Dear ladies and gentlemen, welcome to the conference call of Idorsia regarding the half-year financial results presentation 2021. At our customers' request, this conference will be recorded. As a reminder, all participants will be in a listen-only mode. After the presentation, there will be an opportunity to ask questions. If any participant has difficulties hearing the conference, please press star key followed by zero on your telephone for operator assistance. May I now hand you over to Andrew Weiss, who will lead you through this conference. Please go ahead.
Thank you, Angela. Good morning, good afternoon, everyone, welcome to the Idorsia webcast to discuss the first half 2021 results published this morning at 7:00 A.M. Central European summer time. With me on the call to provide additional granularity on our operational, clinical, and financial advancements over the first half are our CEO, Jean-Paul Clozel, our CFO, André Muller. They will be making prepared remarks. For the Q&A session, we will be joined by our Chief Commercial Officer, Simon Jose. Next slide. Before handing over the mic, a few customary remarks, i.e., we will be making forward-looking statements in this call, which may or may not turn out to happen. Hence, you have been appropriately warned about the risks and benefits of investing in Idorsia shares. Next slide. Without further ado, Jean-Paul, the floor is yours.
Thank you very much, Andrew. During the first six months of this year, Idorsia has made tremendous progress to become a fully fledged biopharmaceutical company. Next slide. If I see the main highlights of this first half, you will understand why I feel so confident that we're on the good track. As we have discussed already with you, the daridorexant NDA has been submitted in the U.S., the EMA has been submitted in Europe, the submission has also been made with Swissmedic. Ponesimod, which is a drug Ponvory , sold by Johnson & Johnson, has been approved in the U.S. and in Europe, which shows the quality of the clinical program, which was set up by Actelion and by the team, which is now within Idorsia. The clazosentan NDA has been submitted in Japan.
Also, we have initiated the phase III study with the selatogrel for suspected myocardial infarction. In addition, within a few months, we are going to get the results of the phase III study, the pivotal study with the lucerastat and the phase II-B of cenerimod, while we will get the results of aprocitentan in the middle of next year. For aprocitentan, all the patients have been recruited. Next slide. When I mentioned to become a fully fledged biopharmaceutical company, what does it mean for us? It means mainly to fulfill five strategic priorities. These are the priorities we had from day one of the creation of Idorsia, and we have not changed these priorities. First, we wanted to deliver three products to the market, and I am not counting into these three products ponesimod.
You will see in the next slide the progress of the pipeline and why we believe we can reach and maybe be better than these goals. Number two, or the second strategic priority, is to build a world-class commercial organization. This task has been given to Simon Jose, and we are progressing extremely well in order to have this infrastructure which will allow us to market our drugs. Number three is to bring Idorsia as soon as possible to a sustainable, and I would say also to a growing profitability. We are doing everything that in the midterm we can really become financially independent. Number four goal is to continue to fuel our pipeline with new discovery from our own research. I always said that drug discovery is the engine of a biopharmaceutical company. It's like in a car.
In a car, you can stop the engine and you can continue to run, but you won't run very far. Without new drug discoveries, a company cannot really grow and cannot have a future. This is why it is so important for us to continue to build our pipeline by bringing new drugs within this clinical pipeline. Finally, the fifth goal of Idorsia was to utilize state-of-the-art technologies in every, I would say, departments or in every area of the company. You will see that we're using these new technologies not only in drug discovery, but also in clinical development and in marketing. Next slide. Let's look at the pipeline. Our goal was to put on the market three new drugs, and we are really well on the way. Daridorexant, our dual orexin receptor antagonist, has been filed, as I've mentioned.
The review is ongoing and it's going, I would say, very well. Aprocitentan is a dual endothelin receptor antagonist. It is for the treatment of difficult to treat or resistant hypertension. Aprocitentan, the study is fully recruited, and we will get the results in the middle of next year. What I have to say, I think that we've got more than five DSMB review, and we have not heard of any safety concern. Clazosentan is an endothelin receptor antagonist intravenous for the treatment of vasospasm or/and prevention of, sorry, prevention of vasospasm with aneurysmal subarachnoid hemorrhage. You have heard that we had very positive phase III in Japan, and we are going to get the results next year of the REACT study, which is more or less a similar study performed in Europe and in the U.S.
Lucerastat is tested in Fabry disease with a very interesting clinical protocol, which is evaluating not only the effect on the biomarkers, but the effect also on lucerastat of the clinical symptoms, especially the neuropathic pain, which is the main problem, clinical problem in this patient with Fabry. Selatogrel has been started the phase III study. We had an SPA with the FDA, which mean that the FDA agrees with the protocol that we are following for the phase III, and also with the way we are going to evaluate the effect of selatogrel in these patients. Cenerimod is our drug for lupus. It's a third generation S1P1 receptor modulator, an optimized S1P1 receptor. We are waiting the result of a phase II-B, which could, if the study is positive and show consistent results, be used as a pivotal trial.
Which mean that if the study is positive, we might have only one more study to perform before the NDA. We have also other drugs which are moving within our pipeline. I just can mention a selective orexin 1 receptor antagonist for binge eating disorder, which is recruiting in phase II, and some other products coming from our drug discovery, which are in phase I or close to initiate phase II. Next slide. Coming back to daridorexant. I have mentioned, and we have mentioned many times, that the results were very consistent and show an effect of the drug during the night, improving sleep, but also showing effects during the day, consistent with an improvement of daytime functioning. The drug is now in discussion, so we are answering questions from the regulatory authorities, and I think the process is going very well.
We really should be in a position to launch in the U.S. in the beginning of next year, this drug, and in Europe and Switzerland later on during the year 2022. Next slide. I've mentioned also that selatogrel has started a study in a very interesting new indication, which is really to give the patient the chance to prevent his myocardial infarction or to have it in a much less severe form. This can be obtained by having him injecting himself. The platelet aggregation inhibitor, which is selatogrel. It can inject with an automatic device. After that, he can call the ambulance, he can call the doctor, and then go into the hospital to be treated.
Usually, the time between the first pain and the time the patient is treated within the hospital is an average of three to four hours, depending, of course, if you are living in a big city or in the country. It can be, and you can imagine in the U.S., especially with very long distances, it can be six hours. We have agreed with the FDA that we are going to do a study where half of the patients will be treated with a placebo, half of the patients will get this auto-injector, and will be able to treat themselves while they have the first signs of a new myocardial infarction, because we are dealing with patients who already had a myocardial infarction, so they can recognize a second incident. Next slide. The second goal of Idorsia is to build a world-class commercial organization.
We clearly are putting priorities on three regions, the U.S., Europe, and the main countries in Europe, and Japan. We have established affiliates in the U.S. in Radnor, in France in Paris, in Germany in Munich, in Italy in Milan, in Spain in Madrid, in the U.K. in London, and for Japan in Tokyo. We have recruited the general manager, I have to say that I am very happy to see how many top talents we can recruit. Sometimes I wonder why we are able to attract so experienced people who have already launched several drugs, who know the market, who know the regulatory authorities, and who know the processes needed to succeed for a launch of new drugs.
Frankly, I think that the recent mergers, being Celgene with BMS, being Alexion bought by AstraZeneca, all these changes have created some opportunities for people to either choose staying within large companies or joining companies like Idorsia, maybe with a little bit more entrepreneurial, maybe a little bit more risk, but certainly, with a very different culture, more close to startup. Next slide. We want to utilize state-of-the-art technologies to drive innovation. This is, for example, used in drug discovery. I ntelligence Artificial is used now to select new drugs to help the drug discovery process. We try to make it something that is available for all the different departments in the drug discovery department.
Artificial intelligence, for example, is also used in clinical development to be able to best use our data sets and the millions of data points we have created by doing studies and, for example, chronic studies like daridorexant. We are trying to use the most modern technology to analyze this data and to also use this information to discuss, for example, with regulatory authorities. We are also using modern technologies for marketing. Today, social media has a huge impact. Today, it's possible to address, to select the doctors who are more likely to prescribe our drugs, but we can also inform the patients and select the patient by using the most modern tools, which can now allow to have a much better selection of the patient who require the type of drugs which we are developing. Next slide.
We want to continue to have a permanent inflow of new drugs within our clinical pipeline. This is really something which is very important. I do believe that with the drugs that we have now in late-stage development, we have potential for growth for the next 10 years. After these 10 years, we need to continue to grow. We need to have this long-term view, and the clinical development team needs to get every year one or two or three new drugs to test if we want to be able to market in the future, new drugs in addition to the very rich pipeline that we have already. This drug discovery organization is still based on the single center approach, focused on small molecules, organic chemistry, with a fully integrated research informatics, with multiple therapeutics areas, but focused on few platform of expertise.
For example, the G protein-coupled receptor, some enzyme, are our key expertise areas. Of course, with a very high medical input, w e absolutely want to develop drugs for succeeding high medical needs. Next slide. Finally, as I have mentioned, we want to bring Idorsia to sustainable profitability. How we are going to get there? Clearly, we are in a very particular situation because our revenue, we have two main streams. First, milestones and royalty streams, for example, coming from ponesimod, but also in the future, aprocitentan, and hopefully from the T-type calcium channel blocker, which has been licensed out to Neurocrine. We will have also our net sales coming from primary care, for example, for daridorexant, but also for orphan drugs like lucerastat, clazosentan, and specialty drugs like cenerimod and selatogrel.
All the organizations that we are setting up now to launch daridorexant and clazosentan in Japan is going to be leverage when we are going to have the results of the new drugs, and we are going to be able to launch other drugs in addition to daridorexant. Next slide. André is going to discuss the financial numbers from these first six months of the year.
Yeah. Thank you, Jean-Paul. As you rightly said, the preparation for the product launch with the daridorexant and clazosentan in Japan are well underway. Let's move, operator, to slide number 14. The usual slide on how our operating and net results came about. Starting from left, we see a revenue, actually CHF 13.8 million. I will start with the smaller numbers, which is actually CHF 0.4 million, corresponding to the 8% revenue sharing of the initial net sales with the launch of ponesimod by Johnson & Johnson into course of Q2. Another one, which is relating to the milestone paid by Mochida into first half in connection with the first subject first visit of the bridging study, phase III study in Japan for daridorexant. CHF 1.6 million was recognized from CHF 8.4 million paid.
All the rest, i.e., roughly slightly less than CHF 12 million, are deferred revenue from a previous collaboration that Idorsia entered into with J&J for aprocitentan, with Neurocrine for the calcium T-channel blocker, with Mochida, as just mentioned, for daridorexant co-marketing in Japan. We will come back to talk in a few minutes to the non-GAAP operating expenses, CHF 248 million, leading to a non-GAAP operating result of CHF 234. If you add the depreciation and amortization of CHF 8 million, the stock-based compensation of CHF 9 million, you end up at CHF 252, which is our U.S. GAAP operating results. Below the EBIT, you see here a positive number, CHF 8 million, mainly driven by a currency exchange gain on our deposit in U.S. dollars. Hence, we ended up with a U.S. GAAP net result of CHF 243 million. Next slide, 15, please. Here we provide a breakdown of the non-GAAP operating expenses.
As you can see on the right-hand side, CHF 248 million. Going up significantly, mainly in SG&A. Of course, if you're looking at this CHF 68 million, it breaks down between commercial with CHF 32 million, significantly up with the preparation of the upcoming launches. Also G&A going slightly up. Not only at the headquarters, but also in the affiliates. If I go from right to left, in order to launch, we also start to build inventory in drug substance, drug product, and finished product. We paid a milestone of CHF 5 million in connection with the filing of clazosentan in Japan. The development at CHF 115 million went also up, breaking down between clinical, CHF 74 million, and chemical and pharmaceutical department, CHF 42 million.
Another way to see it is actually CHF 46 million functional OpEx. The rest is really related to the clinical assets, with CHF 46 million study costs, CHF 14 million drug substance, CHF 10 million drug product. Research went slightly up with CHF 64 million. As you can see, and as explained by Jean-Paul, it's really all about properly preparing the upcoming launches in the region, U.S., Japan. Even if it has a much lower impact right now, EU file. Next slide, 16, please. Just to mention our cash flow. As you know, we started the year with CHF 1.2 billion liquidity. If you take into account the non-GAAP OpEx we just discussed, the CHF 8.4 million or JPY 1 billion paid by Mochida in connection with the initiation of the bridging study for daridorexant in Japan, CHF 17 million CapEx, CHF 16 million other outflows, mainly working capital requirements.
We end up with a liquidity of CHF 927 million by the end of June. Next slide, 17, please. Here you have a comparison of the liquidity with the start of the year and the closing of the first half. What is important also is to see how this liquidity is broken down between different currency. 681 in Swiss franc and 237 in U.S. dollars. These dollars are aimed to hedge our outflows in U.S. dollar with the upcoming launch of daridorexant in the U.S. It's a natural hedge, I would say. It's not a US GAAP accounting hedge, hence, and we were alluding to it, the fluctuation on the currency from one quarter to the other. Next slide, 18, please. Let me finish with the guidance for 2021.
As you've seen, we reduced the guidance by roughly CHF 20 million, with functional R&D at CHF 360 million, around CHF 10 million less than the previous guidance. Functional selling and G&A expenses at CHF 220 million, another CHF 10 million lower than initially guided. Still an inventory build of CHF 35 million, even if we had only CHF 6 million in the first half. No other milestone payments except the one already paid in Q1 2021. With this non-GAAP operating expenses, excluding, of course, unforeseen events, should be around CHF 620 million. If you add CHF 20 million D&A and CHF 25 million SBC, we would end up with the US GAAP operating expenses around CHF 665 million. With this, I hand over to Jean-Paul. Jean-Paul? You're on mute, Jean-Paul.
Sorry. Thank you, André. Next slide. Just this slide summarize the main milestones, which has happened and will happen in 2021 and next year. At the beginning of this year, we had, I repeat, the filing of daridorexant in the U.S., Europe, and Switzerland. We had the filing of clazosentan in Japan and the initiation of the SOS-AMI trial for selatogrel. In the coming months, we are going to get the phase III, the pivotal trial of lucerastat. And we are also going to have the result of the phase II-B, which can become a pivotal trial depending on the result of cenerimod. In the beginning of next year, we are going to launch daridorexant. We should get the approval and should launch clazosentan in Japan. In the middle of next year, we should have the result of aprocitentan in resistant hypertension.
At the end of next year, the results of clazosentan. That means we will have the results of all our phase III products at the end of next year. As you can see, the company, Idorsia, will become a very different company. Imagine that next year we should be a commercial organization with the launch of daridorexant. In addition, we will have launched clazosentan in Japan and maybe have positive results with lucerastat and clazosentan in Europe and the U.S. Next slide. That means really that our goal to become a profitable company is really approaching. I think it's not in the too distant future where we are going to be able to become financially independent, not only by having, of course, the ponesimod royalties, but also with our sales of daridorexant and with the sales of clazosentan in Japan.
I do believe that with daridorexant alone and clazosentan in Japan, taking into account our really strict cost control, we can become profitable with these two products alone. Of course, if lucerastat is positive and clazosentan in U.S. and Europe is also giving positive results, the organization that we are creating is going to be leveraged and of course our profit will grow. In the long term, of course, the revenues from aprocitentan and cenerimod and selatogrel will really complete this financial stream of revenues. I do believe that we have a very bright future, not only as a research and develepment organization, but as a commercial organization with multiple breakthrough and blockbuster products. Thank you. Next slide.
Thank you, Jean-Paul. This concludes our prepared remarks section for today. We have crossed the bottom half of the hour and now can shift over to the Q&A session where Simon Jose is going to be joining us to address them. Operator, please open the lines.
Thank you very much. We will now begin the question and answer session. If you have a question for our speakers, please dial zero and one on your telephone keypad now to enter the queue. Once your name has been announced, you can ask a question. If you find your question is answered before it is your turn to speak, you can dial zero and two to cancel your question. If you're using speaker equipment today, please lift a handset before making your selection. One moment please for the first question. The first question we've received is from James Gordon of JP Morgan. The line is now open, please go ahead.
Hello, James Gordon, JP Morgan. Thanks for taking the questions. A couple on the late-stage pipeline, please. First one was just about the readouts. I can see on slide 19 it looks like we're going to get lucerastat and then cenerimod. Is that right for the order or is that just illustrative and it could be either way around? That was the first question, please. Second question was about how you're thinking about chances of success for the two ones that are coming up. For cenerimod and lucerastat. I know cenerimod, maybe we could take some comfort from what we saw on the SLEDAI score in the prior study and the fact that you've got high dose steroids in both arms. Lupus has been quite a tough indication for sort of replicating datasets. How are you thinking about that?
The third and final question was just cenerimod, what's the range of outcomes, depending on what we see in terms of the timelines with which the product will come to market? I think I heard that the phase II-B could be pivotal. If the data's really good, does that mean it's potentially pivotal even as a study by itself? Or you'd still definitely need to replicate it and do another study. If you did that, would it be similar timelines to the first study? Maybe we'd be talking about like a 2025 approval or something like that. What is the range of outcomes depending what we see for cenerimod, please?
Yeah, James, thank you very much for those questions. I think we're all going to have Jean-Paul answer them. Number one, timing of lucerastat and cenerimod. Is our choice of depicting it on slide 19 any kind of indication? What is the success or the likelihood of each of the trials reading out, given the predecessor data? What is the range of outcomes of cenerimod? Jean-Paul, do you want to address those questions?
I think, just I have to say, it's planned, the reading of the results of cenerimod and lucerastat within a few days. It's falling like that. Sometimes, you can have one center not answering, so it can be a few one-week delay or two-week delay. It's basically, I cannot tell you which one will come first, but it will be very close. The two studies will be very close. We have more and more, of course, we will have more and more precisions when we are approaching. That will be within a few weeks, the two studies. The second question, if I may, Andrew, is about what are the chances of success? How we estimate the chance of success with cenerimod and lucerastat. Just for us, cenerimod, we made a first phase II-B. We now have done a very large study.
Of course, we want to know the right dose, but also the efficacy. I think that we know the safety because the DSMB has reviewed many times this data. I don't think there is really a safety problem which would prevent further use of this drug. I think that we are quite, the team, we are quite optimistic. You know that lupus is a tough disease, so we need to see the results. We had some very clear indication in the phase II-A, so that should be reproduced in the phase II-B. For lucerastat, as I have said, we have never tested the effect of the drug on neuropathic pain, which is the primary endpoint. On the other side, many patients are for more than two years within the clinical trial.
I do believe that if the DSMB, which is unblinded and knows if the drug has or no effect, I think that if the drug would do nothing, I think that since there are other treatments for Fabry, such as enzyme therapy or some Amicus drug, I think that they would have told us to stop the study. Of course, I don't know. I have no certainty. I think that the fact that this study is going on for now nearly three years is a very good indication. The third question is what do we mean for us of a positive study with cenerimod? I think it's very clear for us that for us, really what means positive is not only to get efficacy, but also to get a safety which is really acceptable at the dose which gives this effect.
We could see effects on maybe at only at doses which would not be acceptable. I think, as I have said, we have not been asked by the DSMB to, for example, stop the high dose. I think that the safety should be okay. It will be very difficult to compare our trial with other trials because this trial, our trial, has a very specific design for the corticosteroid use. As I've mentioned several times in the past, we have tried to optimize the corticosteroid use before randomization between placebo and the four doses of the drug in order to avoid interference of corticosteroid during the trial. This has not been done in, to my knowledge, in other large phase II-B or phase III, therefore, it will be very difficult to compare the results with what has been obtained.
Finally, can this study be alone sufficient for filing? I don't think so. What we have done is really to prolong the study to have also data after one year. This was at the request of the FDA, and this is in order to even better use the data of the phase II-B. I think that really, the FDA and other authorities will require another study confirmation. Of course, I believe that because we will have a very good definition and determination of the dose to be used, this study could be smaller in terms of size than the PRISM study.
We are preparing ourselves to be ready to initiate this last study as soon as possible and to interact with the regulatory authorities as soon as possible in order to get what we believe is maybe the best overall drug in lupus, which will come to the market. Let's wait for the results, and of course, we will know much more at this time.
Thank you, Jean-Paul. Thank you, James, for the questions. Operator, next question, please.
Yes, the next question is from Peter Verdult of Citi. Your line is now open. Please go ahead.
Thank you. Peter of Citi. Three questions, please. Firstly, just a clarification on cenerimod. If I look at clinicaltrials.gov saying primary endpoint in July. Just want to make sure that if the data are really coming in Q4, could it come any earlier? Secondly, for André, maybe if you just peek into 2022. We've got a growing and progressing pipeline. You're getting ready for the dari launch. That all requires funding. Just to make sure that we're thinking about this correctly, if I think about Citi and consensus right now, it feels that we probably need to be way over CHF 750 million in OpEx for next year, to reflect the dynamics across the pipeline and what you're doing from launch preparations.
I realize this is not the medium for guidance for 2022, can you just give us some pointers as to how we should be thinking about the R&D and marketing dynamics? Lastly, on Ponvory, I realize this is a J&J drug, but have you ever shared your perspective of the peak sales outlook for the asset? I'm only asking that in light of what is clearly a very competitive landscape and the fact that you don't have the fatigue data on the label. I just wondered, Jean-Paul, whether you could share your views as to what you think the peak sales opportunity of Ponvory is. Thank you.
Thank you, Peter. All right. On cenerimod , I think I quickly can address that. Yes, we do see Q4 as most likely, and that the clinicaltrials.gov probably needs yet to be updated. For André, the question on finances and 2022 outlook, a bit of granularity. Then Ponvory, Jean-Paul. André, do you want to take over the financial question?
Yeah, sure. Since we are in the middle of the Olympic Games in Japan, I will take an analogy here. It's with the hull race, one hull after the other. Yes, as you can imagine, we have a mid-range plan. That's also why Jean-Paul told you that we are confident with the upcoming launches, that we will reach sustainable profitability. No longer a question of if, it's more a question of when. Coming to the OpEx base for 2022, there are so many moving parts. Starting with the R&D, will we have costs relating to solanezumab with phase III following positive results of the phase II-B and some other moving parts in R&D. When it comes to marketing and selling, yes, sure. I would say it will continue to grow, especially when beginning of 2022, we will have the Syneos sales force in place in the U.S.
We will, with Q3, update you on the guidance for the year. Q4 would be a decent proxy, a part of the moving parts that I mentioned in R&D, with Syneos in the U.S. Globally, you can reasonably expect that the OpEx will grow in 2022. We need to have more certainty on the launch date for clazosentan. Things are progressing well in Japan. We also need to get a better understanding what could be the label in the U.S. Of course, the revenue will compensate for the growing OpEx base in 2022. Maybe I can take also the last one regarding J&J and Ponvory. We do not get any privileged information. I just recall from the demerger in connection with the J&J Actelion deal. This is a drug owned by Actelion, i.e., J&J, and to this extent, we are entitled to 8% revenue sharing.
Jean-Paul, maybe if you want to add your thoughts on Ponvory in CMS space.
I think that Ponvory, which has shown also superiority to Aubagio, which has published data on fatigue, maybe not on the label, but certainly on publication. I do trust that Johnson & Johnson is one of the best marketing companies. In fact, Johnson & Johnson is very well-known and renowned for its ability to market drugs. This drug has very clean and clear data. It's both in the U.S. and in Europe. It's also, I would say, one of the few n ew drugs that are now coming to the market for Johnson & Johnson. It's an area which is completely also open for Johnson & Johnson. I really trust, but I cannot give you numbers, but I really trust that Johnson & Johnson is going to make a success for Ponvory.
Thank you.
Thank you. Operator, next question, please.
The next question is from Rosie Turner of Barclays. Your line is now open. Please go ahead.
Hi. Good afternoon. Thank you very much for taking my questions. Just two, if I may. You've spoken quite a bit about how preparations are going with the U.S. sales force. That all sounds perfectly on track and great. Just wondering how it's going in terms of commercial preparations ex-U.S. Obviously, European approval of daridorexant will follow relatively shortly after the FDA approval, all things continuing on the current course. Wondering how that's going. Just on liquidity, obviously is getting a little bit tight in terms of the typical 18 months that the market looks at in terms of cash burn. Just wondering what your thoughts are there, what paths could be explored if you wanted to raise some additional capital going forward. Thank you.
Thank you, Rosie, for those questions. First one, launch preparations, U.S., non-U.S. Simon, I think that'd be one great for you to take. And then on the liquidity cash burn wage, André, please. Simon?
Yeah, sure. Thanks, Rosie, for the questions. I mean, ex-U.S., the preparation for daridorexant launch in Europe is going very well. As Jean-Paul said, we've established affiliates in the major markets. We've got general managers appointed in those markets, all of whom have got a lot of experience at dealing with the payer environment and opinion leaders there. The fundamental difference in Europe for us is that we will be the first and likely, I think, only DORA to enter the U.S. market. The dynamic is very different in that there has been no innovation for 20 years, and the excitement that we're seeing amongst the specialists and the opinion leader community is actually quite palpable because they have all the same concerns and worries over the use of Z-drugs and benzos that we see in the U.S., but they've yet to get their experience or hands on DORA.
There's a lot of excitement and we're working very closely with opinion leaders as we start to develop our strategy. That's all on track. Obviously, it's a few months behind the U.S., just naturally because of the regulatory timeline, and certainly in Europe, there'll be, as you're well aware, some access work to be done in countries like France and Spain. Italy is interesting because Italy, the insomnia market is self-pay, so we can get into Italy earlier than we might otherwise go in because we don't have to go through the reimbursement process. Turning to Japan and to the preparation for the Clazo launch. That's all on track as well. We've got the medical team stood up. We've got MSLs in the field. We're engaging with specialists. A high degree of excitement there. Similarly, this is a very prevalent condition there.
It's more than twice the incidence that we see in the rest of the world. They're acutely aware that they have a very high incidence of vasospasm and SAH. I think there's a lot of excitement in the medical community there because, again, similarly, they've had no innovation for, I think, for fasudil was 1995, and the evidence of the efficacy of that isn't brilliant. I think, again, I think we're on track there and see nothing pending approval to see a successful launch in Q2 of next year.
Thank you, Simon. André, liquidity?
Yeah. Liquidity. I think I made it very clear over the previous calls that we're not funded to break even, and that we do not also want to be against the wall. That's why we would like to have liquidity or cash covering our next 12 months cash burn, at least. As you know, we are also exploring all avenues, the classical one, equity or equity-linked capital market on top of the J&J credit facility, which we can draw down at any time. CHF 243 million, just to mention. Maybe some also other routes, like royalty monetization deals. That's the advantage of having many assets that could be eligible to such deals. At the right terms. This means also at the right timing.
You would get much more value if the regulatory risk is off the table with drug approved or on the verge to be approved following positive readout of pivotal trials. Of course, we have also the out-licensing route, where we could try to upfront some cash in this type of deals. We have a variety of instruments available to us. We remain vigilant to be able to seize any opportunity if one would be attractive to us.
Perfect. Thank you very much.
Thank you, André. Thank you, Rosie. Operator, next question, please.
The next question is from Graig Suvannavejh of Goldman Sachs. Your line is now open. Please go ahead.
Hey. Good morning, good afternoon. Thank you for taking my questions. I've got three if I could. My first is on daridorexant, and particularly the European opportunity. While I understand perhaps the opportunity to be the first DORA on the market in Europe, my impression is one where perhaps the reason why others haven't been able to go there just yet is just reimbursement pricing and the market opportunity. Could you provide just your high-level comments on how we should think about the European revenue opportunity relative to the U.S. opportunity, at least in your opinion? My second question just has to do with cenerimod and comments around what's next, assuming positive data in the Q4.
I've seen some pivotal phase III programs in this indication being sometimes as many as 1,000 patients, and I'm just wondering how, and while I know it's early days, but if you could provide any high-level thoughts on how you're thinking of what that perhaps phase III program might look like and whether it is just one study and if you would need to have a relatively sizable patient population in that phase III study. Perhaps my last question. Well, maybe I'll let you answer those two first, and then I'll ask my third. Thank you.
Okay. Thank you, Graig. On the daridorexant question, I would actually like to split it in two. Have Simon Jose address the opportunity and then shift over to Jean-Paul for the patient need part of it, as we do feel very somewhat puzzled sometimes about how European patients are being treated. And then Cenerimod, can Jean-Paul repeat your comments as before on the phase III program? Simon?
Sure. Yes, Andrew. Thanks, Graig, for the question. I think those two points are linked because part of the reason we see such a big opportunity is the unmet need in Europe is just as high as it is in the U.S. It is a generic market. You're absolutely right, that means we end up with payer scrutiny. The generic drugs that these people are dealing with have adverse events. They've got addictive properties. The regulators are really concerned about their use. In fact, most of the labels of the sleep drugs in Europe limit their use to two or four weeks. In countries like Germany, they won't reimburse beyond four weeks. They're having such a challenge with existing treatments.
I think if we have the right conversation with the payers and we're talking about the right patient population, as you know, with the right sort of price point, then I think that the unmet need will allow us to establish a good position in Europe. What exactly that will look like from the revenue point of view is clearly too early to say. I think if we were entering a generic market where the generics were good and well-established and people didn't have concerns, which is often the case in diabetes and other areas, then fair enough. There is such consternation and concern about the current makeup of the market and that we believe with the opinion leader backing that we're seeing, that we do believe that these are challenges that are overcomeable.
Great, Simon.
Maybe I can add to Simon. I think if you take France, you cannot take Z-drugs for more than eight days. People forget that we are doing studies with our drugs over a year. There is no chronic drug. There is no one single chronic drug approved in Europe for more than a few days. We are going to get a unique opportunity. I think that we should be very careful when we compare daridorexant to other long-acting, I would say, orexin receptor antagonists. The problems of the precedent orexin receptor antagonists were the long half-life leading to somnolence in the morning and s ide effects, which in the U.S. have been solved by decreasing the dose, leading to much lower efficacy. I think that we should really not forget that daridorexant is sort of optimized orexin receptor antagonist.
Also, when you think of the market and you think of Europe, we don't need to get 100% of the market. I would say 15%-20% of the market will be already leading to blockbuster numbers. This is true in the U.S., this is true in Europe. We don't need to be a 70% market share to be very successful, and that is the beauty of insomnia market. I do believe that we will grow with daridorexant for the next 14 years of market exclusivity that we have, because we will never be able to treat all the patients we should be treated with a drug like daridorexant.
Maybe I can take over cenerimod question as a group.
Yep, go ahead. Follow on.
The cenerimod. We have discussed very carefully with the FDA. We have really followed all their advice in order to be completely in line with them, because we know that especially this division is very keen on safety. They know that the lupus patients are sometimes and this is why we have done a huge, it's one of the biggest, maybe the biggest phase II-B ever done in lupus. We have more than 400 patients treated in this study for phase II. We are also following the patients for a year. That was agreed with the FDA to be potentially used as the first pivotal trial. Of course, depending on the results. I think that in order to be able to use it as a pivotal trial, we need to have a clear-cut efficacy and safety, of course.
If this study, which we believe most likely will be positive and really give us the right dose, I think we will be able to have a study only performed with the dose with the same endpoint that we have chosen in phase II. I think this study will require much less than 1,000 patients, as you have mentioned. This study also will be much easier to recruit in terms of patients because we will then choose a drug for this phase III, which will have a very well-known and described safety and efficacy.
Thank you, Jean-Paul. Graig, you had a follow-on?
Yeah, I did. Just on the MS market. I'm just wondering the ideal positioning of your product. There's growing emergence of the anti-CD20s. I'm just trying to figure out if you have a sense of what the ideal or the target patient population is for the product. Thanks.
Jean-Paul, do you want to address that?
As I said, for the MS drug. Which MS drug you mean? For ponesimod?
For ponesimod, yeah. How does its uniqueness with its PK/PD profile, rapid onset, rapid off, translate into patient utility? Who is most going to benefit from that?
It's clearly an oral drug, so it doesn't need injection, number one. I think that the efficacy and I think that the side effect profile has been well-characterized in comparison with another very well-established oral drug, which is Aubagio. I think that we have many long-term data also, which are quite unique because I think that the patients have been followed for eight years. This drug is extremely well-tolerated. I think there are many arguments to sell such a drug. You also know that this is very fastly reversible. You can see in terms of, in times of COVID or viral infections, I think it's a very, very big advantage to have a drug where you can stop treating the patients and two or three days or maybe a week after, the patient has a normal immune system or close to normal immune system.
Of course, if you use a long-acting CD20, you are going to be months at risk of this viral infection or other type of nosocomial risk of infection. I think that there are many arguments and there is a very, very good market position for a drug like ponesimod, which is in my mind an optimized S1P1. Which also doesn't need, compared to fingolimod, the same scrutiny for the cardiovascular effect during the first days of treatment, and which is a much cleaner, I would say, side effect profile in my mind. Let's see how Johnson & Johnson can do and can perform.
Okay.
Thank you, Jean-Paul. Thank you, Graig, for the questions. Operator, mindful of time, are there any questions left in the queue?
Yes. We have one last question. It is from Thibault Boutherin of Morgan Stanley. Your line is open.
Hello, can you hear me?
Yes, we can.
Okay. Thank you very much for taking my question. My first question is on the U.S. internal market and the DORA in particular. Since the launch of Dayvigo, Eisai has been able to grow that market by about 40% in volume. They have taken around 25% share. They've done relatively well. Just wanted to add your comments on how you see the evolution of this market. In particular in the context of COVID. By the time you launch daridorexant, probably the competition will have improved a little bit. Just wanted to have your thoughts on the current dynamics and what's playing out right now between Merck and Eisai. Maybe just a quick question on venglustat. Just wanted to know the context of the discontinuation of the natural history study in lysosomal storage disorder and how your thoughts are changing regarding this early stage asset.
Okay, Thibault, thank you for your questions. Simon, can you address the U.S. DORA dynamics and how you see Dayvigo and our launch process moving forward? Jean-Paul, if you could address the venglustat, if we can.
I'm assuming that the comments about the 25% and the 40% sort of growth is maybe looking at that in the context of the DORA subclass, if you will.
Yeah. Sorry. In regards to it, yeah.
Clearly the dual orexin market itself is small. I mean, suvorexant has got about a 1% market share. If you look at the uptake so far of lemborexant, I think one year in, they probably are about 1/3 of what suvorexant was at the same time point. It's clearly struggling, we would say, and essentially that it's not helped really expand the DORA class. That goes back to Jean-Paul's earlier comments about the PK profile of both assets in that they have long half-lives. That is either going to create an adverse event challenge and somnolence in the morning, or you drop the dose and then you have an efficacy problem, which is what we've seen in the marketplace. We clearly have a very different profile and expect therefore to be in a very different position.
In terms of COVID, I think there's two ways of answering that question, I guess. One is we've clearly seen an increase in the prevalence of insomnia during COVID times. I think if anything, COVID has brought insomnia and its prevalence into the forefront, which is no bad thing when you're about to enter that market. In terms of our own launch preparation, I think we're in a very good position because we're obviously building our commercial organization and our commercial model from scratch. We don't have to repurpose an existing organization that was built for the old world, and we're certainly very attentive to all the digital channels that Jean-Paul has mentioned.
The use of big data, doing things differently, and we're certainly looking to build a commercial organization that is modern and fit for the future and fit for a world where we've seen the world frankly transform into a much more digital place in a very, very short space of time.
For venglustat, I take the question, Andrew?
Yes, please.
I think for venglustat, we are really just a few months close to the lucerastat. lucerastat is a very good drug, and I think if the study is positive, it will be unique. Frankly, we are a little bit hesitating. Can we expand, for example, the label indications in future studies with lucerastat? Should we really start with venglustat, which is more powerful, which has some advantages, but which is still within the same type of drug, number one? Number two, you have seen some negative studies with the Sanofi drug. We need really to analyze a little bit the differences between venglustat and, for example, the drugs of Sanofi, really in order to really take some lessons from the negative results of Sanofi.
Finally, I have to say that we have some drugs coming to end of phase I, early phase II, which have fantastic potential. We are very careful on our costs. I would like to say that when people think that the clinical development costs will continue to grow, they are wrong. We really want to limit our clinical development costs in order to be also able to invest into our launches. Most of our phase III are finishing, and I think that we, as I mentioned, next year, aprocitentan, clazosentan, daridorexant, of course, but also lucerastat will be finished. Basically, the two phase III products will be cenerimod in a quite limited, I don't believe in a huge study, but it will be cenerimod and selatogrel, so two phase III products.
We are very careful before starting phase II or phase III with any other products in order to have a very, very strict cost control. We only want to initiate phase II and phase III with drugs where we are confident that not only they have a big chance of clinical success, but also they have a very large market potential.
Thank you, Jean-Paul. Thank you, Thibault. Okay. I think we've exhausted our time. Operator, we don't have any further questions, I'm assuming.
No, there aren't any further questions.
I think we've come to the end of today's call. Thank you very much for your ongoing interest in Idorsia. I am personally looking very forward into an engaging second half of 2020 and 2021, where we prepare ourselves for market launch, move clinical assets forward, we analyze data, and we live up to our expectation and aspiration to become one of Europe's leading fully fledged biopharmaceutical companies. Operator, please close down the lines.
Thank you. Ladies and gentlemen, thank you for your attendance. This call has been concluded. You may disconnect.