from Cambridge, UK, is Richard Jameson, our chief commercial officer. Before going to highlights, here is a snapshot of cameras three years after the approval and launch of our first transformative medicine, Bovidal. We have Canfar. 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 needs, CNS, and rare disease areas with potential blockbuster status, and are showing strong revenue growth towards our 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 continued 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 applications for Buvidal in EU and Australia, to extend the indication to include chronic pain. Phase 3 programs of CAM-2029 in acromegaly and neuroendocrine tumors were further progressed, and we started a clinical phase 2b study of CAM-2029 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 John for a review of our financial performance in the period.

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, Camurius achieved 227 million SEC in the quarter, delivering a growth of 64% versus same period last year, with product sales of 225 million SEC growing at 65% versus prior year and 11% versus prior quarter. Operating results for the quarter was positive and reached 7 million SEC meaning a 67-million-sec improvement versus second quarter last year. And the trend, as displayed by the chart, shows our commitment to profitability. As Fredrik has mentioned, this quarter settles the historical milestone for Camulus as it was the first profitable quarter for the company delivering a positive earning per share of 0.5 kroner, equivalent to a profit after tax of 8 million SEK. On a year-to-day basis, company review was 447 million SEK, growing 69% versus prior year, delivering a 12 million SEK positive operating result. Our cash position at quarter end was 428 million SEK, 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 10 million SEK. And as a faint of quarter, Camoros has no debt. If we move now to the next slide, we can see the main components of our operating result once revenue has already been covered. Gross margin reached 202 million SEC, improving 388 basic points as reported versus same period prior year and delivering an 88.5% year-to-date. Total OPEX reached 196 million SEC, a 10% increase versus same period prior year driven by following three factors. Sales and marketing investment to support market penetration in our own territories and expansion of Boobies and into new markets. Secondly, corporate functions development. And firstly, catch up in our operational R&D milestones from prior quarter this year. As a result, our operating results became positive by 7 million SEC in the quarter and 12 million SEC 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 stabilizing. At this point, Frederic and I would like to communicate you all an improvement in our operating result 22 full year guidance and raise it by approximately 35 million seconds. from initial guidance range of minus 60 million sec to plus 10 million sec to an improved range of minus 20 million sec to plus 40 million sec 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.

Thank you, John. Hello everyone. I will start with the continued progress with Boverdale. In Q2, we achieved the 12 consecutive double digit quarter on quarter growth, reaching 225 million sec, 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 UK, we had 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 Boobadal. In Australia, we're maintaining our leadership in the long-acting buprenorphine segment and improved our label for Buvidal with reimbursement of 160mg dose and direct initiation onto 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 Buvedal 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're awaiting the pricing and reimbursement approvals, having submitted dossiers that clearly demonstrate the value Buvedal brings to health economies, physicians, and of course, patients. We remain on track to realize our goal of having 100,000 patients on Buvedal 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 US, 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 Brexadi NDA as soon as practicable, with a two- or six-month review period to a new PDUFA date. And with the history of the past, we see this as positive news for Buber now. In addition, we're progressing the market authorization applications in seven 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 requests 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've 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 activity with presence at the up-and-coming conferences and through building our robust clinical data, the real-world experience and evidence with Buberdar. Key congresses in H2 include ISAM, the International Society of Addiction, meeting in Malta in October, and Lisbon Addictions, the European Conference on Addictive Behaviours and Dependencies in November. So that completes the commercial update on a strong quarter, and I now hand back to Fredrik.

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 bubidol brixidi approved in MENA and the US, and to expand the indication for bubidol to include chronic pain. For CAM4072, weekly set melanotide, our partner Rhythm, continued recruitment in the ongoing phase three switch study and are preparing for start of a second phase three study in de novo patients with Bartlett-Beedle syndrome in the second half of 2022. So I will focus on the update about 2029 and CAM2043. CAMP2029 is our long-acting octreotide investigational medicine currently under development for three rare disease indications. Acromegaly, gastroenteropancreatic neuroendocrine tumors, GEPNET, and polycystic liver disease, PLD. CAMP2029 is designed for improved patient convenience and potential for enhanced efficacy compared to current standard treatments with first-generation somatostatin analogs. with annual sales of around 83 billion US dollars. Based on the known properties and favorable target product profile of CAMP 2029, peak market potential across indications is estimated to between 1.1 and 1.6 billion US dollars in third-party market research. As you probably are aware, We have comprehensive clinical programs ongoing in these three indications to establish efficacy and safety, as well as other clinical outcomes for CAM 2029. This includes two phase three studies in acromegaly, a randomized placebo-controlled trial, and a long-term safety study, which both are in final stages of recruitment. In GetNet, 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 2b 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 two dosing regimens of CAM2029 versus placebo during a randomized treatment period of 12 months, followed by three months extension period and safety follow-up. The primary endpoint is liver volume, And key secondary endpoint is our newly developed patient-recorded 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're planning to include 69 patients in the study, randomized one-to-one-to-one, 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're 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 three efficacy study in H1 2023, followed by long-term safety results and regulatory submissions. In GetNet, 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're also expecting to complete the Phase IIb study in 2024. In parallel of these developments, all CMC activities for the pre-filled syringe and the new injection pen are being completed for planned regulatory submissions in late 2023 and 2024. So aside from the significant progress in our registration and phase three programs, we also received top line data from an explorative phase two A study of weekly subcutaneous trypostenil 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 six 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 eight 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 one study of CHEM 2043. 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 cameras, 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're 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 Cambridge had a strong second quarter. and the 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.

Thank you so much. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. And the first question will be from Victor Sundberg with Noria. Please go ahead.

Yeah, hi. Victor Sundberg, Nordea. First of all, congrats on a great quarter and thanks for taking my questions. So my first question is on Europe and growth. So sequentially, it seems that you're 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?

Thanks. I don't follow you there, Lester, but 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 John. Can you comment on that?

Total product sales, Victor, 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 have not realized that 2% decline is quite of the opposite.

I was thinking of sequential growth, so from Q1 to Q2.

I think, Victor, it may be that there is 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.

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

So I think 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 Bibral introduced to and available in all markets. Spain does have a lot of methadone use, but 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?

Yes, I mean, I think you've said it, Frederick, really, you know, there is more than 10,000 patients on buprenorphine in Spain and obviously others on methadone, which is generally 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 patients access to buprenorphine.

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

Great. 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 casapa system? given some of the budget constraints that they were elaborated upon in a Le Monde article not so long ago. I'm just interested in the details here for France as well.

Richard, you want to take that? Yes, I mean, it's a mix. I think probably CASAPAs, I don't know the exact number, but I think CASAPAs 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 of 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've just got to roll that out. We've also expanded our team in France to help us do that as well, just for the point.

Okay, thanks very much. I'll jump back into the queue.

Thank you. And the next question. We'll be from Susanna Quickburner with Hannes Banken. Please go ahead.

Hello, Susanna Quickburner here, Hannes Banken. Thank you for taking my questions, and congratulations on these quarter results. I have three questions. Perhaps I can take them one at a time. So starting off, with regards to the FDA inspection at Brayburn, a manufacturer in the U.S., would you imagine the FDA will need to re-inspect posts 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?

Yeah, 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.

Thank you. And then to my second question, which Victor 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, 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.

Yeah, 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 UK. Spain we are seeing strong growth in France so I think Germany is still it's 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 Great, thank you

And then to my third question, on Buvadal 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.

Yes, I mean, as you know, this is a procedural matter, so questions come in in two rounds. We have had the second round of questions. They have been 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. And I can't go in on specific questions. No, thank you.

And the next question will be from Peter Osling from Pareto Securities. Please go ahead.

Yes, thank you for taking my question. And I reiterate or congrats on a great quarter. A couple of ones, if I may. First, I will come back to the geographical split of sales and performance. 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?

John, MENA is helping us 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.

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

Correct. Australia is the main one, yeah.

Okay, great. And then on the Brixodi situation in the US, I If I recall, the last time Braeburn resubmitted their application, they got the Class 2 review. What makes you believe that you would get the Class 1 review this time, i.e. three months or two months review period?

We have not given advice on this. We have... and informed of the two 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 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 two alternatives.

Okay, great. 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 and 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 costs, you still guide for around half a billion in 2022. That would imply about 300 million in H2 if I do my calculations right.

so we can we can try to reply your your questions uh peter uh so starting by the r&d more or less we have to invest this as of now 230 million so to deliver half a billion we need to invest 270 in the second half of the year and more or less this is our aspiration and we accelerate the execution of our pharmaceutical studies. But yes, this is our aspiration and our commitment. So we continue trending at that time, and yes, we will need to accelerate investment by 270.

And on the selling expenses.

Yeah, 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 to come to the market faster once we have access approval. Richard has commented that in France we are investing more. We are investing three resources more. We are also investing more in Spain. So, yes, I think 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.

Okay, great. And then finally, just on the statistical analysis plan, the final one that you agreed with the FDA on the come 2029. Was there any surprises compared to the one that you suggested? Any major alterations of the discussions with the FDA?

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

Okay, great. Thank you. I get back into the queue.

Thank you so much, Peter.

And once again, if you have a question, please press star then one. The next question is a follow-up question from Victor Senberg with Moria. Please go ahead.

Hi, thanks for taking my follow-on question. So on guidance, it looks like your OPEX only grew about 3% sequentially here. 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 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? Thanks.

So thanks for your question, Victor. 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 evolve in the second part of the year. And I was comparing 270 versus 230. 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, Victor. 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 20 to 25 million SEK 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. 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. This is how we see it.

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

Can you repeat the question, Victor?

Yeah, 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. Thanks.

Our idea is to accelerate our execution in the second half of this year and is driven mainly by the patient's enrollment and milestones. in our mainly GameNet, PLD and finally completion of the ACRO studies that I think has been mentioned 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.

Okay, thank you very much.

Thank you. And the next question is also a follow-up, and it's from Peter Ostling with Peretta Securities. Please go ahead.

Yes, thank you for taking my follow-up. It's two questions. First, on the CAM 2043 issue, project. Do you have any kind of speculation why you saw less effect at six 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 Reynolds Phenomena was kind of a gatekeeper for the entire project, but would you consider to go forward with the PAH indication even if you scrap the Reynolds indication?

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 pH 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 you know, weight, prioritize this program. So it depends a little bit on the relationship with our other priorities. But I think it's too early to say anything on this. When it comes to the specific question about the six-hour time point, you know, this was predetermined. I think there might be and 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.

Okay, fair enough. And just lastly on the Bovidal in the MENA regions. Why is it taking so long time 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 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 in other regions but the approach approval processes are i would say a little bit more extended and there is a lot of formalities and documentations etc But I think it's fair to say that all regulatory processes in MENA are following the plan. So we're not seeing any deviations from the plan. But it's of course difficult to give any more specifics there.

Have you received any kind of indication I think you wrote that you have seven applications that are being reviewed right now.

Yes. I think the important thing is that Saudi, for instance, they did issue priority review status, so there's 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. It wasn't that right, Richard?

Yes, yes, that's correct.

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

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.

Okay. 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.

I think it's grown significantly since then.

Okay. Are you getting fully paid for these early access patients?

Yes. Yes.

Yes. Okay. Okay. Thank you. Thank you. That's all from me.

And the next question is from Matthias Hagblom with Hannes Banken. Please go ahead.

Thank you so much, Matthias Hagblom, Hannes Banken. Just one question for Fredrik, probably. It's now roughly seven months since you got, or Braeburn, your partner, got the complete response letter for Brixar in the US. 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 Brexade approved? Is that changed compared to December? Has it deteriorated or has it improved? And if so, why?

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

Perfect. That's clear. That's all.

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

Yes, thank you so much. I would just like, we got the question here, which was also on the topic of, from Joran Giselius about, and the question is how, which type of quality matter with manufacturers in the U.S. can hold up launching Bricsadi for more than one and a half 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 matters 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. If there is 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 or so. So that's the main explanation between the difference in use here. But with that said, I want to thank you all again for your interest and listening in to 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.