Good afternoon or good morning to you all from where you're dialing in. My name is Andrew Weiss. I want to welcome you all to our full year financial results publication call today. Today, we're going to talk about our financial performance and update you on the progress we've made in 2019, as well as give you an outlook for 2020. With me on the call are our CEO, Jean-Paul Clozel, and our CFO, André Muller. They're here to give you additional color on the results published this morning at 7:00 A.M., together with the annual report. Please note that we are experiencing a slight technical trouble. I ask you all to download the presentations from our website at this point in time, as they will not be able to be scrolled forward. Next slide.
Before handing over the mic, I need to remind everyone that we will be making forward-looking statements. You've therefore been adequately warned about the risks and opportunities of investing in Idorsia shares. With that, I hand over to Jean-Paul for his introductory remarks.
Thank you, Andrew. Good morning or good afternoon to everyone. It's a pleasure to present to you the progress we have made at Idorsia during 2019 and highlight a few of the exciting developments we expect in 2020. Let's first look at the achievement of 2019. To begin with, we have added two innovative compounds to our pipeline from our drug discovery team. We have advanced each of our clinical programs. We are expecting the first phase III results in the next few months. We have been sharing our work through scientific publication and at congresses. We have been able to engage with experts in our different fields. We began building our commercial capabilities and planning the launch of our first products. Let's discuss these points in a little more detail. Slide five, clinical development pipeline.
Here you can see our clinical development pipeline of 12 assets. From top to bottom: late-stage, mid-stage, and early assets. We are very proud of this pipeline because all of our products are extremely innovative and address a large medical need. Slide six. Let's look at our late-stage assets first. We're expecting the results of the first of the two pivotal studies with daridorexant in insomnia in the next few months, and the second pivotal study will follow closely behind. Both studies are fully recruited today. Slide seven. The speed at which we have been able to advance daridorexant is very impressive, particularly when you remember that we created Idorsia right in the middle of this program. What potentially differentiate daridorexant from existing treatment is the delivery of clinically meaningful benefits in sleep onset and maintenance without exceeding a normal night.
Patients with insomnia face multiple challenges, including both falling asleep and staying asleep. They are actively seeking new safe and effective treatment options which can address both these needs, ultimately helping them to function better during the day. By blocking the action of orexin, we hope that daridorexant will allow patients to sleep throughout the night while avoiding the rebound, withdrawal, or tolerance problems associated with many sleep medications that act through broad sedation of the brain. We really are only a matter of months from the first set of data. Watch this space. Slide eight. Later in 2020, we also expect to have the result of the Japanese registration study with clazosentan, a selective ETA receptor antagonist being developed for cerebral vasospasm after subarachnoid hemorrhage.
This is a significant problem in Japan, where the prevalence of subarachnoid hemorrhage is around twice as high as in the rest of the world. clazosentan could really make a big difference for these patients who seem to make a good recovery from the hemorrhage, only for the vasospasm to cause devastating effect. The global phase III outside of Japan for prevention of clinical deterioration due to vasospasm is progressing well, with results expected around a year after the Japanese data. Slide nine. We are also making progress with the development of lucerastat, an oral therapy offering a new treatment approach for all patients with Fabry disease, irrespective of mutation type. lucerastat acts by reducing the damaging buildup of lipids, which is responsible for all the symptoms of Fabry disease. It can penetrate tissues and the central and peripheral nervous system.
This is the reason we believe that lucerastat can reduce this lipid buildup and therefore reduce neuropathic pain, which is the endpoint which we have chosen in MODIFY. The recruitment has been slower than originally anticipated, and the results now are expecting in 2021. Slide 10. Our first phase III program involves aprocitentan, an overly active dual endothelin receptor antagonist, investigated in the PRECISION trial for patients whose blood pressure is uncontrolled despite the use of at least three antihypertensive drugs. Because some of the patients, which had to be included in the study, were planned to be in China, we are compensating for the problem of China, of course, related to the coronavirus, by increasing the number of sites to compensate and to be able to have the results of aprocitentan studies at the end of next year or beginning of 2022. Slide 11.
As our late-stage assets progress, the mid-stage assets come more into focus. Slide 12. cenerimod, our selective S1P1 receptor modulator, is being investigated for the treatment of lupus in a multiple dose efficacy and safety study, which could become a pivotal trial depending on the results. The study was initiated in early 2019. So far we are making good progress with the recruitment. We may get the result of this study by the end of 2020 or early 2022. We have been very encouraged by the result of the first study in patients. Therefore, we are getting ready to initiate the second pivotal study as soon as the current study is concluded. Slide 13. This year, we also share the results from phase II study. The result, in particular, the result of selatogrel, our highly selective P2Y12 receptor antagonist.
We have shown that selatogrel demonstrates a very rapid onset of action with the effect lasting between four to eight hours after subcutaneous administration in patients suffering a heart attack. With this efficacy together with the observed safety and tolerability profile, we believe that selatogrel should be self-administered at the onset of symptom to stop a suspected heart attack and preserve cardiac muscles and heart function. An incredibly innovative approach to a very serious problem. The key aspect of this approach was to find a safe and reliable device, easy to use under stressful conditions. Last November, we were very pleased to sign a deal with Antares Pharma to develop a novel drug device product combining selatogrel with a subcutaneous QuickShot Auto Injector. We are now running usability and reliability studies, and in parallel, we are negotiating an SPA for a large phase III study with the FDA.
We plan to initiate phase III in the first half of 2021. Slide 14, early-stage assets. As I said, we have added two very innovative new compounds to the clinical pipeline, and this shows the productivity of our drug discovery engine. We have negotiated with Neurocrine an option deal for T-type calcium channel blocker. The FDA will give their feedback for the IND of this product by mid this year, Neurocrine will have to decide to exercise this option. Our strategy remains in drug discovery to balance novel projects, testing new mechanism of action with the projects which are aiming to optimize drugs with an established mechanism of action. We aim to be the first in class or best in class. Slide 15. In 2019, we put considerable effort into sharing our data with experts in the different fields that we are active in.
We have been able to share the results of several of our program, daridorexant in insomnia, aprocitentan in uncontrolled hypertension, selatogrel in heart attack, cenerimod in lupus, with experts at the most prestigious medical conferences, reaching more than 60,000 key experts. We are also very excited to see our partner, Johnson & Johnson, reporting data from a successful phase III trial on ponesimod for the treatment of relapsing multiple sclerosis at ECTRIMS 2019. This was particularly rewarding because not only are the scientists who discovered ponesimod now with Idorsia, but also our revenue sharing agreement with J&J means that the quarterly payments of 8% of the net sales of ponesimod are likely to be our first source of regular income. J&J has announced in their annual call two weeks ago that they intend to file ponesimod this year.
The last point, slide 16, that I want to highlight is the effort that our Chief Commercial Officer, Simon Jose, is putting into preparing for success. This year, he has been establishing his core commercial team and defining detailed commercial strategy for key late-stage compounds. He has been able to fill several critical roles, most recently appointing Patricia Torr as President of our U.S. commercial organization. As CEO of Idorsia, I'm very proud that we have been able to attract some top talents and seasoned industry leaders. With that, I would now like to hand over to André, who will take you through the financial results of 2019.
Thank you, Jean-Paul. Good afternoon or good morning to everyone. Let's go to slide 17. As you see here, we see CHF 470 million non-GAAP OpEx. We spent less in 2019 than originally expected. Just to recall, we guided with the Q3 results that we would spend slightly less than CHF 500 million. Going to the next slide, 18. Let's have a look at how the U.S. GAAP net results came about. On the left side, you see the revenues, CHF 24 million. This includes CHF 5 million from the R&D collaboration with Roche and the revenue recognition of CHF 19 million regarding aprocitentan for the development collaboration with Janssen.
I said, and I will come later on this, non-GAAP operating expenses amounted to CHF 470 million. We have a non-GAAP operating result of CHF 446 million. Including CHF 20 million G&A, CHF 17 million stock-based compensation, we have U.S. GAAP operating results of CHF 482 million. Below EBIT, you have little non-GAAP or cash expenses. Roughly CHF 2 million, mainly interest expense in the negative interest rate environment and a small capital tax.
Other rates, roughly CHF 10 million, is really non-cash expenses, mainly CHF 8 million with the accretion expense, CHF 8 million with deferred tax, CHF 4 million relating to the Swiss tax reform, CHF 4 million relating to the stock-based compensation. We had a gain of CHF 6 million, which is actually the market to market on the Santhera shares that we received in connection with the DMD compound, vamorolone. Let's go now to slide 19, the non-GAAP operating expenses. Here you have the comparison between 2018, CHF 399 and 2019, CHF 470 million. As you can see, drug discovery is stable at CHF 115 million. These are for 90% functional OPEX, i.e., fixed cost. You see the increase mainly coming from the development, going from CHF 215 to CHF 297.
If you break down this CHF 297, you see roughly that we have functional OpEx around CHF 70 million, i.e., fixed cost base for clinical and pharmaceutical development. All the rest is really variable cost, including CHF 160 million study cost. This increased by almost CHF 50 million compared to 2018. A significant portion, CHF 61 million, relating to drug substance and drug product that we actually need in order to be able to investigate our various compounds into a clinical stage. This one also increased by roughly CHF 10 million.
SG&A was more or less stable, CHF 58 versus CHF 54. Actually, the CHF 58 includes CHF 10 million relating to commercial, where it was close to zero in 2018. Meaning also that the real G&A part was going down as we managed also to get out of all the transitional service agreements that we had from the merger with Actelion.
Last year, just to recall, that we paid a milestone in connection with vamorolone, the DMD compound of CHF 15 million. If we switch to the next slide 20, regarding cash flow. Left side, you see the milestone received this year. It's the CHF 5 million upfront paid by Neurocrine with respect to the T-type calcium channel blocker that Jean-Paul just mentioned, compared to last year, where we got the CHF 35 million with Roche, with R&D collaboration, CHF 15 million, and CHF 20 million, in connection with the sub-license of the DMD compound to Santhera. The funds from operation CHF 473 or CHF 402 from last year are directly in line with the non-GAAP OpEx that I just mentioned. Difference is really minor, around CHF 3 million, relating, as said previously, to see financial expenses and some minor capital tax.
Last year, you may recall that in July 2018, we raised CHF 505 million, CHF 305 in equity, straight equity, and CHF 200 million in convertible bonds. This year, we did not tap equity or equity-linked capital markets. The CapEx is around CHF 19 million compared to CHF 17 last year. It's mainly maintenance CapEx, except CHF 5 million this year for a small manufacturing unit that we invested in order to be able to supply in a timely manner the clinical batches that we would need for some of the late-stage assets. The other is mainly relating to working capital requirements.
Let's go to slide 21, liquidity. Just wanted to go back from the demerger on June 16th, 2017. As you know, we demerged from Actelion with CHF 1 billion cash, CHF 420 million, which was cash spun out of Actelion, and CHF 580 million with the convertible bond held by Johnson & Johnson.
The six and a half months of 2017, we had a CHF 91 million inflow, which was mainly relating to the appro deal with Janssen and the upfront of CHF 230 million milestone. We discussed already the CHF 129 in 2018, the minus CHF 481 in 2019. We end up the year 2019, with CHF 739 million cash or liquidity. It means that we are well-funded. To be very clear, we are not funded to break even. I would conclude with the next slide with the guidance, which will be around $500 million non-GAAP OpEx or $540 million U.S. GAAP, including stock-based compensation and D&A. As I often said, again, with the CHF 740 million, we are well-funded with more than a one-year cash versus the next 12 months cash burn that we anticipate for 2020. With this, I hand over to Jean-Paul for his concluding remarks.
Thank you, André. As you have heard, Idorsia has achieved a lot in 2019. Our pipeline has dramatically progressed, and soon we are going to obtain our first phase III results. For a company which is only two and a half years old, this is unique. The success of the launch of daridorexant will be key for the future of Idorsia. In 2020, we will all do our utmost to be ready for this challenge. Now I hand over to Andrew to open the floor for questions.
Thank you, Jean-Paul. We have come to the end of our prepared remarks, and I'm now ready to take your questions. Operator, please populate the roster.
Thank you very much. We will now begin our Q&A session. If you have a question for our speakers, please dial zero 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 two to cancel your question. If you're using speaker equipment today, please lift the handset before making your selection. One moment, please, for the first question. We've received the first question. It is from Richard Parkes of Deutsche Bank. Please go ahead. Your line is now open.
Hi. Thanks very much for taking my questions. Just start with a couple. Firstly, I just wondered if you could talk about your optimism over potential labeling of daridorexant, and how that's impacted by the approval of suvorexant. It felt like your competition seemed very confident about getting an attractive label, it doesn't seem to have worked out that way. I'm just wondering to what degree you think the FDA will treat some of the side effects like sleep paralysis, cataplexy, and impact on next day function as class effects versus allowing you a cleaner label. That's the first one. Second one, just wondered if you could talk a little bit about your current thoughts on commercialization strategy for daridorexant. Just wondering to what degree the Mochida deal in Japan is a guide of what we should expect for global collaborations. Thanks for taking my questions.
Okay. Let me answer about your labeling questions. First of all, in the label, I think that even as a company, I think that they are mentioned in the labels, and I don't think that driving, you can say, "Drive, take your drug, and drive afterwards rightly just afterwards." I think there is also a question of liability, and I would not like not to mention any issue or any potential issue with driving. There are things where I think that the FDA, whatever we will see in our studies, will have tendency to be very cautious. We have also made a lot of efforts in collaboration with the FDA, and I tell you that the FDA is very eager to see our results. For example, to test our drug in patients and very high dose our drug in patients with respiratory problems, in elderly.
We have tried to look at all potential drug interactions, and you have seen that a lot of the studies have not been included with daridorexant are still in the post-commercial commitment. Also, the last thing to mention is the fact that we have tested in phase III, three doses. Therefore, we are going to be really able to take the dose, which gives the best compromise in efficacy and safety. For all the other products, basically one dose or two doses maximum, but were tested into phase III, and there was not any of this flexibility. I think that we have done a very large program, and I think that the FDA is going to reward us, I'm quite convinced, by helping us to find the best dose and have the most adequate label. Now, for the commercial strategy, Mochida was very clear.
It was very clear in Japan that we needed a partner. Japan is a country which requires a lot of medical representatives to see the doctors. There was no way that we could sell a drug on our own in Japan. In the other countries, the only thing I can tell you, and I will not go into the detail of the strategy, is that we want to keep the control. Meaning to have the regulatory responsibility, the drug safety, pharmacovigilance, the production responsibility, and also the medical marketing role to choose the next studies that we should do and how we should profile this drug. The rest is quite open. There are many possibilities. We can have our medical representative from a clinical sales organization. We can rent this contract.
Sorry, contract sales organization. As soon as we get the results, we will go in more detail with you on our strategy to successfully launch this drug.
Thank you.
Thank you, Richard. Operator, next question, please.
The next question is from Ram Selvaraju of H.C. Wainwright & Co. Your line is now open. Please go ahead.
Good afternoon. This is Edward [White], on for Ram. I appreciate you guys taking the questions. We noticed recently that the INSPIRE-CKD study was withdrawn from clinicaltrials.gov, and I know you mentioned it in your shareholder letter as well. Just wondering if that study is still on track to start this quarter, and if not, do you have any updated timelines for ever starting that study?
Yeah. Hi, Edward. We are not going to be pursuing forward with the INSPIRE-CKD study. What we're going to be doing is that the efforts that have been put in starting off that file are going to be basically merged into the PRECISION trial, such that all the sites that have been put up to run are going to be put into the PRECISION. We've been seeing a number of patients suffering of kidney disorders in the PRECISION trial, and therefore, we think that that's appropriate way to address it.
Okay, that makes sense. Just a quick one on cenerimod. I'm wondering when completion of enrollment in the ongoing trial in active SLE is anticipated.
Could you repeat the question, please?
Enrollment.
Yeah, sorry. When is completion of enrollment in the ongoing cenerimod active SLE trial anticipated?
Yeah, I think it should be finished end of this year. We are planning to finish the enrollment end of this year. It's a six-month trial, results will be available next year.
Got it. Finally, you had the recent amendment to the ACT-541468 licensing agreement. I was just wondering if, considering all of the early-stage assets that you have, are you in further licensing discussions for any of the additional phase I assets? Are any of them garnering particular interest among licensees? Do you anticipate just self-commercializing most of them?
I think there is a big gap between the phase I and commercialization. I think that what we have observed.
You can see with the last deals of Novartis, the company is ready to pay CHF 9 billion, while the same asset was CHF 1 billion or CHF 2 billion a few months ago, that more and more big companies don't like to take risks. Therefore, the value is exponential with time because people are eager to really have late-stage assets. Therefore, most of the time, I think we are going to at least initiate the early-stage development, which is not the most expensive, but phase I, phase II. When you have proof of efficacy, when you have an idea of the dose and the safety, I think that these assets are a much higher value. That is going to be our strategy. Certainly, we are not going to really want to develop and commercialize all these products on our own.
Thank you very much.
Thank you, Edward. Operator, next question, please.
Thank you. The next question is from Graig Suvannavejh of Goldman Sachs. Please go ahead. The line is now open.
Thank you, and good morning, good afternoon. I've got three questions. If I could, my first question has to do with total OpEx for 2020, and I'm wondering if you could give us a little bit more color around the ramp of R&D and SG&A and how we should think about that relative to what you reported for fiscal year 2019. That would be helpful. That would be my first question. My second question has to do with, if you could provide just a little bit more granularity around what you're hoping to see in the phase III studies for daridorexant. Any particular outcome measure in terms of sleep latency or onset in terms of specific numbers and of the magnitude of effect you're hoping to see and how that might differentiate versus the existing dual orexin receptor antagonist. That would be great.
Lastly, if we could just talk about how you're looking at 2020 and your capital needs. Clearly, you're well-funded right now, but as we look to 2021, which I assume will be another relatively intense year in terms of capital needed, just how you're thinking about your different options for 2020. Thanks again, and congrats on the progress.
Jean-Paul, you want to take the first question?
Yes, sure. Just to give you a little more color regarding the CHF 500 million that we indicated for 2020. These, of course, include positive readouts for daridorexant and for clazosentan in Japan. We would need to gear up in both countries because we do not have any commercial organization except the very small team that Simon managed to set up here at headquarters. You've seen the appointment of Patty Torr, will join us beginning of March. There's a lot in both countries to prepare for the, hopefully, launches of daridorexant and then clazosentan. Of course, this will be a contingent to a positive readout, mainly for daridorexant, but also for clazosentan. There's a slight increase, CHF 470 to CHF 500. That's mainly driven by the additional commercial expenses. We need also some slightly more G&A because we need also to set up an affiliate in the U.S.
For the rest, I would say, globally, R&D would be in the same range as the numbers that you've seen for the actuals in 2019. For daridorexant, I think you are asking a very good question, because expectations are very important. I think that what we have struggled, and we made more than 30,000 products really to select this compound. Why was it so difficult? It was so difficult because we wanted the ideal pharmacokinetic. You might have seen, if you look at a little bit at the label of lemborexant and suvorexant, you see a lot of effect during the day, the following day after administration of the drug. You see somnolence, you see side effects, which are due to the very long half-life, and in case of lemborexant, the presence of an active metabolite.
An active metabolite is about the worst that you can expect from such a drug because you don't know how long it's going to work and how different from what patient with another is going to be. You have this continuation of the effect, and therefore, in order to avoid the side effects, the companies which have developed these drugs needed to reduce the dose, and I think reduce the potential efficacy of the drug in order to avoid the side effects. The first thing we should look at our drug is simply efficacy. How fast can it work? How long can it work? What is the effect on the pure sleep parameters? That's going to be efficacy for me is going to be number one. Let's look at it. Let's compare to the other orexin compounds.
Let's compare to the other drugs on the market, number one. Number two is safety side effects. How many patients, and we are testing three doses, so we choose one dose or one or two doses. Let's look at what are the side effects. Can the three doses be given without too much side effects? Only two doses? We will see with the result. Somnolence the next day, next-day performance, all these drug interactions, all these effects which are related to the pharmacokinetic of the drug, you have to look at. Finally, I would not believe that we can look at efficacy, but maybe we have no negative effect, is the next-day performance. Because we have agreed on a PRO with the FDA to evaluate at the end of the next day after taking our drug, to ask the patients how did they function during the day.
This has been a two or three years effort to develop a PRO specific for sleep, agreed with the FDA. Of course, we are going to see what are the effect of improving sleep on the next-day performance. This will be the first. I can tell you the FDA is looking forward because nobody has ever been able to evaluate this type of effect. In other words, we have three doses, and we are going to have to choose the best compromise between the efficacy, not only on sleep, but on the next-day performance. That's going to help us really to choose the best dose of the drug in these patients.
Thank you. Just follow up on the financing or liquidity for 2020.
Please, André.
Well, you're right. As Jean-Paul said, we're not funded to break even. I also said that we have different avenues to bridge this funding gap. Of course, the most classical one is the equity capital markets. Here, we will remain opportunistic. We have the possibility to draw down the JNJ credit facility. It's now CHF 243 million. As you've seen, Jean-Paul went through the pipeline. We have a lot of fully uncovered clinical assets that could be partnered. It takes time. We need also to find the right partner. Also, as Jean-Paul said, we need also to get the right value for such assets in such collaborations. These are the different ways to finance. At one stage, yes, we'll need to action one or the other or several of these avenues.
Okay, thank you very much, and we look forward to the phase III data for daridorexant. Thank you.
Thank you, Graig. We too.
We also.
Operator, are there further questions?
Yes, there's one further question. It is from Emmanuel Papadakis of Barclays. Please go ahead. Your line is now open.
Thanks for taking the question. Emmanuel Papadakis from Barclays. Just a few follow-ups, actually. André, you said at some point you will need to consider additional sources of capital. Could you just confirm that will very likely be within this calendar year? It would seem you'll have to make some decisions before the end of the year, at least. Follow-up on daridorexant. It sounds like both the headline efficacy, but also the tolerability or overhang effects are going to be key metrics we should be looking at. Somnolence was a relatively actually modest incidence in both the suvorexant and lemborexant study, something like mid-single digit. Do you expect to come in lower than that? If so, do you think that is going to serve as a meaningful point of differentiation in clinical practice in terms of driving uptake of the drug? Just one on the aprocitentan.
The rationale for discontinuing the CKD, does that reflect a lack of medical interest, difficulty with patient recruitment? If you can just comment on the timing of PRECISION. clinicaltrials.gov has early 2021. You're clearly pointing towards the end of 2021. Is that just an inaccuracy on the website? Are there any reasons why we might actually get the data sooner? Thanks very much.
Okay. André, do you want to take the source of capital question?
Yes. On a personal note, welcome back, Emmanuel. Thanks for communication of the coverage. I read it thoroughly. Some disagreement on the sales expectations, but we'll have ample of time to discuss this once we have the launch of the drugs. Well, I would not commit to a deadline. Should it be before the end of the year, it will depend on the various sources of cash that we could raise. It might be a combination of the different avenues.
I would not put a deadline by end of December this year. What is sure, because we do not want to be against the wall, i.e., also having to partner some of the assets in worse conditions. We really want to have liquidity or cash at least for the next 12 months cash burn. You can do the math. This is the easiest part, and it will depend on the different sources of financing. Come back. Thank you to give me the opportunity to really precise what I was meaning. When we say there is a low incidence in the label for somnolence, if we consider that 7% at five milligram of somnolence and 10% at 10 milligram is low, then I agree. For my side, I consider it as very high, and I really hope that we don't have this type of percentage.
I really hope so. At least for me, it's unacceptable. I think this is completely related to the pharmacokinetic or the active metabolite. Nobody knows what is the role played by this active metabolite of lemborexant into this effect. I think this is one of the reasons. It's going to be, of course, dose related. This is why we have chosen to do the phase III with three doses in parallel. Let's see the data. There was another question about the CKD.
Precision.
Precision.
Yeah.
CKD. There was a huge interest. There is a huge interest in CKD, but frankly, we are just afraid that these are the same centers as PRECISION, and we really want to finish PRECISION. In addition, we have within PRECISION a lot of the patients who we realize now because we have a significant number of patients who have renal problems and renal impairment. We treat for one year this patient. We are going and we also discuss these studies with the FDA. We are going to get a lot of information about the safety of our drug in patients with impaired renal function. I don't think in this frame, it makes a lot of sense to invest again and to divert attention from the centers to PRECISION study. Of course, once we have PRECISION, everything is open.
CKD study, other studies will be available. We can do it, but then we will have a lot of information and also in terms of safety, it will be maybe much easier to recruit the patients once we have shown the safety and the efficacy of our drug in these patients.
Just to close on the comment with regards to clinical trials, Jacques. Our understanding and our expectation is that by the end of 2021 or spilling into 2022, we should have the data. The data in the database is likely to be an inaccuracy at this point in time.
Thanks very much.
Thank you, Emmanuel. Operator, next question, please.
The next question is a follow-up question of Richard Parkes from Deutsche Bank. Please go ahead. Your line is now open.
Hi. Yes, thanks for taking my follow-ups. First one's just on aprocitentan again. It feels like recruitment's been a little bit slower than you'd hoped for. I'm just wondering to what degree does this just reflect difficulty in recruiting patients that have got documentation that you failed kind of three other therapies versus lack of patients out there. I'm just wondering how that impacts your optimism about the commercial opportunity. Is this just a clinical trial issue or does it reflect kind of the medical need is lower? The second last question, just your competitors conducting a broad program for its CNS penetrating GCS inhibitor, venglustat. I just wonder whether you see potential for lucerastat beyond the initial Fabry's indication. Thanks.
I think that for aprocitentan, what we have seen is from the beginning, a fantastic enthusiasm with this study, with the use of this drug. When you discuss with specialists, and frankly, our evaluation that there are, just in the U.S., 6 million of uncontrolled hypertensive patients. You might have seen recently the new guidelines of the FDA who wants to insist on the fact that decreasing 8 millimeters of mercury count. Decreasing blood pressure is the most sure way of preventing major cardiovascular events, stroke, myocardial infarction. We really see a fantastic interest. Now, you might remind that with the FDA, we have agreed on a very, I would say, sophisticated study. You know that there is a first part of the study where we evaluate 1 month of treatment and then patients are switched and are followed for one year.
Therefore, the total, I think it's today 16 visits. The problem is really to find patients who have a high blood pressure, but it's not really the question. The question is patients who want to go 16 x to the hospital to have the check of their blood pressure. This was needed because the FDA wanted to be sure that after one year, the drug is still working. There is no tachyphylaxis, or there is not an issue. They have agreed that we perform only one phase III trial, but the price to pay is a very complex study, and that's what we see today. We would have had, I would say, 10 x more patients if we would not have this study. If it, for example, we would have been able to follow only for one month. That's the issue, frankly.
It's quite a difficult study to perform.
Perfect. Thank you.
venglustat.
venglustat. We have a chance to have Lucerastat on one side and another product called OGT. Frankly, we will have the choice between these two products to really go to several indications where accumulations of these metabolites or GB3 is playing a role. I'm not saying that we should go with Lucerastat. Maybe we will go with the next product.
Perfect. Thank you very much.
Thank you, Richard. Operator, do we have another question?
Yes. The next question is from Stefan Schneider of Vontobel. Please go ahead. Your line is now open.
Yes, thanks for having my questions. Just on daridorexant quickly. The marketing and distribution is planned from Idorsia or do we expect the partnering for the U.S.? The other one is. Is it possible to specify a bit more clearly what the costs associated for selling and marketing versus administration was 2019 and is also planned for 2020? Thank you.
Maybe, André, can you?
For the second part of your question. Commercial will remain limited because it's really a preparation of launches. Provided that we have positive readouts for daridorexant and clazosentan in Japan. It was CHF 10 million in 2019. It will increase, but will remain limited. It's gated to see a success of the pivotal trials.
Of course, we want to keep control, as I said, on daridorexant, which means we will distribute at least in the U.S. and in Japan, it is shared with Mochida. We are going to keep regulatory responsibility. We are going to keep drug safety, so pharmacovigilance. We're going to keep production, which is under control. Of course, productions, we partner with some factories to make the product, but we are checking the quality, and we are responsible of this production. Finally, medical marketing, because we are going to be responsible to choose other studies, phase IV studies to be made. The commercial operations, we are going to make the branding, we are going to design the strategy.
The question is, of course, we are not going, I can tell you, to recruit hundreds of inside or, I would say, Idorsia medical representative, but we are looking for solutions such as partnering with contract sales organization in order to be able to partner with these organizations and to work with their medical representatives.
We want to keep also payers access.
Of course, payer access. We have somebody who are working, of course, on that. That's something which is going to be key for this product, of course.
Yes. Thank you.
Thank you, Stefan. Operator, do we have further questions?
No, there are no further questions at this time. I would like to hand back to you.
Thank you very much, Angela. Thank you very much for your enduring interest in our story and in Idorsia. Next news flow is prepared to be the first quarter announcement on the 23rd of April. Otherwise, we do have the daridorexant phase III trial for the 301 trial coming through very soon in the second quarter. Stay tuned for that. Thank you very much for your ongoing interest. Operator, close down the lines, please.