Earnings Call: H2 2019

Feb 6, 2020

Good afternoon or good morning to you all from where you're dialing in. My name is Andrew Weiss, and 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 Clazelle and our CFO, Andre Muller. They're here to give you additional color on the results published this morning at 7 am together with the annual report. Please note that we are experiencing a slight technical trouble, so 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 Adorsa shares. With that, I hand over to Jean Paul for his introductory remarks. Thank you, Andrew. Good morning and good afternoon to everyone. It's a pleasure to present to you the progress we have made at eidorsia 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 2 innovative compounds to our pipeline from our drug discovery team. We have advanced each of our clinical programs and we are expecting the 1st 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. And we began building our commercial capabilities and planning the launch of our first products. Now let's discuss these points in a little more detail. So Slide 5, 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. They address a large medical need. Slide 6. Let's look at our late stage assets first. We're expecting the results of the first of the 2 pivotal studies with daridorexan in insomnia in the next few months and the second pivotal study will follow closely behind. Both studies are fully recruited today. Slide 7. The speed at which we have been able to advance daridorexant is very impressive, particularly when you remember that we created eidorsia right in the middle of this program. What potentially differentiates 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 Oraxane, we hope that daridorexant will allow patients to sleep throughout the night, while avoiding the rebound withdrawal of 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, so watch this space. Slide 8. Later in 2020, we also expect to have the results of the Japanese registration study with clazosantan, 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. Clazosantan could really make a big difference for this patient, we seem to make a good recovery from the average, only for the vasospasm to cause devastating effect. The global Phase 3 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 9. 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. Lucerat stat 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 luceratat 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 4 Phase 3 program involves aprociten10, an already active dual on the 3 receptor antagonist investigated in the precision trial for patients whose blood pressure is uncontrolled despite the use of at least 3 anti patented drugs. Because some of the patients, which had to be included in this 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 apocitantan 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, SenereMode, 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 and so far we are making good progress with the recruitment. We may get the results 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 and therefore we are getting ready to initiate the 2nd pivotal study as soon as the current study is concluded. Slide 13. This year, we also shared the results from Phase 2 study and the results in particular, the results of selatogrel, our highly selective P2Y12 receptor antagonist. We have shown that selatogrel demonstrates a very rapid onset of action with the effects lasting between 4 to 8 hours after subcutaneous administration in patients suffering a heart attack. With this efficacy together with the observed safety and tolerability profile, we believe that selatoGraft 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 the subcutaneous QuickShot auto injector. We are now running usability and reliability studies and in parallel we are negotiating an SPA for a large Phase 3 study with the FDA. We plan to initiate Phase 3 in the first half of twenty twenty one. Finally, Slide 14, early stage asset. As I said, we have added 2 very innovative new compounds to the clinical pipeline and this shows the productivity of our drug discovery engine. Furthermore, we have negotiated with Neurocrine an option deal for T TAP calcium channel blocker. As soon as 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. Basically, we aim to be the 1st 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, aprositantan in uncontrolled hypertension, selatagrel in heart attack, senorimod in lupus with EXPERT at the most prestigious medical conferences reaching more than 60,000 key experts. We are also very excited to see our partner Johnson and Johnson reporting data from a successful Phase 3 trial on ponigimod for the treatment of relapsing multiple sclerosis at XTRIMES 2019. This was particularly rewarding because not only are the scientists who discovered ponidine now with Adorsia, but also our revenue sharing agreements with G and G means that quarterly payments of 8% of the net sales of ponazimod are likely to be our first source of regular income. DNG has announced in their annual call 2 weeks ago that they intend to file ponizimod this year. The last point, Slide 16, that I want to highlight is the effort that our Chief Commercial Officer, Simon Joss, 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 Patxi Chatur as President of our U. S. Commercial Organization. As CEO of EYdorsia, 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 Andre, who will take you through the financial results of 2019. Thank you, Jean Paul. Good afternoon or good morning to everyone. So let's go to Slide 17. As you see here, we see EUR 470,000,000 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 EUR 500,000,000 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, euros 24,000,000. This includes €5,000,000 from the R and D collaboration with Roche and the revenue recognition of €19,000,000 regarding Afrocetetan for the development collaboration with Janssen. As said and I will come later on this, non GAAP operating expenses amounted to EUR 470,000,000. So we have a non GAAP operating results of EUR 4.46 euros Including €20,000,000 D and A, €17,000,000 stock based compensation, we have U. S. GAAP operating results of €482,000,000 Below EBIT, you have little non GAAP or cash expenses, roughly EUR 2,000,000 mainly interest expense in the negative interest rate environment and a smaller capital tax. Also rest, roughly €10,000,000 is really non cash expenses, mainly EUR 8,000,000 with the accretion expense, EUR 8,000,000 with deferred tax, euros 4,000,000 relating to CA3's tax reform, euros 4,000,000 relating to the stock based compensation. And we had a gain of €6,000,000 which is actually a mark to market on the Sonterra shares that we received in connection with Sierra DMD compound, Vamorolon. Let's go now to Slide 19, the non GAAP operating expenses. Here you have the comparison between 2018, EUR 399,000,000 and EUR 470,000,000. As you can see, drug discovery is stable at EUR 115,000,000. These are for 90% functional OpEx, I. E, fixed costs. You see the increase mainly coming from the developments going from EUR 215,000,000 to EUR297,000,000. If you break down this €297,000,000 you see roughly that we have functional OpEx around €70,000,000 I. E. A fixed cost base for clinical and pharmaceutical developments. And also rest is really a variable cost including EUR 160,000,000 study costs. This increased by almost €50,000,000 compared to 2018 and a significant portion €61,000,000 relating to drug substance and drug product that we actually need in order to be able to investigate our various compounds in the clinical stage. And this one also increased by roughly €10,000,000 SG and A was more or less stable €58,000,000 versus €54,000,000 Actually, €58,000,000 includes €10,000,000 relating to commercial, where it was close to 0 in 2018, meaning also that the real G and 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. And last year, tough to recall that we paid a milestone in connection with Van Oorland, the DMD compound of €15,000,000 So if we switch to the next Slide 20, regarding cash flow. Left side, you see a milestone received this year is the €5,000,000 upfront paid by Neurocrine with respect to the calcium T channel blocker that Jean Paul just mentioned, compared to last year where we got the EUR 15,000,000 EUR 35,000,000 is Roche with R and D collaboration EUR 15,000,000 EUR 20,000,000 with the sublicense of the DMD compound to Santerra. The operations the funds from operation 473 or 4 0 2 from last year are directly in line with the non GAAP operating expenses that I just mentioned. Difference is really minor, around €3,000,000 relating, as I said previously, to the financial expenses and some minor capital tax. Last year, you may recall that in July 2018, we raised EUR 505,000,000 EUR 305,000,000 in equity, straight equity and €200,000,000 in convertible bonds. This year, we did not tap equity or equity linked capital markets. The CapEx is around EUR 19,000,000 compared to EUR 17,000,000 last year. It's mainly maintenance CapEx, except €5,000,000 this year for a small manufacturing unit that we invested in, 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. And the other is mainly relating to working capital requirements. Let's go to Slide 21, liquidity. I just wanted to go back from the demerger on 16 June 2017. As you know, we demerged from Exelion with EUR 1,000,000,000 cash, EUR 420,000,000 which was cash spun out of Actelion and EUR 580,000,000 with the convertible bond held by Johnson and Johnson. The 6.5 months of 2017, we had €91,000,000 inflow, which was mainly relating to the Apro deal with Janssen and the upfront of $230,000,000 milestone. We discussed already the EUR 129,000,000 in 2018 and the minus EUR481,000,000 in 2019. So we end up the year 2019 with EUR 739,000,000 cash or liquidity. So it means that we are well funded. But to be very clear, we are not funded to breakeven. So I would conclude with the next slide with the guidance, which will be around €500,000,000 non GAAP OpEx or €500,000,000 US40 million dollars U. S. GAAP including stock based compensation and D and A. So as I often said, we again, we see EUR 740,000,000. We are well funded with more than 1 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, Andre. So as you have heard, Hydrosia has achieved a lot in 2019. Our pipeline has dramatically progressed and soon we are going to obtain our 1st Phase 3 results. For a company which is only 2.5 years old, this is unique. The success of the launch of daridorexant will be key for the future of Aydorsia. So in 2020, we will all do our utmost to be ready for this challenge. And now I hand over to Andrew to open the floor for questions. Thank you, Jean Paul. So we have come to the end of our prepared remarks and now I'm now ready to take your questions. Operator, please populate the roster. Thank you very much. And we will now begin our question and answer session. We've received the first question. It is from Richard Parkes of Deutsche Bank. Just start with a couple. Firstly, I just wondered if you could talk about your optimism over potential labeling of duridorexant and how that's impacted by the approval of lemborexant. It felt like your competition seemed very confident about getting an impact on next impact on next day function as class effects versus allowing you a cleaner label? So that's the first one. The second one, just wondered if you could talk a little bit about your current thoughts on commercialization strategy for duradiraxant. Just wondering to what degree the Machida deal in Japan is a guide of what we should expect for global collaborations. Thanks for taking my questions. Okay. So let me answer about your labeling questions. First of all, in the label, I think that even as a company, they are I think that mentioned in the labels and I don't think that driving, you can say drive take your drug and drive afterwards, right, 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. So there are things where I think that the FDA whatever we will see in our studies will have tendency to be very cautious. But we have also made a lot of efforts in collaboration with the FDA. And tell you that the FDA is very, 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 nomborexant are still in the post commercial commitment. So I think that and also the last thing to mention is the fact that we have tested in Phase 3, 3 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 was or 2 doses maximum, but were tested into Phase 3 and there was not any of this flexibility. So I think that we are going to we have done a very, 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. Therefore, there was no way that we could sell a drug on our own in Japan. In the other countries, we have 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, pharmacovigilant, the production responsibility and also the medical marketing role to choose the next study 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 run this way contract sales organization. And we will 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. Your line is now open. Please go ahead. Good afternoon. This is Edward Marks on for Ram. I appreciate you guys taking the questions. We noticed recently that the INSPIRE CKD study was withdrawn from clinicaltrials dot 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, are you do you have any updated timelines for ever starting that study? Yes. Hi, Edward. So we are not going to be pursuing forward with the INSPIRE study. What we're going to be doing is that the efforts that have been put in and starting off that trial 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 the appropriate way to address it. Okay. That makes sense. Just a quick one on cinerimod. I'm wondering when completion of enrollment in the ongoing trial in active SLE is anticipated? Could you repeat the question, please? Enrollment. Yes, sorry. When is completion of enrollment in the ongoing SINARAMOD active SLE trial anticipated? Yes, I think it should be finished End of this year, we are planning to finish the enrollment end of this year. And then it's a 6 month trial, so results will be available next year. Got it. And then finally, you had the recent amendment to the Act 478 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 1 assets? And are any of them garnering particular interest among licensees? Or do you anticipate just self commercializing most of them? I think there is a big gap between the Phase 1 and commercialization. I think that what we have observed is and you can see with the last deals of Novartis and who is ready company is ready to pay €9,000,000,000 while the same asset was €1,000,000,000 or €2,000,000,000 a few months ago that more and more big companies don't like to take risks. And therefore, the value is exponential with time because people are eager to really have late stage assets. And 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. And 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. And that is going to be our strategy. But 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 Greg Sabaatne of Goldman Sachs. Please go ahead. Your line is now open. Thank you and good morning, good afternoon. I've got 3 questions, if I could. My first question has to do with total OpEx for 20 20. And I'm wondering if you could give us a little bit more color around the ramp of R and D and SG and A and how we should think about that relative to what you reported for fiscal year 2019, that would be helpful. So 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 3 studies for duratorexant. 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. And then lastly, if we could just talk about how you're looking at 20 20 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. Andre, you want to take the first question? Yes, sure. Just to give you a little more color regarding the EUR 500,000,000 that we indicated for 2020. This, of course, include positive readouts in for direct direction and for clavozantin in Japan. So we would need to gear up in both countries because we do not have any commercial organization except a very small team that Simon managed to set up here at Headquarter. You've seen the appointment of Pati Tor, who will join us beginning of March. So there's a lot in both countries to prepare for the hopefully launches of daridorexant and clavazantan. Of course, this will be a contingent to positive readouts, mainly for daridorexant, but also for clavozantan. So there is a slight increase, EUR 470,000,000 to EUR 500,000,000 that's mainly driven by the additional commercial expenses. We need also some slightly more G and A because we need also to set up an affiliate in the U. S. And for the rest, I would say, globally, R and D would be in the same range as the numbers that you've seen for the actuals in 2019. And for Dairy Direct Sant, it's very I think you are asking a very good question because expectations are very important. And I think that what we have struggled and we made more than 30,000 products really to select these compounds. And 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 lumborexant and suvorexant, you see a lot of effects during the day. The following day after administration of the drug, you see some no lines, you see side effects, which are due to the very long half life and in case of loborexant, 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 patients with another is going to be. So 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 these drugs in order to avoid the side effects. So 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 1. Let's look at it. Let's compare to the other orexin compounds. Let's compare to the other drugs on the market, number 1. Number 2 is safety side effects. How many patients and we are testing 3 doses, so we choose 1 dose or 1 or 2 doses. Let's look at what are the side effects. Can the 3 doses be given without too much side effects on these 2 doses? We will see with the result. But some not on the next day, next day performance, all these drug interactions, all these effects which are related to the pharmacokinetics of the drug, you have to look at. And finally, and I will not really I will 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 the 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. And this has been a 2 or 3 years effort to develop the PRO specific for sleep, agreed with the FDA. And of course, we are going to see what are the effects 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. So in other words, we have 3 doses and we are going to have to choose the best compromise between the efficacy not only on seed, but on the next day performance. And that's going to help us really to choose the best dose of the drug in this patient. And just follow-up on the financing or liquidity for 2020. Please, Andrew. Yes, well, you're right. And as I Charles said, we're not funded to breakeven. And we I also said that we have different avenues to fund to bridge this funding gap. Of course, the most classical one is the equity capital markets. And here, we will remain opportunistic. We have see a possibility to draw down the J and J credit facility. It's CHF 243,000,000. And as you've seen, Jean Paul went through a pipeline. We have a lot of fully uncovered clinical assets that could be also could be partnered. It takes time. We need also to find the right partner. But also, as Jean Paul said, we need also to get the right value for such assets in such collaborations. So these are the different ways to finance. And at one stage, yes, we'll have we need to action 1 or the other or several of these avenues. Okay. Thank you very much. And we look forward to the Phase 3 data for duratorexant. Thank you. Thank you, Greg. We too. We also. Operator, are there further questions? Yes, there is 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. So Andre, you said at some point you will need to consider additional source 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 for the end of the year at least. Follow-up on darodiraxant. I mean 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 relatively actually modest incidence in both the cevarexant and lenvarexant study, something like mid single digit. Do you expect it to come in low in that? And if so, do you think that is going to serve as a meaningful point of differentiation in clinical practice oprostetentan. I mean, the rationale for discontinuing CKD, does that reflect a lack of medical interest difficulty with patient recruitment? And then if you can just comment on the timing of precision. Clinicaltrials dot 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. Andre, do you want to take the source of capital question? Yes. On a personal note, welcome back, Emmanuel. Thanks for the communication of the coverage. I read it thoroughly. Some disagreement on CSA's but we'll have ample of time to discuss this once we have the launch of the drug. Yes, well, I would not commit to a deadline. Should it be before the end of year, it will depend on the various sources of cash that we could raise. So it might be a combination of the different avenues. So 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. So you can do the math. It's but it will see this is the easiest part and it will depend on the different sources of financing. So come back. Thank you to give me the opportunity to really precise what that was meaning. When we say there is a low incidence in the label for somnolence, if we consider that 7% at 5 milligram of somnolence and 10% at 10 milligram is low, then I agree. But I from my side, I consider it as a 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. And I think this is completely related to the pharmacokinetic or the active metabolites. Nobody knows what is the role played by this active metabolites of lumborexant into this effect. I really I think we this is one of the reasons. It's not it's going to be, of course, dose related. This is why we have chosen to do the Phase III with 3 doses in parallel. And let's see the data. There was another question about the precision. CKD, I don't think it's there was a huge interact. There is a huge interaction in CKD. But frankly, we are just afraid that these are the same centers and the precision and we really want to finish precision. And in addition, we have within Precision a lot of the patients who now we realize now because we have a significant number of patients who have renal problems and renal impairment. And we treat for 1 year these patients. So we are doing and we also discussed 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. And 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. Now 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 of this and the efficacy of our drug in these patients. Yes. And just to close on the comment with regards to clinicaltrials dotgov. Our understanding and our expectation is that by the end of 2021 or spilling into 2022, we should have the data. So the data and 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 Park from Deutsche Bank. Please go ahead. Your line is now open. Hi. Yes. Thanks for taking my follow ups. First one is just on the prostatendan again. It feels like recruitment has been a little bit slower than you'd hoped for. And I'm just wondering to what degree does this just reflect difficulty in recruiting patients that got documentation that you felt kind of 3 other therapies versus lack of patients out there. So 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? Then the second last question, just your competitors conducting a broad program for its CNS penetrating GCS inhibitor, venglustat. And I just wonder whether you see potential for lacerastat beyond the initial Fabry's indication? Thanks. I think that for apocitantan, what we have seen is from the beginning a fantastic enthusiasm with this study, with the use of this drug and when you discuss with specialists and frankly our evaluations that there are 6 just in the U. S, 6,000,000 of uncontrolled hypertensive patients. And you might have seen recently the new guidelines of the FDA who wants to insist on the fact that decreasing h millimeters of mercury count, decreasing blood pressure is a more sure way of preventing MACE or cardiovascular events, stroke, myocardial infarction. So we really see a fantastic interest. Now you might remind that with the FDA, we have agreed on the 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 have followed for a year. And therefore, the total I think is today 16 visits. So 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 times to head to the hospital to have the check of their blood pressure. And this was needed because the FDA wanted to be sure that after 1 year, the drug is still working. There is no tachyphylaxis or there is not an issue. And that's and they have agreed that we perform only 1 Phase III have if we would not have this study, if it, for example, would have been able to follow only for 1 month. And that's the issue. Frankly, it's quite a difficult study to perform. Perfect. Thank you. Benelustat. Benelustat. We have a chance to have Lucerastat on one side and another product called OGT. And promptly, we will have the choice to between these two products to really go to several indications where accumulations of this metabolites or Gb3 is playing a role. And we have I'm not saying that we should go with the serastat, 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 Snyder 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 E Dorsia or is do we expect the partnering for the U. S? And 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, Andre, can you for the second part of your question? Commercial will remain limited because it's really a preparation of launches, again provided that we have positive readouts for daridorax and clazotintan in Japan. So it will it was €10,000,000 in 2019. It will increase, but will remain limited. And again, it's gated to see a success of the pivotal trials. And of course, we want to keep control, as I said, on the rivorexant, which means we will distribute this in the U. S. And in Japan, it's shared with Mochila. But we are going to keep regulatory responsibility. We are going to keep drug safety for pharmacovigilance. We're going to keep production, which is it's 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. And finally, medical marketing because we are going to have be responsible to choose other studies, Phase IV studies to be made. And then the commercial operations, we are going to make the branding, we are going to design the strategy. And the question is, of course, we are not going, I can tell you, to recruit hundreds of inside or I would say, either via 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. And we want to keep also payers' access. And of course, payer access, we have already we have somebody who are working, of course, on that. That's yes, it'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. So thank you very much for your enduring interest in our story and in Audorsia. Next news flow is prepared to be the Q1 announcement on the 23rd April. Otherwise, we do have the daridorexant Phase 3 trial from the 301 trial coming through very soon in the Q2. So stay tuned for that. Thank you very much for your ongoing interest. Operator, close down the lines please.