Ladies and gentlemen, good morning or good afternoon. Welcome to the half-year results presentation conference call. I am Alice, the conference call operator. I would like to remind you that all participants will be in listen-only mode and the conference is being recorded. After the presentation, there will be a Q&A session. You can register for questions at any time by pressing star and one on your telephone. Should you need assistance, please press star and zero to get an operator. The conference must not be recorded for publication or broadcast. At this time, it's my pleasure to hand over to the management team of Cosmo Pharmaceuticals. Please go ahead.
Good morning and good afternoon, everyone. This is Alessandro Della Chà from the Cosmo headquarters. Happy to have the chance to talk with you about what happened in the first six months of the year. I'll make a quick introduction and I'll tell you about the key events. I'll pass the word to Niall Donnelly, our CFO, on the half-year financial review. I will update you on products and R&D, and I'll spend a few words on 2018 outlook and forecast. There will be then a session for questions and answers. Quickly going through the key events of the first half of 2018. We have unfortunately received, as you all know, a Complete Response Letter from the FDA in relation to our Methylene Blue MMX NDA application. The NDA has not been approved in the current form.
We have presented an extensive briefing package, and we asked for a Type A meeting. The Type A meeting was held yesterday with the FDA. The Type A meeting is a formal event that needs to take place before the formal dispute resolution process provided by the FDA statutes can be put in place. The outcome of the Type A meeting will be communicated once available. Typically, the FDA may require up to 30 days before they can issue the minutes of the meeting, which will contain the final decision of the division. Starting from the moment the minutes are communicated, we will have 30 days to file an appeal above the division level. Our Rifamycin SV MMX NDA has progressed nicely. We have had a mid-cycle review at the end of June.
The PDUFA date continues to be set on November 16. By the end of August, we should start the labeling discussion. I just remind you all that Rifamycin SV MMX enjoys a Fast Track designation, and this is why we have already been informed about the date where labeling discussions should begin. The Rifamycin SV MMX phase II proof of concept study in IBS-D is progressing as expected. Our Eleview gross sales in the U.S. reached EUR 4.6 million in the first half versus EUR 2.1 in the second half of 2017. Here we're comparing the first half of 2018 with the second half of 2017 because sales started in July 2017. We've entered into a license and supply agreement with Pharmascience, one of the biggest drug sellers in Canada for Eleview, methylene blue, Rifamycin, and Qolotag.
We have also entered into an agreement for the sale of Eleview with Fujifilm expanded to Southeast Asia, Middle East, Africa, Australia, and New Zealand, and Cosmo still to receive 45% of gross revenues from this sale. We have also entered into license supply agreement with EA Pharma for Japan and South Korea for methylene blue and Eleview with an option for Qolotag as well. Notably, our associate Cassiopea, of which we own 45.09%, has communicated a sequence of very good news, including the successful phase III clinical trial outcome of the drug Winlevi for the treatment of acne, and very encouraging result from the interim analysis of the phase II dose ranging study ongoing for Breezula.
Breezula, I will remind you, is the same drug in a different formulation that's used for the acne treatment, and in the case of Breezula, it's used for the treatment of androgenetic alopecia. It should be noted, as at the 34th of July, Cosmo's stake in Cassiopea allows a market value of EUR 193 million compared to EUR 134 million as at 31st December 2017. ICC tribunal in April ruled that Valeant was not in breach of the Uceris license agreement. This has caused a disbursement in terms of legal fees we had to pay to Valeant that's been accounted for. I will now pass the word to Niall Donnelly, our CFO, for a quick financial review of the first half. Niall, please go ahead.
Thank you, Alex. In the first half of 2018, our revenues are up 15.2%. This is largely driven by upfront license fees in relation to the Pharmas cience deal, which Alex has referred to. In the first half, our operating costs were up 21.4%, and this is mainly due to the buildup of our U.S. organization. Our operating loss for the period was EUR 7.2 million, and this compares to EUR 4.3 million in the same period last year. In the first half, we saw a strengthening of the U.S. dollar against the euro, and this has resulted in an FX gain, which is the main reason for a net financial income of EUR 4.8 million in the period. Our loss for the period is EUR 7.8 million, and this includes our share of Cassiopea's loss of EUR 2.9 million.
At the end of the period, we had cash investments of EUR 230.2 million, and this compares to EUR 247.1 million at the year-end. Our total assets at the end of the half year were EUR 479.6 million, and our equity was EUR 456.4 million. On slide nine here, we have our income statement. On the next slide, I will take you through the revenue in some more detail. In the first half, we have seen a 10.9% increase in net sales of Uceris up to $69.7 million. Our total income was EUR 13 million, compared to EUR 12.1 million, an increase of 7.4% over last year. Cortiment is doing well under Ferring. Net sales increased there by 14.3%, up to EUR 7.2 million, and our income increased from EUR 1.4 million up to EUR 1.8 million, up 26.5%.
In relation to Lialda and Mezavant, with the launch of the generic in the U.S., we've seen a drop in our manufacturing income here. This is partially offset by an increase in income in Japan and Europe. But overall, we have a EUR 2.2 million reduction in income there, down to EUR 10.6 million in the first half. In relation to other income, our generic income is steady, and we've spoken about the license fees and upfront milestones in relation to the Pharmascience deal. The next slide, 12, shows the performance of Eleview in the first half of this year. We have shipped 10,656 units to end customers. Each unit contains five vials, and this compares with 5,224 units in the second half of FY 2017. Our net income in euros was EUR 2.8 million. Our growth sales is EUR 4.6 million, and this compares to EUR 2.1 million in the second half of 2017.
In relation to our operating costs, they were EUR 43.9 million versus EUR 36.1 million in the same period last year. The increase is mainly due to the buildup of our U.S. organization, which is now generating sales and also preparing for the launch of Rifamycin SV MMX in the first half of 2019, which is, of course, subject to regulatory approval. Our net finance income was EUR 4.8 million in the period, and this compares to a net financial expense of EUR 11 million in the same period last year. This is mainly due to the strengthening of the U.S. dollar against the euro. The loss of a share of Cassiopea's result is EUR 2.9 million versus EUR 4 million in the first half of last year. In terms of our balance sheet, at the end of the period, we had total assets of EUR 479.6 million. We had equity of EUR 456.4 million.
On the next number of slides, I'll take you through some more detail in relation to our balance sheet. First of all, in relation to our cash and financial assets. We held cash of EUR 84.3 million at the end of the period. We held total non-current and current financial assets of EUR 161.4 million at the end of the period. Our cash, bonds, and investments and funds is EUR 230 million at the end of June, and 30.7% of these investments are held in U.S.-denominated investments and in U.S. dollar cash deposits. We've reduced our dollar position in the first half because of the delay of the methylene blue launch and the corresponding reduction in the expense forecast for the U.S. operation.
In relation to the investment in Cassiopea, as Alex has referred to earlier, our stake was worth EUR 193.5 million as of 24 July, following the recent good news there. We have other current assets of EUR 29.2 million. There's an increase here of EUR 4.7 million, mainly working capital increases. In relation to other non-current assets, we have EUR 71.7 million. No real change overall, but we've an increase in intangible assets, which is broken out on the next slide. The increase is mainly due to registration costs associated with Rifamycin SV MMX. At the end of the period, just to summarize, we've total assets of EUR 479.6 million, total liability is EUR 23.2 million, and our equity is EUR 456.4 million. On this note, I'll hand back to Alex for the products and R&D update.
Thanks. The first item is Methylene Blue MMX. As said, we received our Complete Response Letter on May 22nd. The NDA was not approved in the current form. The Type A meeting request was filed together with an extensive briefing package. The Type A meeting took place yesterday. The outcome of the Type A meeting will be communicated once available. I just want to stress the point that this meeting had occurred in front of the very same division that issued the Complete Response Letter. The formal dispute resolution process provides for appeals to be filed, as they say, above the division level.
The Type A meeting is the formal conclusion of the portion of the process in front of the division that has issued the Complete Response Letter. Therefore, for dispute resolution process purposes, the file will need to be moved upward in the chain of command of the FDA. This is what is going to happen in the context of an appeal. I don't think I have to tell you again, what are the expectations around Methylene Blue MMX, or what the performance of Methylene Blue MMX are, because this comes from data that has already been released. What I can tell you is that we're confident that in a way, one way or another, we will be able to sort out the issues with the FDA.
We believe that we have a very strong case. Our position is supported by our regulatory consultants and attorneys that are helping us in dealing with the FDA. We believe, and in summary, that the concerns that have been raised by the FDA are fully addressable without the need of a second trial. Then we will continue to pursue regulatory approval for the product. In terms of Rifamycin SV MMX, the FDA, as said, has accepted our NDA submission. The due by date continues to be set on November 16. At the end of August, we will start the labeling discussion. Therefore, the pre-commercialization activity in the U.S. is underway. The launch is expected at the beginning of the first half of 2019, clearly subject to regulatory approval.
In the meantime, Dr. Falk Pharma has filed for the marketing authorization of Relafalk 200 mg in Germany as reference member state through a decentralised procedure. Dr. Falk is informing us that the review process is going very well. The response, meaning the issuance of the marketing authorization, is expected by the end of the fourth quarter of 2018. In the meantime, our IBS-D phase trial started on October 17. This involves 25 sites and 342 patients. The first patient was randomized in December 2017. The trial end right now continues to be expected by the end of 2018. This should trigger an estimated eight years of regulatory exclusivity as a new molecular entity under the QIDP for the additional IBS-D indication. remimazolam is also progressing well. We are currently in the phase of producing the validation batches with Patheon, that's our external contract manufacturing organization.
The NDA filing here you see is expected by end of Q1. Actually, according to our plans, the NDA should be filed by January. remimazolam will come together with the five years regulatory exclusivity as new chemical entity. I just want to remind you that there are already six patents granted, the last expiring in 2033, not counting the patents that have been filed in the meantime. In terms of outlook and forecast, Eleview continues to be substantially on track. We're not specifically very happy about the performance of Olympus under the agreement. We are expecting Olympus to do more, specifically, there is a promotion that Olympus has undertaken to start, which should begin soon. Which should have begun already, actually. Now they're telling us it will begin at the beginning of August.
The market opportunity remains the same and also our expected level of sales for 2018. There has been an expansion of the Eleview franchise with the agreement for Fujifilm for distribution, as I said, beyond Europe and South Africa, Southeast Asia, Middle East, Africa, Australia and New Zealand. Fujifilm is planning market launch in the second half of 2018. Actually, their sales should start, they told us, at the end of July/beginning of August. Just let me recall that Cosmo will receive 45% of gross revenues as compensation, including supply. Clearly, also, the Methylene Blue MMX U.S. market opportunity remains as stated, although unfortunately, the product has not been approved yet. The product was extensively presented at the 2018 DDW in Washington. Because of the important advancements in the colonoscopy that it grants, it was reserved the place of honor in the presidential session at the DDW.
I was there to attend the presentation, basically, there was only standing room because all seats were occupied and the presentation was greeted with utmost favor. Rifamycin SV MMX U.S. market opportunity also continues as previously described, the same is for the remimazolam U.S. market opportunity. Here, in our presentation, there's an extensive examination of the pros of this drug and our market analysis, which is being made prior to launch, confirms the fact that this is going to be a very much needed drug in all contexts of procedural sedation. A quick update on Aries. Aries now is currently being run by 85 persons, 61 in markets and sales, 10 MSL, and 14 in management and administration. We're in the process of optimizing costs there.
We don't expect guidance for 2018 to change because while there may not be Methylene Blue MMX revenues these years, there also won't be the associated product launch and sales force costs. The U.S. market opportunity for all four products in the pipeline continue to be extraordinarily compelling. Our key priority in 2018 will therefore be to address issues with the FDA regarding methylene blue, to progress rifamycin in order to see it hopefully approved by the PDUFA date of November 16. Also progress the rifamycin IBS-D trial. File remimazolam NDA, maybe we'll be able to accelerate the filing further, continue the partnering of our pipeline in the rest of the world. Thank you so much, I guess that now it's time for Q&A.
We will now begin the question and answer session. Anyone who wishes to ask a question may press star and one on the touchtone telephone. You will hear a tone to confirm that you entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to remain silent while asking a question. Anyone who has a question may press star and one at this time. First question comes from Bob Pooler, valuationLAB. Please go ahead.
Hello. Good afternoon, gentlemen. Just if I may, a few questions. First, on the meeting yesterday on methylene blue. Were any concerns or issues that are raised by the FDA, were they already raised yesterday, or is this something that will go later in the formal dispute?
The FDA didn't raise yesterday, actually, any comments further from the comments that were already raised in the Complete Response Letter. Yesterday's meeting was just dedicated to us representing the case to the division. Actually, there was an extensive presentation that was made in the context that contained also a further illustration of our answers to the queries that were made in the context of the CRL. We will wait for the outcome. As I said, it may take up to 30 days to receive their minutes. Upon reception of the minutes, it will start a 30-days period to file the appeal above the division level.
Okay. Yesterday was just still more formality than actually getting more insight into what the FDA's action, what the issues are.
Yes, we were not expecting any specific outcome for yesterday meeting, also because we were substantially pleading the case in front of the very same people that had issued the Complete Response Letter, and that also received our answers to their concerns. They told us that it would take them 30 days to elaborate an answer. I don't think that there's any specific reason to assume that they will change their mind, which is the reason why this type of meeting is actually a more formal step in order to access the formal dispute resolution mechanism.
Okay. Very clear. Thank you, Alessandro. On the MAA filing, that's still planned for Q4 this year?
Excuse me, which filing?
The MAA filing for methylene blue in Europe. The European filing.
Yes, absolutely.
Thank you.
That's scheduled by November.
Okay, November. Just on the Lialda now with an authorized generic. Is there any possibility that you could, in the contract with Shire, that you could launch also your own generic, you might have better economics on that?
Not our own generic, because this is basically precluded by the existing agreement. No, we don't have a chance of launching our own generic there.
Okay. If I may, just on Qolotag, what is the status in the EU where it is approved, and are you proceeding with the US on the regulatory procedure there?
Could you ask again, please?
On Qolotag.
Qolotag, yes.
Qolotag, yeah. The status in EU, where is it now? It's been approved. Are you-
Oh, yes. It has been approved in the EU, and it's being tested in the U.K., because that is going to be the most significant market where sigmoidoscopy is widely used as an alternative to colonoscopy.
Mm-hmm. When would you expect first sales?
I think that's premature. Probably not before a year, I think, it's going to take at least a year. We're working in cooperation with the University of Oxford to prepare additional testing to put that into the context of the national program that's being used in the U.K. for sigmoidoscopies.
Yeah. Okay. A final on rifamycin. You've been also looking into the market there, and you've said also in the presentation that price could be a level or a leverage. Any feedback from the insights from this marketing efforts on rifamycin, what the potentials are and maybe some of the striking that came out of the marketing efforts at this moment or the pre-marketing efforts?
Well, basically, we think that we would have our positioning there with a price that will be similar to that of Xifaxan. I don't exclude that this has been confirmed by our market analysis and market research. I expect that if we want to position ourselves nicely in the market, we may want to be a little more aggressive there and make sure that we can give more value for money.
Okay. Thank you. Thanks for answering the question.
Thank you.
The next question comes from Joseph Lackey from Berenberg. Please go ahead.
Thank you. Alessandro, I appreciate you can't give us much of an update yet on methylene blue. Can you help us to understand the potential scenarios? You said you believe the issues are addressable without the second trial. Is the second trial still a possibility, or do you think this is now an all-or-nothing decision? Can you give us any detail on how straightforward the FDA's issues are to fix? Thank you.
Yes. As I think I said already, I'm happy to repeat it. Because of the way the regulatory environment is framed, you cannot simultaneously decide to run a second trial and pursue the regulatory appeals. We believe, upon the advice of our regulatory consultants and attorney, that it makes way more sense right now to pursue the regulatory appeals rather than start the second trial. While starting a second trial is not ruled out, it wouldn't be really a viable option if you believe that you have a good case for appeal. Our feeling, together with the feeling of the consultants, is that we have a very good case for appeal.
I don't think that the issues that have been raised by the FDA in the CRL actually are addressable with the second trial because they are more, as we may have also already discussed with some of you over the phone, these are basically more basic understanding issues rather than real regulatory issues. As I said, one of the issues that was raised in the Complete Response Letter is that we have not given evidence that methylene blue MMX finds adenomas per se. We stated very clearly, I believe, in all the NDA process, but also in the documentation that was filed after the Complete Response Letter, that we do not find adenomas per se. What methylene blue does is methylene blue enhances the detection of lesion, and because you detect more lesions, you end up detecting more adenomas, and therefore you increase the ADR.
This is typically not an issue that you can solve with a second trial. This requires a mutual understanding of what the drug is supposed to do.
Okay, thank you. That's very clear. Just maybe following on from that, what would be your strategy for the appeal process? What will be your tactics to get that message across and help them get onto your side?
Well, as you know, Joe, I'm not aware of companies disclosing typically the content of the Complete Response Letter. In this respect, you kind of have to take our word at face value when we tell you that we don't think that those issues are addressable with the second trial, while we believe that all those issues are perfectly addressable just looking at the available data. The strategy is relatively simple in the sense that the letter is called Complete Response Letter because it sets the perimeter of the issues to be discussed. There's no chance that the agency can bring further issues, meaning issues further to those that have been disclosed in the Complete Response Letter. This is the reason why we, together with our consultants, believe that we have very good grounds.
If the issues that the FDA is concerned with are the issues that are listed in the Complete Response Letter and no other issues can be added to those, whatever those may be, well, then I think that we have a very good case.
Okay. Thank you very much. Maybe just one quick one on Eleview. It sounds like it's perhaps launching slightly slower than you expected. Can you give us any split in sales contribution between Olympus and Aries there? Maybe just give us a degree of confidence on achieving that $12 million in the U.S. by the end of the year.
Well, actually, I think that we have said $12 million, we are now around $5 million. The promotion that we've been waited for Olympus to start has not started yet and should have started already. My expectation is that with that promotion that's supposed to start in August, we should reach the level that we were envisaging. What I may say is that clearly it's more difficult to launch a product, however strange this may be. It's more difficult to launch a product in the context where you have no competition at all, rather than in a context where competition is already there, simply because you need to create a market when there's no competition. Whereas when there is competition, you can kick in with better pricing, with more aggressive comparison.
Here, we're comparing our Eleview with saline solution that into the mind of the practitioner doesn't cost anything. We're trying, first of all, to convey the message that even though they may think that saline solution doesn't cost anything, that's absolutely not true. Actually, it does cost a lot if one does the right accounting. There's also the sentiment that right now a lot of endoscopists may just wish to reserve Eleview for their more difficult cases, therefore somehow limiting the use, and we're trying to work with our marketing forces on this to make the use of Eleview as extensive as possible. Clearly, we are pioneers here, so we're creating a market, and this could be the reason why it may take a little longer than expected.
Okay. Thank you very much. Very clear.
The next question comes from Peter Welford from Jefferies. Please go ahead, sir.
Hi, thanks for taking my question. Firstly, on Uceris. With the recent FDA approval and then launch of a generic, I think an authorized generic is also available now. Firstly, are you also manufacturing, can you confirm the authorized generic for Valeant? And secondly, can you just outline why you and partner Valeant chose not to pursue a restraining order around that launch and what the current timeline is for the ongoing legal process there? And then secondly, returning to methylene blue, if you were to file an appeal above the divisional level with the FDA, can you just give us a framework for the timeline then as to the FDA then responding? Typically, how long does the agency then have to get back to you? What is the process, and how should we consider things developing from there? Thank you.
Hi, Peter. Thanks for your questions. Well, about the first one, yes, we are manufacturing also the authorized generic. We're not sure that Teva is really willing to pursue this launch in a very aggressive fashion. Valeant is telling us that currently they're not seeing a significant drop in sales. Well, the launch from Teva, as you all know, has been at risk because the appeal process is still pending and if they're found in infringement, they would be exposed to the obligation to pay very significant damages. Our feeling is that it is also possible that they made this launch in order not to lose their priority status as first filers under the ANDA rules. This could be the reason. In terms of why a restraining order has not been filed yet, this is more of a matter of strategy.
I'm not sure it makes sense that I discuss the legal strategy in this conference call, but it is also possible that because the appeal is pending, there's no specific willingness to let Teva profit of a very rapid decision on whether they can continue their sales or not. The fact that they continue to do that at their own risk is clearly exposing them to an obligation to pay damages that increases on a day by day. I hope this answered your question.
No problem. Thank you.
In respect of the process, the lawyers and the regulatory consultants are very cautious in telling us how long they think the appeal process may be. I think we have already said around six months and I would keep this six months only bearing in mind that the six months will start from the moment the appeal is filed. Assuming that we receive the minutes by the end of August, we could receive them on an earlier basis and actually we have already started to draft our appeal. Assuming that the minutes arrive by the end of August, we will then be filing our appeal let's say by the end of September and you will need to count six months from there.
As a reminder, if you wish to register for question, please press star and one on your telephone. The next question comes from Barbora Blaha from Credit Suisse. Please go ahead.
Hi. Thank you for taking my question. I would like to have a bit more light on the gross sales and net sales of Eleview because second half of 2017 the net sales were EUR 1.5 million and the gross sales were EUR 2.1 million. This last half year the net sales were EUR 2.8 million and EUR 4.6 million. What does it include and why did the difference grow and how should we think about this going forward?
Sure. Well, you have to keep in mind that we're paying Olympus a 25% royalty on gross sales. First of all, you need to account for that transaction and then you also need to account for the swings in the FX. That's basically the reason why.
Also this is the only reason, this FX?
Yes. FX and the 25% royalty to Olympus.
Who's booking the sales? Are you booking the gross sales?
Yes, we're booking the gross sales and we're paying the royalty to Olympus.
Okay. After the royalty it is net sales.
After the royalty it's net.
Okay. I have a quick question about the methylene blue manufacturing facility. What is happening with it right now? Is it on hold?
We're keeping it warm.
Okay. Maybe quickly about Aries' guidance because you reduced the guidance in term of OpEx from EUR 80 million to EUR 50 million. How should we think about this? Will you cut further headcount or will this stay more or less constant?
No. Well, as you can imagine, we're keeping all the Aries' cost at bay and then the drop that you see in the projected cost is due to the fact that as we're not launching methylene blue this year, there's going to be substantial savings and specifically, no cost for launch and no cost for hiring all the additional reps that we would have hired. Of course I would have loved to spend the money that I said that we would have spent, but this is not going to be the case, so we're trying to control the cost at Aerys as much as possible. Yes, you may expect some further cuts if we will be able to apply them. Just keep in mind that it is also difficult to intervene in a drastic fashion on the cost structure of Aerys, because we're getting ready to launch Rifamycin anyway.
There's a balance in there in the fact that not only we need to keep the sales and marketing organization as efficient as possible, but we're also projecting it increase upon the approval of rifamycin.
Okay. Thank you.
The next question comes from Anders Schneider from Orpheus Capital. Please go ahead.
Hi. I would have some add-on questions on the methylene blue trial. You mentioned quickly this one issue, so this basic understanding issue the FDA have. Can you give us further details? You said before that you discussed with some before. I would be interested also in some details to better understand what happened.
Well, some of the issues would be really complicated to discuss over the phone, given the fact that the company has decided, as all companies do, not to disclose the Complete Response Letter. It's really very difficult for me to give you further details in this respect.
Well, what would be the reason for you not to disclose the details or further details? Does it have some competition? Is a competition issue, or does the FDA prohibit you to do that? What would be the reason?
Yeah, I think they're basically very technical. I think everyone will be extraordinarily puzzled unless someone is a very expert endoscopist or a statistician. Therefore you will be wondering, what the heck does that mean? Probably you will be left with more question by reading the Complete Response Letter than not reading them, which may be the reason why companies normally don't disclose them. It's not because there's anything specifically to hide. It's just because I think that they would raise more question than the answer that they would give.
Can you tell us the number of issues which were at the FDA?
Five.
Five.
There were five, but as I said, which is very important, this was stated in our press release, and I would like everyone to keep this in mind. The FDA did not raise safety issues. The FDA did not raise manufacturing issues, which are the issues that could typically kill a project. They simply said that they were not convinced that the results were robust enough, whatever robust may mean, actually. Therefore, this was the reason why they were asking for a second confirmatory trial. The FDA stated, this was also reiterated in yesterday's meeting, that they don't have anything to argue in respect of the trial that's been completed. They said the trial was well conducted, well controlled. No question that we reached the statistical significance. They're simply assuming that what they're saying may not be related to the drug, and therefore they're asking for a second trial.
Normally, the reason why you have two trials in an approval process is because the second trial is supposed to be the confirmation of the first. They assume the first trial may have results that happen just by sheer chance. They want to see the results being repeated in a second study that, for this reason, is called confirmatory trial. Why they may have this doubt, considering the fact of how strong in statistical terms our results are, I'm puzzled, and so our consultants are puzzled as well. I'll give you an example just for a better understanding. Typically, the FDA would say that the results are not robust enough in a context where the company barely reaches the p-value that are required for a successful outcome.
These p-values could significantly change by just swinging or shifting one or two or three patient from one side to the other. This is typically the context in which one would say, "Well, the results probably are not robust enough because your conclusions are relatively weak and subject to change depending on the shift of a few patient." This is clearly not our case. I'll give you an example. On the primary endpoint, according to the agreed statistical analysis plan, the minimum p-value required was 0.05. Then if you do the calculation the way the FDA requested with the logistic regression model, our p-value is 0.01. It's five times less than what was set as a minimum by the FDA. This is just an example.
You say the robustness of the outcome and also how you conducted the trial and how it was made, that there were no issues with that?
That's the way we see it.
Okay. Just last quick one. Could you remind us what the cost of the phase III trial of methylene blue was?
I think it was in excess of EUR 25 million.
Okay, thanks.
Once again, to ask a question, please press star and one on your telephone. Star followed by one. Gentlemen, there are no more questions at this time.
Well, if there are no further question, I thank you all for your time and the attention that you gave to this matter, and I hope I'll be able to meet each of you personally in the near future. Thank you so much.
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