Idorsia Ltd (IDIA) Earnings Call Transcript & Summary

Good day, and thank you for standing by. Welcome to the TRYVIO (aprocitentan) FDA approval conference call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Andrew Weiss, Head of Investor Relations. Please go ahead.

Good afternoon. Good morning, everyone, and thank you for joining today's webcast to discuss the U.S. FDA's approval of aprocitentan, also soon to be known as TRYVIO. My name is Andrew Weiss, I'm the Head of Investor Relations and Corporate Communications here at Idorsia. To add some color to the press release that was published this morning at 7:00 a.m. Central European Time, we have our CEO, Jean-Paul Clozel; our Chief Scientific Officer, Martine Clozel; our Head of Global Clinical Development, Alberto Gimona, and our President of U.S. Idorsia Organization, Tosh Butt. We will first kick off with some prepared remarks and then take questions. As a gentle reminder, this call is about the FDA approval of aprocitentan. We will be addressing questions on commercial results, OpEx, finance, funding and guidance upon our next scheduled call on the 25th of April. So keep your to questions to aprocitentan, please. Next slide. To our customary disclaimer slide, I do need to remind everyone that in this webcast, we will be making forward-looking statements and have been adequately made aware of the risks and uncertainties of investing in Idorsia shares. Next slide. Jean-Paul, the floor is yours.

Thank you, Andrew. So good morning and good afternoon, everyone. Today is an important day for the millions of Americans whose blood pressure is still uncontrolled despite the use of 1, 2, 3 and sometimes more than 4 drugs. Next slide. Now TRYVIO has been approved by the FDA and will become available in the U.S. in the second half of this year. Next slide. TRYVIO is a unique compound with unique data. First, it is acting on the endothelin system. So it's a new physiological pathway. And since 30 years in hypertension, there have been no drug acting on the new pathway. This TRYVIO has been studied in patients with really well-defined resistant hypertension. We follow the guidelines, and we checked that these patients were uncontrolled despite 3 different type of drugs, diuretics, calcium antagonist and blockers of the renin angiotensin system. This is the first study to my knowledge with such criteria of selection. Third of all, we included in this study, very fragile patients, patients with renal chronic kidney disease, patient with prior myocardial infarction, patients with previous strokes, very fragile population, which usually is not evaluated in this type of study. Fourth, because of the design, which was agreed with the FDA, the program evaluating TRYVIO has been able to prove without any doubt, the durability and the long-term beneficial effect of TRYVIO. All this program has been able to collect a significant amount of data, which I think are very well reflected into the label approved by the FDA. Next slide. Sorry, just what I wanted to say that aprocitentan is -- really is a result of 35 years of research. It has been a long way to get to this type of drug. And Martine is going to really explain the scientific basis of the mechanism of action of aprocitentan and the long path to the discovery of this drug. Martine, please?

Thank you, Jean-Paul. Good morning, good afternoon to everyone, and thank you for joining the call today. The field of hypertension has suffered for close to 40 years by an absence of medical innovation. Despite the fact that it was more and more recognized that blood pressure should be kept at a very low level to help the best long-term prognosis, remember, hypertension is the #1 modifiable risk factor for death in the world. Next slide, please. All drugs in the last 40 years and several new molecules currently in development, are all concentrating on the inhibition of a more and more crowded renin-angiotensin-aldosterone system space. Angiotensin receptor blockers, aldosterone receptor antagonist, aldosterone synthase inhibitor, even now siRNA against angiotensin enzyme. TRYVIO is the only molecule to target a system which has never been tackled in systemic hypertension, the endothelin system. And we hypothesized that it was a major player in hypertension because endothelin is closely associated with short-term hemostasis and difficult-to-treat hypertension is [indiscernible]. And because endothelin causes vasoconstriction, vascular and cardiac remodeling and fibrosis, inflammation, release of aldosterone and release of catecholamine. We hypothesized that endothelin could be a major cause of difficulty to control in hypertension as no existing antihypertensive drug or mechanism has any effect on an activity on the endothelin system. Next slide. As you know, we have been working for more than 35 years on the endothelin system. I was even trying to identify the peptide responsible for the short-term vasoconstriction and cell proliferation and produced by human endothelial cells even before endothelin was discovered and named endothelin. Our conviction of the role of endothelin in systemic hypertension came from that early time, followed by the 1998 first evidence of the blood pressure lowering effect of bosentan, but its liver liability precluded a new application for systemic hypertension. The field attempts by competition developing selective ETA receptor antagonist in hypertension and the perseverance and continuation of our research, for novel dual endothelin receptor antagonists for systemic hypertension, culminating in the development of aprocitentan. And in 2022, the positive outcome of PRECISION, our Phase III study. Next slide, please. Aprocitentan is an ideal molecule for this indication in these patients. Once a day, with very low potential for drug-drug interaction or liver liability. Aprocitentan is blocking effectively the 2 types of endothelin receptors responsible for the [indiscernible] effect of endothelin ETA and ETB receptors. It is synergistic in animal models with other antihypertensive and it demonstrated very good blood pressure lowering effect and very good safety as a monotherapy in a Phase II study in patient with systemic hypertension. Next slide. With TRYVIO, we have discovered the first and only endothelin receptor antagonist now approved for patients with systemic hypertension, when their blood pressure is not adequately controlled by other drugs. TRYVIO not a decrease blood pressure in patients with hypertension, in general, our Phase II, but you will see in the presentation of Alberto that it also decreases blood pressure in patients selected for their true and confirmed resistance to at least 3 antihypertensive drugs. These patients have often risk factors for hypertension, especially difficult to treat. Africa Americas, obesity, obstructive sleep apnea, older age, renal failure, diabetes. In these patients, we predicted that hypertension should be dependent on endothelin. This is why they were resistant to prior drugs, even at the highest dose and given in combination. The efficacy of TRYVIO is a highlight of our Phase III program, the PRECISION trial. With that, I'm happy to hand over to Alberto, who will remind you of this data, which led to the approval of TRYVIO and put in the context of the FDA-approved label. Next slide, please. Alberto.

Thank you, Martine. Good afternoon, good morning, everybody. It is my pleasure to present to you the data underpinning the major feature of the USPI for TRYVIO. Of course, I cannot present all the data in the submission, so I must start saying that with TRYVIO, we have a remarkably consistent effect on blood pressure across all the end points and different methodologies, office blood pressure measurements, ambulatory 24-hour blood pressure measurement. And probably most importantly, across subgroup. In particular, CKD, chronic kidney disease and particularly important for the U.S., African Americans. Next slide. This slide, you see the design of a PRECISION trial. The design was, I would say, discussed, but more than discussed inspired/fired by the FDA. It was a very efficient way of providing efficacy data to support new medication in the field of hypertension, which is, as we already said, underserved. I would summarize that it was 2 studies in 1. There was a long screening period in green on the left to select a truly resistant population, hypertensive population with 1 pill to cover the 3 other medications that the patients should have been on and a running period. This was followed after randomization that a full week -- doses finding study, 25, 12.5 and placebo, followed by a single blind and a withdrawal part of 12 weeks to confirm the persistence of the effect. Next slide. In this slide, you see the characteristics of the population that we recruited. As Jean-Paul said, this is a very frail and sick population, here highlighted in blue some of the characteristics. But before that, actually, you look in the middle at the top that we have 60% -- actually over 60% of patients that were not on 3, but 4 or even 5 or more than 5 medication at baseline. So the effect observed with aprocitentan at these doses was observed on top of many medications. Indeed, we have rigorous inclusion criteria, but actually inclusive exclusion criteria in the sense that we were able to select population, which was consistent to what you observe in real world. And this is very important. So we have 50% of patients with diabetes, 20% and even more actually with patients of congestive failure. On the left, you see elderly people with quite a significant number of patients, African American they represent 30% of the population recruited in the U.S., and the population was obese. We had even 14% of extreme obesity with BMI over 40. Importantly, though, on the bottom of the central line -- column you have a significant population with renal problems defined as lower GFR down to 15, so down to end-stage renal disease, we have 22%. But on top of that, we have also additional patients who were not yet on the CKD 3 and 4, but still have proteinuria. And you see that we have approximately 36% of patients with micro proteinuria or even macro proteinuria. So a very sick population, a very relevant percentage of patients in chronic kidney disease. Next slide. Now, this slide is important, in my view, to put the data into the perspective. On the left, with the arrows to the top you see that those patients with uncontrolled hypertension are almost a double of the risk of the same patients without -- with control hypertension of ending into end-stage renal disease. 90% are failure and so on. 90% at the increased risk compared to patients control. But what I think is most important, in my opinion, is the graphic on the right. So on the right, you see on the y -- on the x-axis, you have the time from initiation of observation, almost 4 years. And the different capital on Myers lines, starting with the black one, provide the risk of developing cardiovascular events over the next 4 years. And on the Y-axis, you have -- you may not see it very well, but you have the increased risk. And you see that in the population included in the precision, we were on 3, 4 or 5, which are the top line -- the top 3 lines, the increased risk compare to those noncontrolled with less than 3 medications is more, 25% versus 15%. So very relevant population in which to show the decrease of blood pressure. As mentioned by the way, in the USPI and if you read in the first section, not everybody looks at this section. It showed that the benefit -- expected benefit in a population at higher risk provide more -- a greater absolute benefit. Next slide. Here, you know already this slide is the efficacy data from the 3 parts of the study, we have a decrease of approximately 15-millimeter mercury at 4 weeks, and you see that there is no difference between 12.5 and 25. Nice demonstration of durability of the fact by means of the Part III of the trial, in which while withdrawing the drug, then you have an increase in blood pressure. Next slide. Now how this is translates in the SPA? And here are the highlights. Here, you have the indication in usage, 2 things for me are important, 2 facts, actually. First, TRYVIO is not restricted to a population already on 3 antihypertensive drugs, but can be used more generally -- liberally, if you wish, on those patients not control on other drugs or may be important, not tolerating other drugs. It's not uncommon that patients who are being on RAAS inhibitor or calcium antagonist afterwards, they are out. They have tried it, but they are not tolerating those drugs. And these are population that is still eligible for TRYVIO. Second, and again, a little bit -- what I'm going is that it's recognized in the label in the USPI of TRYVIO that by decreasing blood pressure, TRYVIO is reducing the risk of major acute cardiovascular events. Next slide. Now I come back, sorry, I put it back again the slide that the risk of developing cardiovascular over following 5 years that I just showed. Remember, the population in precision have between 20% and 25% of risk of getting a cardiovascular event over the next 48 months. Next slide. Now let me guide you through these 3 dimension graphic. This graphic represents bars, the bars in this graphic represent how many cardiovascular events, a treatment can save by 2 factors -- by acting on 2 factors. The reduction in blood pressure from baseline in the x-axis on front of the slide, you see the numbers, minus 4, 8, 12, 16, by reducing by that amount of millimeter of mercury. And then on the z-axis, so the access as go to the end of the slide, you have the risk of the population being treated and in which we observed that decrease. The 2 arrows, the red arrow here show the effect observed with aprocitentan, 16-millimeter decrease from baseline plus the other arrow on the right, the risk of this population that we recruited in the precision. This may end up with 69 events of cardiovascular events, myocardial infraction, stroke, coronary artery predominantly as written in the USPI over the next 5 years. So a great effect can be expected. Of course, and you see on the bottom left of the slide, we need to say that these data are not produced with aprocitentan, but this is what the label implied. Next slide. Let's go to Dosage and Administration and Section 14: Clinical study. The approved dose is 12.5 million once daily. We have always proposed 12.5 milligram as a target dose of starting dose as the effect observed with this dose is already very compelling over and across subpopulation. And please note that in Section 14, there is a recognition in the USPI that the effect has been the persistence of the BP lowering effect has been demonstrated in the study. Next slide. Now extremely important in the label, I think it is the acknowledgment that efficacy of TRYVIO is consistent across the group and particularly in CKD patients, whether or not with concomitant proteinuria. The addition of the wording on consistent across ambulatory and an attended office BP measurement is also important to allow us to use the powerful data that we have produced on the 24-hour ambulatory blood pressure measurements. Next slide. Here, you see in the [indiscernible], the consistent effect observed with TRYVIO 12.5 milligram on systolic blood pressure and then on 24-hour daytime, systolic and nighttime. Of note, the nighttime is the effect observed on nighttime systolic blood pressure is remarkable as nighttime mean systolic blood pressure is a strong predictor of cardiovascular event. As I mentioned at the beginning, I have -- we have no time to show a lot of data, but the data on diastolic blood pressure are also very similar to those ones. Next slide. Efficacy is consistent across the group. Here, you may have seen this, this data that we have presented already. The efficacy -- the effect of in the overall population is confirmed, and I would say sometimes amplified in patients we moderate in CKD stage 3, 3a and 3b, and severe CKD stage 4 for chronic kidney disease. We decreased from baseline up to 11-millimeter mercury. This is an ambulatory blood pressure where you usually have less of an effect. But here, we have very nice recognized by our experts as well as extremely important in this population who is really demanding for new treatments. And you see also that the difference versus placebo are impressive. Next slide. Now very quickly on safety. First, I would like to clarify that there is -- in the USPI Section there is a starting warning that reflect actually the warning and precaution section that reflect the class label for teratogenicity, hepatotoxicity, or no risk on this population like heart failure, rather than adverse drug reaction on aprocitentan. Indeed, what has been observed and we recognized by the FDA as adverse drug reactions is only the 2 that you see in the table. Edema/fluid retention and anemia, both well-known effects, especially anemia or [ dilution ] with endothelial receptor antagonist and edema/fluid retention, which I would like to go a little bit more in detail in the next slide. In this slide, you see the incidence of edema by 4 weeks period. So instead of -- actually before the treatment, and you see that the vertical dotted line is the discriminator with between pre-randomization once where there was no aprocitentan -- sorry to call it like this. And after randomization, when TRYVIO was introduced. And I would like also to remind that due to the study design, after 4 weeks, the patients were on switch to 25-milligram aprocitentan. You see that already before randomization the incidence of edema is between 1% to 4%. It's true that during the first 2 to 8 weeks, you observe an increase to 9% in the first 4 weeks, coming down to 5% at week 8. After week 8, the incidence of edema is basically the baseline entity. So very nice data on edema. But these are only the incidents. As a reminder, I would just like to recap that over 90% of edema were peripheral leg edema, mild-to-moderate in nature, did not induce, require discontinuation. Only 1% of patients, 7 patients discontinued the [ study ] due to edema. Additionally, this edema care has also reflected in the USPI can be treated with the short course of additional diuretics. Now we have a final slide on REMS. Next slide. I'm also happy to share that we have what I would score an easy REMS for patients, physicians and pharmacists. The only requirements are for prescriber to certify by means of the simple 8 -- question knowledge assessment and also the pharmacies need to be certified. But the main feature of the REMS, and I think this is the main win that we have here is that patients do not need to enroll, which distinguish this REMS from other REMS for other events. And importantly, although the patients should be counseled taking contraceptive to the entire duration of the study, as mentioned in USPI, there is no need, no requirement to collect any pregnancy test to obtain a prescription. So it's much easier for the prescriber and for the patients. In addition, there is no requirement that the prescription is limited to 30 days as for other drugs. So final word, the REMS that we are able to negotiate is the easiest REMS compared to all other REMS and not only among [indiscernible], but any 15 available REMS at this point. With that, I would like to hand over to Tosh to next slide. Thank you.

Thank you, Alberto. Well today is indeed exciting news for the millions of patients in America who despite taking their blood pressure medicines, still do not have their blood pressure adequately controlled, leaving them exposed to an increased risk of fatal and nonfatal cardiovascular events, primarily strokes and MIs, myocardial infractions. TRYVIO is the first oral anti-hypertensive tablet, which worked via a new therapeutic pathway to be approved in almost 40 years. TRYVIO has just approved by FDA for the treatment of hypertension in combination with other hypertensive medicines to lower blood pressure in patients who are not adequately controlled on other drugs. The approval of TRYVIO is a significant medical breakthrough in the field of hypertension and blood pressure control. And at Idorsia, we are proud to bring a potential new solution for physicians and patients. Next slide, please. Hypertension is the leading modifiable risk factor for early death and disability. The importance of getting baseline pressure under control is very well established. We know that lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events. We also know that over 90% of these patients who are taking 3 or more hypertensive medications also have overlapping comorbidities. And these patients have a 2- to 6-fold greater risk for myocardial infarction, stroke, end-stage renal disease and cardiovascular and all-cause death compared to those patients with hypertension that can be controlled on 3 or fewer medicines. And it is well-documented that a 5-millimeter reduction in blood pressure can deliver a 10% reduction in the risk of major adverse cardiovascular events. Next slide, please. When we analyze patient claims data, we estimate approximately 8 million patients are immediately addressable with TRYVIO. To get to this 8-million patient count, what we have done is to consider those patients who essentially mirror the patients we studied in our Phase III precision study. There are approximately 3.5 million patients who are taking 3 medicines or they've tried 3 medicines for their hypertension, but are still not adequately controlled. In addition, there are approximately 4.6 million patients who are taking or have tried 4 plus medicines for their hypertension. This gets us to the approximate 8 million patient number, again, in line with our Phase III PRECISION study. Now I will say we feel we're being a little conservative here and appropriately so, because we're not including those patients who are taking 3 medicines, who yes, they might be controlled, but they're not happy. They're not happy with the side effects they're experiencing or they may be overwhelmed with the different dosing regimes or their cocktail of medicines, and potentially a once-daily add-on medicine could be a viable alternative. But as I said, we are not focused on including this patient cohort in the 8-million patient count. Next, another important point is yes, blood pressure treatment today, they are generic, but over 90% of these patients have comorbidities, including metabolic diseases, such as diabetes, obesity, dyslipidemia the overlapping cardiovascular comorbidities, including heart failure, coronary artery disease and peripheral arterial disease and/or CKD, i.e., these patients can be renally impaired. And this means they're also taking branded medicines for these overlapping co-morbidities. Next slide, please. When we look at the study population in our Phase III PRECISION study, once again, i.e., patients treated with 3 or more hypertensive medicines, we see that around 60% of these patient types are being treated by at least 2 or more physicians. Around 50% to 60% of these patients are being treated by cardiologists and nephrologists. And the remainder are seen by primary care physicians. We're still conducting further deeper analysis in this area, specifically because we want to get greater clarity on which physicians are responsible for most of the initiation and prescribing decisions of these hypertensive medicines for this specific patient type. And this is data analysis we expect to have in the coming weeks. And this will inform our future decisions. So more to come here in due time. Next slide, please. Early feedback from the payers indicates a few things. First, they recognize the unmet need for uncontrolled hypertensive patients. They have a favorable reaction to the design of our Phase III PRECISION study, and they view our blood pressure improvement on top of 3 or more hypertension medicines as clinically meaningful. And at the same time, they have their processes and SOPs, meaning TRYVIO will be accessible in 2024 and in part of 2025 via the on-formulary medical exception process until the new-to-market block in Medicare and the NDC block in commercial are removed. We do not expect any Medicare Part-D access in '24 -- in 2024 or 2025. We will be aiming for some commercial access in 2025. We will be submitting our Medicare Part D bids in the fourth quarter of this year, January '26 inclusion. Next slide, please. So we try to summarize the key aspects of why TRYVIO can be a paradigm-changing addition for physicians and patients in the treatment of uncontrolled hypertension. First of all, this can be achieved from one dose, 12.5 milligram tablet once daily with or without food, irrespective of their background medication, comorbidities, including those patients who are renally impaired. And this is an important differentiator versus some existing treatment options and those in pipeline development. No clinically relevant drug-drug interactions requiring any dose adjustment, it remains one 12.5 milligram tablet for all patients. The side effect profile Alberto referred to is manageable; TRYVIO 12.5 milligram once daily has a REMS program, which we will be putting in place, and this REMS program will require a onetime physician and onetime pharmacist registration and certification, and there is no patient enrollment or patient registration requirements. In addition, TRYVIO 12.5 milligram once daily has a half-life of 41 hours. And so this could provide some potential cover for any suboptimal adherence. Now before I hand over to Martine, our Chief -- Martine Clozel, our Chief Scientific Officer, let me finish by saying that Idorsia, we look forward to making TRYVIO 12.5 milligram once daily tablet available in the U.S. in the latter half of this year for the millions of Americans who despite taking blood pressure medicines still do not have their blood pressure under control thereby exposing them to an elevated risk of fatal and nonfatal cardiovascular events, primarily strokes, MIs. Let me hand over to Martine, our CFO. Next slide, please.

Thank you very much, Tosh. With this long-back approval of TRYVIO in hypertension, we are entering the world of non-orphan indication for an endothelin receptor antagonist. The properties of TRYVIO, which I think underlie its efficacy in hypertension -- in systemic hypertension can be applicable to other large cardiovascular indication. With all the information from the subgroups of patients, which forms a particularly severe population of the PRECISION study, the future is now open to the investigation of TRYVIO in additional large cardiovascular. Therefore, big opportunities for aprocitentan going forward. And with that, I hand over to Andrew to take us through the Q&A session. Next slide.

Thank you, Martine. So we've come to the end of our prepared remarks and now ready to take questions from you. In terms of logistics, I only have 2 points. Number one, may I ask that you ask one question and jump back into the queue. Number two, a gentle reminder that this call is about the FDA approval of aprocitentan, and they will be addressing questions on commercial success, operational costs, finance funding and guidance at the financial call on 25th of April. So keep your questions to apro, please. Operator, please open the lines.

[Operator Instructions] And now we are going to take our first question, and it comes from the line of Peter Verdult from Citi.

It's Peter Verdult from Citi. I'll stick to the rules even though I've got a lot of questions, but congratulations on the approval. The excitement at the dose here is clearly palpable and as you said, the addressable population is large. So forgive me, I just want to sort of square this excitement with some other fair observations. Number one, the Lancet editorial, [indiscernible] trial design, one could characterize the editorial is lukewarm in terms of the apro proposition. Your former partner, a cardiovascular powerhouse handed back the rights, you can't ignore that fact. And that -- this data has been on the market or being publicly available for a number of months or approaching years and a follow-up partner has not been found. So help me square the excitement at the dose here for the drug and the opportunity you see with those observations because just working in Europe and you said yourself, you are launching this in a generic market, and this almost feels like QUVIVIQ 2.0, that was the same sort of dynamic and we know how the commercial success of that product played out?

Okay. So thank you, Pete, for your question. And with the large number of topics. So you want quickly just how we square our excitement based on the fact that the feedback from you is lukewarm Lancet editorial J&J returning the rights and we don't have a partner at this point in time. I think Jean-Paul, if you want to take a larger view on this.

First of all, it's certainly not a generic market because no drug is approved for uncontrolled hypertension. It's on top of generic like it is like -- makes it very different from any generic drug. So that's, I think, a very wrong assessment. Second part of it is why J&J didn't give up -- did give up this drug is not the first time they do it. They did it with macitentan with close to sell it for CHF 2 billion, and they give the drug back and they bought it back for CHF 30 billion after 10 years. So it's not the first time that J&J does a mistake. Third point is that why we didn't find a partner. And simply, we just got the drug back in just in -- was it in September or I think it was in September. And then the PDUFA was very close. So now the label is very clear. And -- now any potential partner can make his decision. So I think that this is really a fantastic opportunity. I think I'm really not worried by the potential commercial success. It's a very different case from QVD where we had really, a very -- we had with a question of scheduling some uptake, and this scheduling was used by payers. We do not have at all such a case. It's not at all be within the generic market. So I think it's a very, very different situation. And I am absolutely convinced that it's going to be a very big commercial success with or without a partner, we'll see. And Tosh is assessing the best strategy for us. We will see how many patients -- how many prescribers we need to contact, and we will see what is the best strategy for us to continue.

Thank you, Jean-Paul.

I can maybe a word -- Alberto here for the lukewarm editorial. I think -- what for me is more important was to get the feedback from the patients in the study and for the health authorities. I think the label that we just received translate well the value of this drug. And I think it's the patients that stay in the trial because we were estimating more patients to drop because all the expert, the famous expert [indiscernible] write the editorials, say "All your studies too long, you cannot -- and the patients were staying with adherence to the treatment and to the study for longer." So for me, it's equally important, if not more important, that both of the patients that stayed in the study and the feedback of the health authorities as compared to some editorials.

Now we're going to take our next question. And the question comes from the line of James Gordon from JPMorgan.

James Gordon, JPMorgan. Yes, my question is where are you looking to make the divestment versus investing yourself behind the launch? So I think you said in the release that you plan to make the product available in the second half. But is your plan very much that you are going to launch it yourself? Or you might hold back of it until you find it where you are on the divestment because you sound quite excited. So does that mean you're going to invest heavily in launch? Are you already hiring a sales force and things like that? And where are we on the divestment plan? So are you in late discussions? Do you hope to have those completed by the time of the Q1 results? Or should we be a lot more patient, I think it could quite some time to get a divestment announced?

Thank you, James. So I'll hand the question to Jean-Paul for more strategic note on it and then give it to Tosh to give some more operational tactical appreciation.

Yes. So just, James, we got the drug back in September. And frankly, it was supposed to be launched by Johnson & Johnson. So we now have to make the evaluation of the number, and this was mentioned by Tosh. And -- who was the prescriber? How many reps do you need? How many MSLs you need? And before we have this data, which are going to come in the coming weeks. Now that we have the label, we can discuss with the payers, we can show them the label. It's not anymore a hypothesis. It's a fact. So now we are evaluating what is the best strategy. Is it -- and we will see in the coming weeks what is the best way to do it. So we are not recruiting for the time being ourselves, we are evaluating the best strategy.

Thank you, Jean-Paul. Tosh, do you want to add to that?

Yes. Andrew, yes, if I can go ahead. So look, we just received FDA approval. And so for the moment, as Jean-Paul said, we are clearly evaluating the best options for the launch itself. So we're evaluating all options, including sales force sizing, sales force deployment. And look, we plan to make the drug available later in the year. But at the same time, we're getting ready for launch, and we are engaging with payers. We're continuing to induct our market research and key opinion leader engagement. We're building out the REMS platform. We're also establishing our distribution channel. And as Jean-Paul said, we'll get data in the coming weeks that allow us to establish what size of field force we will require and what size of MSL team we will require. So all this work will be done in the coming weeks and months.

And the next question comes from the line of [ Laura Pfeifer ] from Actelion.

And also congratulations for the approval of TRYVIO. Maybe now that we have seen the FDA approval, what are your thoughts or expectations for the approval process in Europe? I think the CHMP opinion is awaited in Q2. Maybe now what kind of difference should we expect any thoughts here would be appreciated.

Thank you, Laura. Alberto, do you want to provide a little bit of color as to where we are?

Where we are, we are in the closing steps toward an opinion of the CHMP. I would expect, again, this may change. I would expect sometime in April -- between April and May, we're receiving the last questions that we need to address very shortly. So again, I don't want to engage anybody here, but myself, I'm quite confident of a positive outcome. And what I would say, certainly, there are differences in the approach between health authorities as we already see many times. And so -- but with that, let's see and wait, but I'm quite confident at this point.

Now we're going to take our next question. And the question comes from the line of Peter Verdult from Citi.

Just a follow-up maybe for Tosh and a clarification. Anything you're willing to say right now in terms of a price point that relates to the U.S. market. And I just -- I don't quite understand evaluating all options. I thought the situation with the doses that you are resource constrained. And obviously, you've got cash to the end of the year, but do you really have the resources to launch this drug on your own, so you declare. I realize we're not talking about corporate staff in April, but as it relates to apro, just I want to understand, evaluating all options, do you believe you have the resources to fund on your own? And are you going to sell on the price point or likely price point that you're seeking in the U.S.?

Okay. Thank you, Pete. Tosh, let me take the pricing question and then we'll take the strategy question to Jean-Paul, please.

That makes sense. Yes, Pete, thank you for your question. The WAC price, the wholesale acquisition cost or list price, we intend to publish that in the coming weeks.

And just for the strategy, we have several options. I think we will discuss it in April. I think we just made a significant deal with Viatris and some other things are, of course, cooking. So I think that we absolutely want to be in a situation to -- if we -- even if we want to partner, we want to be in a situation to know exactly the potential of the drug, the potential sales, the potential costs, which are involved with aprocitentan with TRYVIO. And we have the chance here to have an organization in place in the U.S. under the leadership of Tosh. Tosh is a very experienced person. He knows very well cardiovascular. He was in AstraZeneca. He was in many companies, involved with many launches. And now we have -- and this has been in contrast with what happened with QUVIVIQ where we had to build this organization from scratch. And now we have an organization in place with very experienced people in cardiovascular, especially in cardiovascular. And we are in a good situation where we can evaluate this market, this potential without spending money in addition to what we spend for the operations which are for QUVIVIQ in the U.S. So it is not additional money that we spend, but we have the manpower to do this evaluation, and we will not take a decision before knowing exactly what is needed for launching aprocitentan in the U.S.

[Operator Instructions] And now we're going to take the next question. And the question comes from the line of [ Laura Pfeifer ] Actelion.

Also just a short follow-up. So do you plan to conduct further clinical studies now after approval?

Sorry. Alberto?

Yes. I say because it's -- I would love. And I think that there is a huge potential and not for -- not for a chance, I put the great data that we have in CKD. As you may have seen, we published data showing that in the CKD population, we decreased proteinuria by 60%, which is remarkable. So I would clearly love doing a big program in this population. But I'll let...

But of course, and this is one of the aspects that we have to discuss with a potential partner is a partner going to develop to go with the other indications. This was planned with Johnson & Johnson. But now we have a lot of opportunities. Now we can launch in resistant hypertension, but we can also go to many other indications. And for me, it's obvious that renal disease, CKD, is obvious, we have such -- we have never seen -- I don't think it has the effect that we have observed with apro is unprecedented. So we have many opportunities. And this is part of the complexity of the decision-making because this is not a simple decision, and we will take what is the best decision for the patient, for the company, for the shareholders, we need to take into account all aspects.

Now we're going to take our next question. And the question comes from line of Sushila Hernandez from Kempen.

Maybe this has been addressed before, but my line got disconnected. So you mentioned that you will take your time to review your strategy for aprocitentan. So just on the strategy part, do you then have the resources to continue your operations to bridge this point to look into your strategy? Yes, it's my question.

Yes. If I understand well, you are asking, do we have the people to do that and we have the capacity. And I just mentioned maybe you could not -- because your line was closed. But as I said, we have a lot of people -- we have an organization in place, and I said that Tosh is a very experienced leader who has launched many cardiovascular drugs. He has experience with this type of product. And we have also the chance to have in market access, in medical affairs, people who have a lot of experience in cardiovascular. And therefore, we can now do the analysis without spending more money, without recruiting people. And that's why we want to spend the time before we take a decision. Of course, people think to -- I've heard they say, "Why is it not partner already?" But do you think that people are going to make any deal a few days before the PDUFA. They would put a lot of money and you never know what is the potential risk with any approval. So I think now we are in a very clear situation. We have the label. We have -- we will have in a few weeks the marketing assessment and then we'll be able to do the best. And when I say we will discuss in April, what means doing the best also in terms of financing. And we -- of course, we are very aware of the financial situation, and we are working on that and our CFO and many people are working very hard after the very significant deal, which we have done with Viatris, which is very important because now we do not have 2 big Phase III to spend money on, and this gives us a lot of more flexibility for our future decisions.

Thank you Jean-Paul. Operator, next question please.

Dear speakers, there are no further questions. I would now like to hand the conference over to your speaker, Andrew Weiss, for any closing remarks.

Thank you very much. So we've come to the end of today's webcast. Thank you very much for your attention and your interest in Idorsia. Our next scheduled communication will be, as I said before, the full year results and first quarter '24 results on the 25th of April, where we'll be giving more data on financial performance and guidance. So operator, please close down the lines.

That does conclude our conference for today. Thank you for participating. You may now all disconnect. Have a nice day.