Earnings Call: H2 2018

Mar 29, 2019

Ready to begin? Okay. Good morning and thank you for being here at our full year report presentation for the year 2018. Let me state one thing which we think is nice, should be taken as a good thing. Kosmos got now 3 approved products that comes from the same MMX technology. We started with Nialda, then we went further with Euceris. And now finally, Aimcolo, our new antibiotic, has been approved. And we are quite proud of this achievement. We've been trying to understand if there are actually companies that have 3 or more products approved with the very same technology, and we haven't been able to find a peer. Let's walk you through what happened in 2018, which has been a very busy year. In November, finally, the FDA approved our new antibiotic Aimcolo. That actually was a very smooth dialogue with the agency and a very smooth interaction. Everything worked well. The drug was approved exactly within the stated time line. And as I said, the process was very smooth. Everything went very well. Now Aimcolo enjoys marketing exclusivity until 2028 with its QIDP, which stands for Qualified Infectious Disease Product Designation and New Chemical Entity, MCE, designation. In the meantime, Doctor. Falk Pharma has received approval through the European decentralized procedure for Relafalk and now has got marketing authorization granted in Germany, United Kingdom, Spain, Denmark, Greece, Finland, Hungary, Norway, Portugal, Poland, Sweden and Bulgaria. They're launching in a few months in Germany and the other countries will follow at the beginning of 2020. Our Phase II proof of concept is progressing in IBS D. The trial is open and ongoing in Belgium, Italy, Spain and Germany. And in the meantime, we're setting the stage for further expansions in other indications. The franchise of Lealda is grown in Japan and is grown in the United sorry, in the European Union. But even more importantly, that of Cortiment, Euceris, is quickly growing all over the world. Now Cortiment, which is the brand name of Euceris under our licensee faring, is approved in 61 countries, has been launched in 38 and it's under registration in 2018. You know that in the meantime, generics were launched in the U. S. Both for Lialda and Nu. Series. We will walk you through afterwards on what's going to happen in respect of our expected revenues. ELEVUE gross sales in the United States were close to €11,000,000 and the net sales after the royalty to Olympus were EUR 7,500,000. We've sold 23 1,500 units in the course of 2018. We've signed an exclusive distribution agreement with Fujifilm to expand the franchise of Eleview beyond Europe and South Africa to Southeast Asia, Middle East, Africa, Australia and New Zealand. We've licensed Eleview, Methylene Blue, Aimco and Cobaltag for Canada to pharma science. We've cashed in a milestone and we'll earn nice royalties. Pharma Science has made regulatory submission for Metlin Blue MMX and Elavu and approval is expected in Q3 of 2019. It will be very nice if we could get around August the approval of Metaline Blue MMX in Canada. We've licensed Metaline Blue and Elevu for Japan and South Korea to EA Pharma. We received an upfront payment. EA Pharma is a very large player in the gastrointestinal field. We had a pre NDA meeting for Remimazolam with the FDA. Submission of the NDA was expected by the end of this quarter. Actually, I think it will be moved 1 week or 10 days from now. So it's expected to be within the first half of April because there's been a delay in providing us with certain information that was required within the NDA package. Our associate, Casiopeia, of which we continue owing 45%, has communicated a sequence of very good news, including the success of the Phase III clinical trial for the acne drug Winlevi, and you have probably seen the news that we recently released about also the successful study 27 for the use of Winlevi over 12 months. We communicated also the successful Phase II clinical trial interim analysis of BRISULA at 6 months for the treatment of androgenetic alopecia. And the full Phase 2 data for BRIZULA should be released in a matter of days. It is very important though that you consider the following. I'm opening a bracket here, but this is the right point and we should open a bracket. The Phase III of BRISULA will be on a 6 months treatment. And we have already published the results of the 6 months Phase II treatment. So you should assume that, that is going to be the reference point. It's not going to be the full year because the Phase III will be on a shorter time frame. So in order to try to figure out whether the Phase III of BRISOLA will be successful or not, you have to consider that we already have the data of the 6 months of the Phase II. So you have to take that in consideration. And because the data of the Phase II were extremely good, we have no reason to doubt that the Phase III of BRISOLA will follow along the lines of the Phase II data. As of the 27th March 2019, our stake in Casiopea is worth EUR 184,000,000 compared to $134,000,000 at 31 December 2017. In November, we placed €175,000,000 convertible bond due 2023. We've been raising net proceeds of EUR163 1,000,000. The annual coupon is EUR 2,500,000. Maturity is 5 years. And we believe that we have raised capital at very favorable conditions overall. I assume that there will be questions afterwards also about the convertible bond. One of the things that I may say in this respect is that probably everyone will remember that towards the end of last year, there were growing concerns about the state of the financial markets. There was wide expectation of some sort of crisis that fortunately didn't materialize right now. And so we were kind of thinking that if the conditions would have changed, it would have been more difficult for Cosmo to access the capital and we thought that the conditions were convenient. And therefore, when we had to decide whether to go for the bond on just hold, fearing that the market conditions may deteriorate, we thought that it was a good idea to raise the capital at that point in time. Important feature for us was the fact that we are entitled to reimburse the bond if we do elect to do so using up to 2,400,000 Cosmo shares, which is a feature that's normally reserved to much larger issues that has been object of very tough negotiations with banks that placed the bond. And this was just especially crafted for the company to reduce its overall risk. And we believe that therefore, we do have a very significant firepower to very attractive terms. Let's talk about the disappointments. Metylene Blue was not approved by the NDA, notwithstanding the special protocol agreement and notwithstanding the excellent trial results. We decided to step into the dispute resolution process, first, because we were hopeful that the FDA might have changed his idea, and this is exactly what the dispute resolution process is for, but not only for that reason. The essential reason why we entered into the dispute resolution process was because there was the absolute need for us to clarify the issues that were raised in the complete response letter so that we could identify a path forward in order to do eventually a second trial if the dispute resolution process wouldn't have been successful. The outcome is exactly as envisaged, although disappointingly. We haven't been able to obtain the approval of the drug, but we have been able to clarify the issues to an extent where we know now that what we need to do in order to present a second trial and try to execute it very quickly and smoothly. So I wouldn't want you to think that it has been a waste of time to go through the dispute resolution process. To the contrary, this has been essential in order to understand how to craft a second trial. However, disappointed we might be and we are extremely disappointed. We thought that everything was really clearly set in the special protocol agreement. It looks like the FDA can sort of do more or less what they like because they simply disapply the special protocol agreement and they said, well, you know what, it's true. We agreed that a single trial would have been sufficient, but now we've changed your mind our mind. We just think that you should do another one because we want to see more confirmation. Methylene blue will be used by millions of people. Colonoscopies are done by the millions. And therefore, we just think it's more appropriate if we do a second trial. And our simple answer to this is that whatever they have told us, they actually could have told us before because the real money that the company spent and the real time the company wasted was to negotiate a special protocol agreement, which has turned out to be basically useless. The company had spent back in 2014 close to 2 years to negotiate the protocol and spend money to do that. And we thought that we were on a very safe spot. Things turned out to be different. This is what happens sometimes in life. But it's important that you understand that in front of the CRL, the complete response letter, we couldn't have possibly said, okay, let's start another trial because there were so many things that needed to be clarified that we absolutely had to go through that process. So I'm glad that we did it. Now we think that we're in a condition where we can present a new protocol and try to start the new trial as quick as possible. In the meantime, in February 2019, we have filed the marketing authorization application within the European Medicine Agency. This is under review and actually approval is expected by the beginning of next year. Financial review, I would pass now the word to the CFO, Niall, and I'll go back with you after this is finished. Thank you. Thank you, Alex. So in 2018, we had revenues of CAD65,600,000. This compares to CAD67,200,000 last year. I'll give you some more detail in a moment in terms of the product revenues. Our operating costs increased by €5,400,000 up to 82,200,000 dollars There are two aspects to this. In our Ares Inc operating costs, they increased to €33,700,000 from 30.3 percent, but CHF18,200,000 of business personnel expenses and CHF15,500,000 are other costs, sales, marketing, promotion, market research and so on. Our R and D costs increased to $10,400,000 due to clinical trial costs, expenses, the P and L. Our operating loss for the period was $16,600,000 versus $9,600,000 last year. In terms of our net financial income, we had CAD4.6 million of income this year. This compares to net financial expenses of CAD16.9 million last year. The main reason for this is net FX gain in the current year of SEK 5,000,000 compared to an FX loss of SEK 18,400,000 in 2017. This is mainly related to the movement in the euro dollar rate over the period and our U. S. Dollar holdings. With a loss after tax of CAD18.1 million compared to a loss after tax of CAD22.5 million last year. So this is our income statement on Slide number 14. Some more detail now on the revenue. So UCERIS, there was a generic launch during 2018. So we saw Bosch also launched an authorized generic during the year. But the combined revenue of the authorized and branded products fell by 28% to $96,700,000 Our total income fell by 32% to 17.5%. Our royalty percentage dropped from 12% to 6% effective Q4. So this obviously is going to impact into 2019 when we see the full year impact of that generic in the market. Courtiment, on the other hand, net sales there grew by 12%. Our income was €3,900,000 versus €4,400,000 last year. Last year included a milestone of €1,000,000 that did not reoccur in 2018, but our manufacturing income and royalty income is up. Ialda, we had a reduction here of €4,500,000 This relates to the launch of a generic in the U. S. So you can see here our U. S. Drop in revenue was partially offset by increases substantial increases in Japan and European Union. EllaView, we had net income of €6,800,000 That's a big increase on FY 2017. In terms of license fees, upfront milestones in generic, we had €5,700,000 in upfront fees and milestones compared to $1,500,000 last year. And our generic and other was up 12.5%. In terms of operating expenses, we had our COGS is pretty much flat on year over year. As we mentioned earlier, the R and D is up as a result of increased clinical trial costs. SG and A has increased as a result of the U. S. Organization and the full year impact of the hires we made in 2017. So importantly, following the setback of Methion Blue, we've reviewed our U. S. Cost structure. We've taken steps in Q1 to reduce that cost base. We anticipate costing the €15,000,000 in 2019 versus 2018. The annualized impact of the action we've taken will be in the order of €20,000,000 to €25,000,000 Okay. So our loss before tax, €17,500,000 and loss after tax of €18,100,000 euros In terms of our balance sheet, it's shown here on Slide number 20. Here's the detail of non current assets and current assets from the previous slide. And in terms of the main assets, so we hold cash and investments in funds and bonds of €375,800,000 compared to 247.2 Obviously, the proceeds of the bond convertible bond issue are in here. Our investment in Cassiopeia, as Alex has mentioned, is carried out at $130,400,000 on our balance sheet. The market value is $184,500,000 as of the 25th March. So we've current and non current tax assets of $17,000,000 trade receivables and inventory $16,700,000 and other investments of 15.5 So we've got intangibles of 35,600,000 on our balance sheet. Of that, dollars 21,600,000 are capitalized development costs. You can see here on Slide 23 the analysis by project. We also have SEK10 1,000,000 capitalized for the Bemini Malin license and we're carrying a patent rights of SEK3.9 million. Dollars In terms of our cash position, as mentioned, we're holding $275,800,000 in cash and investments in funds and bonds. You'll see here that we've taken down substantially our U. S. Dollar holding and we've taken out that FX risk throughout the course of 2018. This is also in line with the us reducing the cost structure in the U. S. And less requirement for dollars going forward to fund that operation. On the liability side of the balance sheet, this year we've got the liability component of the convertible bond. That's 100 and $58,200,000 in total, including some other small borrowings. We have current and deferred tax liabilities of 7,900,000 dollars trade payables $8,800,000 of the liability to $5,900,000 giving total liabilities of $180,800,000 dollars So our equity position is $444,900,000 at 30thirty 1 December. In terms of our cash flow then for the period, we did net cash outflow from operating activities of $10,200,000 We had investments, capital expenditure of $1,900,000 investments in intangible assets, €7,800,000 net outflows in relation to investing activities of €64,900,000 and cash flow from investing activities then an outflow of 71 point 8,000,000. In terms of cash flows and financing activities, we had repurchasing treasury shares. So we spent a CHF 18,400,000 in 2018 on treasury shares. The net proceeds from the issue of the convertible bond were 163,500,000 and over the period we had a net increase in cash equivalents of $62,500,000 So I'll hand back to Alex for the 2019 outlook and big priorities. Thanks, Niall. So let's see how 2019 is going to look like. The near term's catalysts are the following. We're expecting the release of the full Phase II results of BRISULA. These are the results on the 12 months treatment. As I said, keep in mind that in July, we released the results of the 6 months treatment and that the Phase III will be modeled on a 6 months treatment as well. So the reference point for investor and analyst to make assumption on the success of the drug potential success of the drug in a Phase III needs to be modeled upon the result of the 6 months Phase 2 and not the full year Phase 2. Still, these are going to be very important. I'm very hopeful that they will be very nice data, but it's important that investors understand that the data that you have to look at in order to craft the Phase III trial are the 6 months results, which have been already published. This product is very important because you have to keep in mind that although Casiopeia is owned only 45% by Cosmo because of the existing agreement, the development work is actually done by Cosmo. Casiopeia has got a very small lean, clean organization exactly for the purpose of keeping the overheads as low as possible. So the work that's been done there is done by the Cosmo development team. So I think that investors should appreciate that when you look at the results of Levi and you look at the results of Briesville and you actually look at the results of the whole Casiopea portfolio, these actually happen thanks to the Cosmo clinical development team and R and D team. So we see these products as if they're ours, although we only have a 45% stake in the company. We're very proud and very happy of that. So it's nice that CXOP has been able to deliver so far also on the Winnebelly side and on the reasonable side and hopefully conclude what had to be delivered also with this Phase II full Phase II data. The remandralum NDA filing, as I said, is on the go. We will have to pay high on €7,500,000 as agreed in the license agreement upon filing. We're very much looking forward this filing to occur, as I said, in the very next days. We have released the news that we have called for an R and D day here in Zurich on the 8th May. There will be significant announcements that we intend to do. They will clearly be anticipated by press releases as soon as the events materializes, but we will be in a condition by the 8th May to tell you a lot about what's going on and a lot about our future progress. And I'm just sorry that for compliance reasons, I cannot really walk you through right now about what is going to happen, but it will be pretty soon, 8th May. Another important step, as I said, for the reason that Casiopea, it continues to be essential part of Cosmo. We are expecting the NDA filing soon. Soon means, I think, the beginning of June because the filing is subject to a pre NDA meeting, which is now scheduled for the 6th May, if I'm correct. And normally, the NDA filing takes place 30 days after the pre NDA meeting. So you should expect a Win Levy NDA filing by the beginning of June. This is what we have scheduled. And of course, we're expecting by year end to be able to tell you about the AIMcolo IBS D Phase II results, which is going to be another significant catalyst. But we intend to talk a lot more about Aimcolor in the context of our R and D days. So that's going to be the venue when where you will have more substantial information on what exactly is going on there. We see Cosmo as a sum of part. So from our standpoint, this is basically a message of confidence. We think that Cosmos should be seen as a series of assets that can be independently managed if necessary. And I think that if you go just through the list of the assets, this continues to be a very compelling list. We have cash bond investments for more than €375,000,000 Our investment in Casi Pia is worth €184,000,000 dollars We have the Lialda Medlovan, Euceris Courtamin franchise. We have Encolo, which is going to be a very, very significant product. Reminoxolam on the go. Elanue is being sold in the United States. The methylene blue franchise continue. It's just, again, disappointing that we will have to do a second trial. But this is what we need to do to keep the value of the asset, which we believe is going to be a very significant asset. Nonetheless, we continue having our contract bag manufacturing business. There's an undisclosed pipeline on which we will be telling you much, much more at the R and D day and we have the investment in the other companies. So these are our 2019 estimates. We expect that we will be able to continue to reducing our operating loss. Our program is and our plan is to be back to profitability in 2020. The reason why we're not back profitability in 2019 is because Metaline Blue has not been approved, unfortunately. I just want to point out 2 items, which I think are worth mentioning. When you see the operating loss of 2018, the actual, and you see a loss of CHF 17,000,000 there, I just would like you to know that because of the IFRS, this loss also contains, for accounting reason, a cost of €9,000,000, dollars which is an ease of expense that actually will not materialize, but it's just something that needs to be taken into account. For the very same reason, the projected guidance that's given an operating loss of around €12,000,000 for 2019 contains a net of share stock option expense of €9,000,000 sorry, no, of €7,000,000 So if you look at the real operating loss, this ease of expense actually is not a monetary disbursement. It's just not something that you need to account for, again, for accounting reasons. It's important that this is taken in consideration when looking at what's going to be our operating loss. And clearly, this 2019 expected operating loss doesn't account for, again, the expected loss in Casa offset by the increase and hopefully significant increase in the share price. Casiopea doesn't have any revenue, so by the continued spending money. Therefore, we should expect that there's going to be another loss Casiopea in 2019 as Casiopea has already announced. And simply as we usually do, we just make clear that the share of results of Casiopea are not included into this guidance. Our key priorities for 2019 are the launch of Aimcolo to file reminazolam NDA in the U. S. To progress our product pipeline on which, as I said, we will tell more at our R and D day. The restructuring of our U. S. Organization, NIO has anticipated that we are restructuring Ares to the bone. We will achieve the significant cost saving. We're completely rethinking the mission of ARIUS, and this is an ongoing process. And then we expect that we will be able to reach an agreement with the FDA for the new confirmatory Phase III trial for methionine blue and possibly start the trial. Right now, we are in the process of drafting the new protocol and determining the sample size with our biostatisticians. So this is something that we plan to do within this year. Our final slide here, try to recap the way we think. Company is financially solid and has got plenty of opportunities, especially if you compare the current market cap of the company with the list of parts that actually compose the Cosmos business. So we look at the future with optimism, absolutely. And we've been optimistic and we continue to be optimistic. This is why we've been purchasing own shares in these last months. Now we currently approximately own 2% of the issued shares. These are purchases that have been done in the open market within the limits that are set to us for our daily trading, which is 20% of the daily volumes. And we intend to continue to do so because we think that the share price is really attractive. So we hope that we will be able to see you all at our R and D Day on the 8th March, and we'll be happy to answer to any question you may have. Thank you so much. Hi. I have first some questions on Ares and then on Enkelo. So what are the plans with Ares going forward because there are no real synergies between the commercialization of Alu and AMCOLO? So do you consider to out license commercialization of Enkolo or still do it by yourself or sell it? And then just on ENGELO, first, when do you consider to publish the scientific data? And then do you consider to conduct the Phase III trial by yourself or may of IDD by yourself or maybe with a partner? Okay. Thank you. Well, this question touches several issues in the meantime. The plan that we had for Ares was to go public upon the launch of Metylene Blue. This has not occurred. And therefore, we're perfectly aware of the fact that without Metaline Blue for quite some time, Ares doesn't fulfill anymore the original plans for which it was crafted. If methylene blue would have been approved, then we would have been able to leverage substantially on the build up that we had made in the previous months. Unfortunately, as I said, the non approval of methylene blue was unexpected. And therefore, we immediately took measures while we were going through the dispute resolution process. And these are already reflected in the expected savings that we will generate in this year, which clearly assume that the organization will be completely restructured. We're not thinking any more of a listing of areas clearly because we don't think that having AIMCO and Remedelan together without Metaline Blue make any more sense in the perspective of an independent listing. So we have scrapped that plan. We're restructuring the business. And going forward, we expect actually to launch Aimco on our own, but in such a fashion that we will be able, I think, to achieve substantial savings. And we will tell you more about this at the R and D day. I just don't want to be premature on this because we're preparing a plan that I would like to show and explain to investors in fledged mode. But yes, the idea is that Aimco, we're pursuing this by ourselves, absolutely. But that areas will be given a totally different scope, and it will be mainly a company that will provide services in the U. S. To the overall organization, but not anymore being a company that has the intention of going standalone. I don't know if this answers partially because there were many questions. You were also asking about scientific data publication. You were referring to the info, I guess, or which data? Yes. That's ongoing. Publications are being assembled and we're expecting publication to go out soon. The Phase III trial in IBD? Well, on IBD, we believe that we have all the knowledge that's needed to do it by ourselves. So there's actually no specific plan to partner with someone in the U. S, not at this stage. Okay. Thanks. Not at this stage because I may say that the creation of value there within the IBS and the other indications that we have in mind is actually ongoing. So even if partnering maybe could be an option, it's going to be, I think, an option when we have a more clear data there that are deemed to significantly increase the value of the asset. Mr. Borracha, thank you for your comment. I heard and I saw the word opportunistic quite often. I've been a shareholder with your company over the many, many years. And of course, I'm quite disappointed with the outcome of FDA. What I'm missing is, in a way, a critical dispute of the management of Cosmo with the outcome of FDM. When I look back over the last year, many milestones forecasts were not kept. I ask you whether you depend on competent consultants, which assist you in filing the process with FDA and if you really have learned the lesson. Because I think when I look especially at the outcome of 2019 2020 and you look with optimism to the future, those issues are very critical parts. Excuse me, are very critical. I'm not sure I understand exactly what is the question. I can tell you that the company has been using very competent consultants within the FDA process. And we thought we had everything we needed when we entered into the special protocol agreement. So maybe we frankly speaking, maybe we could have continued to pursue the legal vote. But as a lawyer myself, I think that I should be aware that litigation doesn't necessarily bring the results that you wish. And litigation may be very expensive and may leave you with nothing. So I have been told in my previous experience that a bad settlement is always better than a good case because you don't know how the good case is going to end up. And I don't think that it would have been a good idea for us to go and litigate against the FDA, maybe in court by saying that they were not respecting the special protocol agreement. This is the fact. This is the fact. But I think that we have to be practical and pragmatic. And if there's anything that the Swiss environment has taught me over the years is to try to be as pragmatic as possible and even more pragmatic than I would normally want to be. Here, the fact is that we thought we had gathered the information that we needed in the dispute resolution process. And now at this point, it becomes to us much faster to start a new trial and do it because we think we know what was needed rather than continue the litigation. When I look at things in retrospective, I think that every one of us make mistakes. And of course, we do mistakes as well. So if I have to look retrospectively, what we have done that we shouldn't have done, maybe we shouldn't have done we shouldn't have built Ares the way we did, being overly confident on the FDA approval. This is clearly something that we did. But it is also true that if methylene blue would have been approved, then we would have seen it booming because everything was ready there. You know the U. S. People have a tendency to build the army before the war, right? And maybe they use the army, maybe they don't use it, but if the war comes, the army is already there. And this is exactly what the area's case was. Everything was being set in order to be able to launch Radically Blue as effectively as possible as soon as it would have been approved. And this is why the non approval was worse than a cold shower. It was completely unexpected. Now, yes, I can blame consultants that were there even before I joined the company and they said, yes, this is good. This is going to you're going to be very protected. Consultants should have told us, hey, actually, it's very risky to go with a special protocol agreement because the FDA may just disapply it. So just do 2 trials. And frankly speaking, this is the whole irony in this situation because if we would have done 2 trials, it would have taken us basically the same time, we would have basically spent the same money and we would have basically employed the same time. So why didn't we do that? Well, that's because the FDA told us that a single trial was sufficient. Is very ironic. So if there's anything that we need to learn from this lesson is that we shouldn't trust the FDA. We shouldn't trust too much the advisers, and we shouldn't have gone for a single trial. I agree with you. So well, I'm happy to take all the part of the blame that you want me to take for this. But the reality is that you said you're a long term shareholder. Well, I am as well. I am as well. So it's important for you to know that the disappointment is completely shared. I share exactly the same disappointment. I can tell you that I believe that the company has really done its best because it's a company that continues to be run by a small number of people with small management team. We try to keep overheads under control as much as possible. And we've been actually, I believe, very prudent. We thought we had a very good plan there, the single trial. The results of the single trial are solid. The minimum p value that was required was 0 point 5. We reached 0.01. The FDA has said in writing, I can assure you, that the trial that we did is impeccable. They don't have anything to say. The trial is perfect. No deviation from the protocol, all endpoints met. They simply said, you know what, I thought about it. I just feel I feel more confident if you do a second trial. You said, but you agreed on 1. Yes, still, I think you should do 2. And this is yes, you are totally right. It's not fair, but the alternative that we had was to sue the FDA in court. I don't think that this was a viable alternative. So if you want to blame me for this decision, yes, this is my decision, not to sue the FDA, not to sue the FDA in court, because I think that we would have no chances there. I think that if I would have sued the FDA in court, the things would have turned really nasty. They have not raised any question on safety and any question on manufacturing, which are the 2 issues that can destroy a drug. Because if you have an issue on safety or if you have an issue on manufacturing, that can just kill the drug. And I can bet that if I would have sued the FDA in court, they would have immediately raised issues on safety. I can bet. They would have done whatever they could to discredit the company just to show that they're the big guys that always do better. And this all would have happened in front of the U. S. Judge. Sorry. If I want if you want me to blame for something, it's exactly for this decision, which has been taken just a couple of weeks ago, not to pursue anymore the dispute resolution route. Swiss pragmatism, hey, these are the information that we needed to have. Let's go for a second trial. Yes, we've lost a lot of time. We've lost a lot of money, but we still have a product that's viable. We still have a product that the very same FDA says is going to be taken by millions of people. Let's be pragmatic. Let's do the trial. But what is even more important for me is that investors and shareholders and loyal and faithful shareholders should not think that we've been wasting time here. When we received the CRL, the complete response letter, the issues that were raised didn't make any sense at all. So if we would have needed to take those into account, we wouldn't have known how to do a second trial. It was just, hey, we need to throw the drug into the dustbin because the comments that are doing there is just not making a second trial viable. Now the situation is completely different. We haven't spent a lot. We've hired a very good regulatory attorney firm in Washington. I think that they have been very, very helpful in helping us go through a smooth process. The quality of the interaction with the FDA has significantly increased during the dispute resolution process. And now we think we know how to proceed with the second trial. And you see, it's not even that one can say that the FDA, for whatever reason, is hungry with COSMO because you have seen we got an antibiotic approved, which actually, I think, has even got that higher potential in terms of sales than the methanol group. That was a seamless process. No issues. They've always been very nice to us, very good interaction. So you see, we don't have a problem with the FDA if we can get an antibiotic approved. And I urge you all to do something if you haven't done it, which I think is very telling. Because what I think the market doesn't know, or maybe it does is that immediately upon the approval of Aimco, the very same FDA issued a press release. Now I don't know how many of you have seen the press release, but the FDA has issued a press release. So if you go on Google and you type AimColo FDA, first thing that you will see is the press release that the FDA issued. And the press release well, actually, this doesn't happen very frequently, I can tell you. It doesn't happen very frequently. Very seldom at the FDA issues press releases and the press release even contains the statement on the importance of Aimco. And the statement is done by the Director of the Office for Antimicrobial Drugs. Now you go there, you look and you read the FDA press release about the potential of Aimco about the size of the market and you start making your own thinking there. It's very simple. Google Aimco FDA. So again, we didn't have a problem with the FDA. It has just been a very unfortunate situation with the Medical Imaging division. And I may say that this situation was also, I believe, triggered by the fact that this division normally has to do with diagnostic drugs and methylene blue is not a diagnostic drug. Methylene blue is not a drug that yields a disease and it's not a diagnostic drug because it doesn't actually tell you whether something is something or something else, which is a diagnostic. It simply helps you to see better. It's just a contrast agent, which is deployed through a different route and in a different manner. And I think that probably they had some issues in completely understanding also the mechanism of action of the drug. I believe, as I said, that these issues have been successfully discussed in the dispute resolution process. And so I'm looking with, as I said, with optimism to the new interaction. But I would like to make clear that at least for me, this is the optimism of reason, it's not the optimism per se. Right. The positive evaluation out. Thank you for those answers. Just on that front, I believe, looking forward, could you give us a little bit of the time lines of the second trial, what you think, when will it start, duration? And maybe also a little bit on the trial itself, will it be different than the first one? What are the difference that you expect? And of course, there's probably something you also address on May 8. Sure. And you need to take what I'm going to tell you with some degree of precaution because you know that when you try to figure out timings here, the level of imprecision is extraordinarily high. But I would be more than happy if we could have an agreement with the FDA by year end on the new trial and, therefore, do the trial next year. And And then, of course, you will need to start again the process. But you would then know that if the FDA agrees by year end on the new protocol, we can execute it successfully in the course of the following years, then there shouldn't be and if the trial is successful, there shouldn't be much hopefully, hopefully much questions left whether the drug will be approved or not. So I think that this is a time line that we have in mind and we will do our best to try to pursue it. In terms of what the trial will aim at, I can give you the following information. I think now it's absolutely clear with the FDA because there's been extensive exchange of written materials and letters. It is well understood that what methylene blue does is finding lesions. MetELINBLUE is not an intelligent drug that is taken only by adenomas and not by the rest. It's simply a contrast agent. So MedlineBlue finds lesions and because you find more lesions, thanks to MedlineBlue, you end up finding more adenoma. So this is the sequence. And what is now absolutely clear and also confirmed by more than excellent trial data is that MedlineBlue MMX is incredibly effective in finding more non polypositions, which are the flat lesion. When a lesion is protruding like this polyposit lesion with the shape of a polyp, everybody can see it. You don't need to be an expert endoscopist. You don't need even to be an endoscopist to recognize a polypoid lesion. The issue that you have is the flat lesion. And Medline Blue MMX is statistically highly, highly significant in finding more non polypositions, which are the lesions that you normally miss, which are the lesions that because you have missed, turned into cancers. So this has been now, I believe, very well understood. And so we're foreseeing a trial that will now concentrate on the detection of non polyposite lesion, where we have shown superiority in every possible context. And actually, this is exactly also what chromendoscopy does, which is the precursor of our drug. It finds more non polyposite lesions. So we believe that this is where we will concentrate our attention coherently with the discussion that's been ongoing with the FDA so far. So when in the press release, we mentioned the different endpoints, it's because not other normal detection rate. We think that we can concentrate on the non polypore lesion detection rate, which is the one that also gives immediately a very clear clinical benefit. If I may, 2 more questions because there's a lot of questions here in the room. On UCERIS, there's also litigation going there from Valient where they are appealing the decision for the generics. When do you expect the appeal decision? And also, do you have rights? Are you entitled to triple damages on that one? And then my final question is your war chest more or less, do you see opportunities there to buy other products to enhance also your R and D pipeline? In respect of the first question, I don't have maybe I don't have any specific news. The litigation is ongoing and I don't think Valeant I prefer to continue calling them Valeant although they've changed the name in Bausch. I don't think that they have been a good partner to us. I don't think that the drug has been promoted properly first. But as you have seen, we had an arbitration panel that had a different opinion on that, although the results are in front of everyone. Now they're managing the litigation, I hope that they'll do their best to preserve the franchise. In respect to the acquisition of the new products, I think it's important that we spend together some time at the R and D day, but we will tell you what we have been doing. And then I guess you'll be able to get an answer to that question according to and depending on what we will be telling you on the R and D day. I have a question on the bond. I'm not agreeing with you that it's a cheap financing. It was a very expensive financing. The shareholder lost $500,000,000 for you to raise $160,000,000 in cash. This is very expensive. So who made you advise that this has to be a convertible bond? Why didn't you access the market with a straight bond? Why didn't you sell straight shares? I think the market impact would have been massively less than this. Who advised you on this bond? Is it very complicated structure? I can tell you who advised us. Actually, it was a consortium of 3 banks. It was Credit Suisse, Jefferies and Bergberg. And that was, we thought, very originally crafted. The company was looking for protection in the worst possible downside situation, meaning black swan situation. This is why the feature on which we had been working extensively was to make sure that we could have a possibility of redeeming the bond with the issuance of shares. And we thought so turning the bond into what's called a quasi mandatory convertible. I'm not sure how much of the downturn in the share price, if you're referring to that, to the loss of value, is actually has been generated by the bond. No, no. No, I said that because I'm a shareholder myself, I know this pretty well and I know the impact of this on my portfolio. Trust me, I'm just trying to figure out whether we can for sure say that the negative impact that we have had on the share price has been generated just by the convertible bond or by a series of Yes, that's true. We are aware that actually the short selling was, I think, 500 and 80,000 or 530,000 shares and not in excess of that. This is the information that we have from Credit Suisse and I assume that the information is reliable. So that is just a limited amount. And I can tell you that as you have seen, we have repurchased more than 2% of the share capital of the company, which amounts to a little more than 3,000 300,000 shares, which means that out of those shares that have been sold by the short sellers, more than 300,000 have been repurchased by us. And I what I can't understand and what I don't know is if we have a sort of rolling short selling. Credit Suisse says that this is not happening, that the people that want to do the short now are just keeping their position and I don't know whether it's correct or not. I can tell you that I've met with several investors in London just to give you a different perspective. And very recently, and they told me that they have been selling Cosmo shares because they this was prior to the release that we will do the second trial actually. And they said, well, what we don't like is uncertainty. So we will be a purchaser again once this Madeleine Blue issue is resolved. But so far in this month, because of the uncertainty, we have been selling shares. So I don't know if the sale has been generated just by the bond or simply by shareholders that were willing to sell. I frankly do not know. So somebody has to do the lending. And I learned it was the main shareholder who did the lending. This is correct because this was a feature that was expressly requested by the banks and this was a decision of the main shareholder. And at the very end of the negotiation process, there was the alternative whether to launch the bond with the share lending facility or not to launch the bond at all. And so the main shareholders took the decision that he was providing the lending in order to make the issuance of the bond possible. I guess, again, I'm sorry that I find myself in this kind of a difficult situation because if we would be on the 8th May, it will be pretty clear why we have done that. And I'm sorry that I have to keep you in this lull for a little more. I am sure that it will sound reasonable to you once you will have the full pay share. Okay. Maybe you could elaborate a little bit more about what kind of black swan you really envisaged. Excuse me, what kind of? Black swan you envisaged. I mean, your company is cash flow positive if you're closing down areas. So you could have closed areas and you're immediately cash flow positive. So there's absolutely no need to for financing. You still had EUR 150,000,000 to EUR 200,000,000 cash. So I don't know. I haven't seen any company in November, December preparing for a Black Swan and issuing billions of convertible bonds. So it absolutely makes no sense to finance before you announce a deal, a deal, a possible deal. To me, I haven't seen that in 20 years. I wonder who advised you. No, we said who advised us actually for the bond. But just to be clear, because Cosmo is a small company and we've got a small management team, all decisions are taken unanimously. So if the issue is who decided to issue the bond, the answer is we all did because we all thought it was a good idea. Again, I'm sorry that I will have to ask you just to wait a couple of weeks more and then put everything into a context. I think I hope that you will agree that at least raising money made sense. In respect of shutting down ARIES, you see we decided that we would have pursued and successful. And we were even more hopeful that it would have been successful. And we were even more hopeful that it would have been successful because we were relying on a special protocol agreement. Therefore, you see to close Ares immediately in the aftermath of the complete response letter where we were still thinking that we would have been able to sort out the issues to the dispute resolution process would have been, I guess, not advisable. Because if we would have been successful, then it would have been back on track just with the delay of a few months. And because it has costed us so dearly to build up such an organization, I think that it would have been premature to wipe it out immediately in the aftermath of the complete response letter. We had to clarify a lot of issues before looking at whether that was really the case because what we did in areas was investment. So it's not the complete response letter that allows the idea that you have to write off all the investment all of a sudden. There's a lot of shareholders' money there and want to make sure that we can preserve what has been done in proper ways and strike out what is not necessary anymore. Alex, they should have warned you. I mean, credit freeze, should have warned you. Since you're not an they have the hedge funds only have one goal to immediately short the shares they take out of the lending because to cover their position. I mean, they should have warned you and tell you, there is 1,000,000 shares flowing into the market within 3 days. And you maybe have should have called some investors to be ready to take up some shares. Now since you are waiting for the investor state to send to give us some goodies, it would be a strong signal to the market if you would come up and say, hey, we buy back up to 10% of the shares. And then the short seller would come out of the bush and would run after the stock. And you need one day the shares to cover the convertible in a couple of years. And if you have the opinion that today the price is low, then it's a good opportunity to present just a buyback program. I mean, the market will be happy to see that you bought 2% discreetly in the market. But if you can't give a strong signal that you think the price is right at the moment, buy up to 10% and you will be fine and everybody will be happy. I think this is a good suggestion and we will certainly think about it. What I can just to answer to the question, yes, we were told that, that would have happened, but we were also told, and again, I think this follows up to discussions that we were having just a few minutes ago that this would have been a temporary effect, which would have lasted only no more than 10 days. And I can tell you that this was exactly what all the banks said. And we trusted that this was the case. So this is why I was asking myself and we were asking sales whether actually the consistent drop wasn't generated just by sellers for other reason other than purely short sellers because of the bond. And I don't have an answer and I don't have an answer to that. The reason why we've been doing this purchase discretely, I will tell you, well, 1st of all, because you know that as market maker, we're not allowed to make purchases on more than 20% of the daily volumes. No, no, no. No, you're sure. No, no, no. I'm going to answer to this unless we announce it, which we haven't done. So as market makers, we can't buy more than 20%. And actually, even though we can potentially buy 20%, that doesn't mean that we're actually able to enter into the transaction or catch the opportunities. A lot of trades are done without us having the opportunity to intercept the purchase. In respect of the buyback, you are right. But frankly speaking, we didn't issue the bond for speculative reason. We issued the bond because of the program that we have in mind that we want to looked, upon all the information that I've gathered tremendously opportunistic, if not really purely speculative, if profiting from the slide of the share, I would have immediately communicated share buyback because a lot of people would have then thought, because I know that this has happened pretty frequently on the market, that you have companies that do issue convertible bond, they do allow the share lending and the share price drops and then they use the proceeds of the bond to buy back shares. And this is not Cosmo. Cosmo is an industrial company. So I think it would have looked pretty strange if you would have done that. Everybody would have thought, hey, these guys are Cosmo. What is this? Are they becoming financial speculators or what? This has never been our intention. So I hope you understand what I'm saying. Now in this context, in March, that may be a different story. We will give it certainly a lot of thinking. But I hope you understand why I don't think that, that would have been a good idea in that context. We would have looked as sharks, and I think that would have been terrible. But if you announce that you are intending to buy back within 2 years 10% of the shares doesn't mean you have to buy them back. And if you have a better idea, every shareholder is more than happy if you invest the money in such a company or in such a project. You don't have to buy back 10%, but you can announce it. And you'll see that's a nice reaction to the short sales. This is a very fair point, and I thank you very much for raising. And what I can tell you for sure is that in the future, we definitely need to have more advice from Swiss investors than banks. Put it that way, if there is a lesson that we have learned the hard way is that we will get more advice from Swiss investors than investment banks. And that's a Swiss pragmatism, yes. Of course, you're right. After issuing the bond, Cosmos said that the proceeds might be used to financing some projects in U. S. Also that Ares can have another project, another product to sell. Is it fair say that you're closing in on a deal that you might announce on the Research Day? Or what can you give an update on this? Are you still looking for an in licensing or takeover? Well, clearly, we're working on something. But of course, I need to be very careful here not to look like that I'm trying to manipulate the expectations or whatever. The money was raised with a very precise purpose. We didn't want to touch our cash because that was already available. We wanted to have more to do what we were intending to do. And I'll tell you more on the 8th May. But we're clearly as I think those are kind of delicate statements. So in the statements about calling the R and D Day, I wanted to point out that we've been working relentlessly and silently to get certain things done. And this is why we want to put them into the right context. And I hope that when we will be illustrating the new strategy, a lot of things will become clear. I think Cosmo has never been doing, to my knowledge, anything reckless and certainly will not begin now. Well, a little more than that. This is not going to be just ideas. I think you will see and I hope that you will like it. And what I can tell you is that the whole team has really been working like crazy to get it done. So I'm really thankful because we have a lot of fantastic people that really put all their heart and their efforts into this. And at least you know that as a shareholder myself, I share exactly the same disappointment and I'm working to make it change. And any suggestion is frankly welcome. So I really appreciate what Bernard has been saying. We will really give it very careful thoughts. Absolutely. Just another clarification on the time line of the refining of Enkelo and launch. Is it if I understood you right, you're expecting to launch 'twenty two now or maybe end 'twenty one, 'twenty two in the U. S? In growth? No, the MMX sorry, the metal in blue. Oh, the metal in blue. Yes. Well, yes, assuming that everything is successful, as I said, end of this year, the agreement on the new protocol next year to execute the study, that will also depend very much on the sample size. Because clearly, you understand if we can keep it to a small size, that's going to be much faster, not just cheaper, but faster actually. Not an issue of money for us, it's an issue of time. So ideally, by the end of 2020, we should have the data on the release from the second trial. And then you have 1 year regulatory submission. But it's more important for investors to know that if there's an agreement with the FDA on the second trial and that second trial is successful, that means that you really have no obstacle to the registration. One question to the Chief Financial Officer. Do you pay negative interest on your huge cash balances? Interest on this. So we're looking for a solution for that. Right now, it's about 0.04 negative. We had cash and deposit with Irish banks, and only up to about a month ago, they weren't charging us. But that's changing now. But on the other hand, if we're holding U. S. Dollars, we have the FX risk. So our key priority was to eliminate that risk. The first question from the phone comes from Javier Taremburger from AWP. Please go ahead. Yes. Thank you for taking my question. Good morning. It's just a quick one on Metiline. And maybe you could just comment on what exactly the FDA didn't like about the results you showed them? And the other one is in terms of the generics you mentioned. So what exactly are we to expect in terms of sales development in the course of this year and then next year? Thank you. Okay. About the first question, what I can tell you is that and even more ironically, there is nothing that the FDA didn't like in the trial that we did. Just to be clear on this point, during the first meeting that we had after the complete response letter, we asked the FDA if they would stand by the SPA or they would rescind it because they also have the option to rescind the SPA if they think that for whatever reason the spa shouldn't be there anymore. And they answered us that they stood by the spa and so the spa was completely fine for them and they had no question whatsoever on the outcome of the trial. If I should summarize what the FDA has been saying, it's the following. Well, you know that normally the regulatory confirmation of the first one. So you're normally not allowed to register a drug with a single trial because the single trial may have happened by sheer chance. So they say, well, you're going to do a second one so that we're sure that the results that you have seen in the first one are not just by pure chance. This is fair enough. These two trials, they don't even need to have the same endpoints or be identical trial. They could be very different. Aimcolo is a perfect example. We had 2 trials, 2 pivotal trials for registration. 1 was a superiority versus placebo. The other one was non inferiority versus Cyprus. So this is the way that normally drugs are registered. If you look at Winlavi, the acne drug for of Casiotea, There we have an SPA in place, a special protocol agreement, but we have 2 trials. So this is the rule. Now you can also, in exceptional cases, you can have drugs registered with a single trial. And then what is required is that you need to have a single trial. And then what the FDA calls confirmatory evidence. So you need to have some additional confirmatory evidence that shows that what happens into the trial is not again sheer chance. And for us, the confirmatory evidence was adamantly clear. We had more than 30 years of experience in chromendoscopy, where dyes were administered through a rectal route and sprayed on the walls of the colon to highlight the detention of non polyposite lesion. This is exactly the confirmatory evidence for us. The FDA, however, this may sound weird, but certainly frustrating, then they then said, well, you know what, because you're administering the dye through a rectal route in chromendoscopy, we cannot consider that confirmatory evidence. We said, but then you should have told me this 5 years ago, Why you're telling me can you tell me this now? It's questionable whether this is correct. It's the same dye that's been delivered through a rectal route. I'm simply putting the dye into a tablet and administering it orally, but the effect that they want to produce and the mechanism of action is exactly the same. They questioned that. And so they said, you know what, I'm not sure that because you're delivering the directly, this is really confirmatory evidence. So you have one single trial, which is excellent, but I don't see the confirmatory evidence. So please do another one. It's put it that way, it's very simple, if you wish. But it's also very disappointing because it was clear from the onset that our, call it this way, predicate confirmatory evidence, what has been done in the prior 30 years. And we actually were leveraging on that experience because of the way chromendoscopy was administered. We said, let's put it into a tablet. It's going to do the same effect, but it's going to be much easier. The FDA questioned that CHROME endoscopy was sufficient as confirmatory evidence. So they said, your trial that you've done is perfect. You just do another one so we get the confirmation that we need. And they said we need this confirmation because methylene blue is going to be taken by millions and millions of people. We just don't feel comfortable now that you will go with a single trial. And then, of course, we could have said, yes, but this is exactly what you had agreed upon in the SPA, and it would have been a vicious circle. So we decided to interrupt the vicious circle, and we said, yes, now we know enough. We can go for the 2nd trial. We didn't say thank you. And sorry, the second question was about the generic sales impact? Exactly. What do you expect from I mean, they have impacted already Yes. We don't expect expect things to change. And if you have seen the slide on the guidance, I think that's going to be sufficiently precise because it's not foreseen that other generics will enter either in the Lialda franchise or the U. S. Airis franchise. So we expect that the sales will be more or less the same. We're looking at this for we're modeling in a further decline because you see the full year impact of the Acerus generic into next year, but that's in the guidance. We actually if you've seen the guidance is projected for 20 19, a 10% decrease in overall volumes. You have it here basically. So you see I think this tells you, you see the royalty would go from 15% to 10%. The products marketing will go from 28% to 26%. This is roughly the impact that you see in the decline of the overall revenues that will go from 66% to 60% in what we believe is a worst case scenario. Okay. Thank you. Thank you. There's another question. The next question comes from the line of Christian Glenny from Stifel. Please go ahead. Mr. Glenney, your line is open. Please go ahead. Hi, good morning. Sorry, I was on mute. Thanks for taking the questions. Just first one is on Cayelo in the U. S. Just to confirm in terms of potential timings of launch there And what sort of sales force is behind that in the U. S? The launch of Aimco is projected around June. And for the reasons that we'll explain at the R and D Day, you will also have the information on how the sales effort will be deployed. Okay. And then a couple just on R and D expectations. Obviously, 2019, the sort of probably the key trials or the main trials don't necessarily get fully underway. But what is your expectation around the cost of the additional MMX trial and the Phase III IBS D for Aimcholar? Well, I think the MMX trial will probably be around 10,000,000 and I think that the Phase III of IBS D will be less than 20,000,000. Okay. Thank you. And then just finally on IBS D, the data, the timing there and the likely format, is that a press release with initial results? And then a follow-up with a scientific conference. Yes, exactly. We hope that we will be able to deliver the data by year end. Okay. Thank you. Thank you. Okay. And some more specific questions on METEOLAN LUE on this new trial. You said that the issues have been resolved. So for example, you said that Metrolon 1 issue in the CRL letter was that Metrolon Blue stains 83% of the column. And how do you intend to address this issue? And do you know now what FDA meant by this? And then another question, for example, there was the issue with classification that Metturin used not the diagnostic device, but the visual enhancer. So how did you solve this issue? I think that this has been the last one is the most important one. I think that it has been clarified that we don't detect the nomads per se. We never actually claimed this, but for whatever reason that I cannot fathom, the FDA believed that Metaline blue MMX was somehow selective in being picked up only by adenomas. And therefore, they were wondering what the mechanism of action was. And I think that it was clarified in a satisfactory way that actually we had never ever claimed that. We're simply a conscious agent that enhances the overall vision and that therefore this makes possible the overall increase in lesion detection and as a function of this, an increase in the adenoma detection rate. And in fact, if you look at the data of the trial on how more effective MEDLIAMBLUE is in detecting lesion and detecting non poly polyposisone, you clearly understand that the increase in the under normal detection rate is an effect of being able to detect more lesions. So I don't think that this was that this is any more under question, which is why we hope that we'll be able to shift now the attention in the next trial on the detection of non polyposia lesion. And as I was explaining, it's exactly the same thing as in Aimcolo. You don't need to have 2 identical trials pivotal trials to do to have a registration in the case of Incolo. They had very different endpoints and still the drug got its registration because the clinical program was agreed upon with the FDA. And when you file at the same division? Yes, of course. And what else It may not be ideal, but the division for medical imaging products. And right or wrong, methylene blue is deemed to be a medical imaging product. Okay. And do you want to detect the missing rate? And if yes, how do you consider to do this? Well, if you end up detecting more lesions in the blue arm than you would detect in the white arm that clearly shows that there's a missing rate in the white arm that is reduced in the blue arm. But usually when you do colonoscopy trials that you have kind of tandem colonoscopy. First you go with the device with with blue land, let's say, and then Yes. But this is something that you can do with device, but you cannot do with methylene blue because methylene blue takes hours and hours to interact. So in case of colonoscopy device, you can do the tandem colonoscopy because you basically do the colonoscopy first without the device, then you do it with the device, but the scope is always inside the patient. So this is why you can do tandem colonoscopy. You cannot do tandem colonoscopy for MET and BLUE. And actually there were ethical reasons that were raised during the discussion of the original protocol because in order to do a tandem colonoscopy, you would have needed to expose a patient to 2 subsequent colonoscopy in a very short timeframe and the strength was not doable because colonoscopy is actually considered a dangerous procedure. You have to sedate the patient. You have to go inside the patient with the scope, with the disc of perforation, so you cannot really perform with tandem. So you can exclude that this will be kind of issue. This is clarified I exclude because now we have a landmark protocol, which is the protocol that we had agreed in the special protocol agreement that the FDA says it stands for. So I think that all the main features that were agreed upon in the original trial to protect the blind and to make sure that everything was done coherently will also remain in the second trial. That's clearly an experience that won't be wasted. And out of interest, what was this Metulane blue stained 83% of the column? No, this was an example that I made to you in a discussion that we had. 1 of the issues that the FDA raised in the complete response letter that fortunately was not an issue anymore is that they were wondering why methyl and blue stain only, they said, 83% of the regions of the columns. And we just clarified, 1st of all, that this was a fantastic result because given the fact that all patients have different bowel movements, different they might have drink or not, different quantities of prep, they might or might have not taken the tablets at the same moment during the day. The fact that there was such an uniformity that 83% of the regions of the column were staying was actually a fantastic result. And besides, nowhere in the protocol it was stated that it should have been staying more or less than that amount. That was simply a statistical data that was asking for compliance reason, but had no impact whatsoever, neither on the detection nor on the outcome nor on the results on the individual endpoints. Yes. But the FDA, they must have had a reason to state this. Well, you see this is the problem. You have a lot of the geniuses have decided to go to work for the FDA. Maybe some of them are not 100 percent geniuses. As the people that work for Cosmo actually or that work for the Swiss banks, I'm not sure that every single one is a genius. So I'm not necessarily the one who asked it. The 8% to 3% question is a genius. I still don't understand it. Okay. I was just asking because you now all the issues should be clarified. And this is one of these issues. Yes. But please take my words with some grain of salt. I said that I believe we know now the path forward. I haven't said yet that the FDA agrees on the new protocol. I said that we believe we know how to present the new protocol now. FDA will come hopefully subsequently, right? Okay. Thank you. We are done. Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call and thank you for participating in the conference. You may now disconnect your lines. Goodbye.