Good day, and thank you for standing by. Welcome to the TRYVIO Aprocitentan FDA Approval Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question-and-answer session. To ask a question during the session, you need to press star one one on your telephone keypad. You will then hear an automatic message advising your hand is raised. To withdraw a question, please press star one one again. 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. Thank you for joining today's webcast to discuss the US 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 the US 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.
Keep your 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 to 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 one, two, three, 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 drugs acting on a new pathway. This TRYVIO has been studied in patients with really well-defined resistant hypertension. We followed the guidelines, and we checked that these patients were uncontrolled despite three different types of drugs: diuretics, calcium antagonists, 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 chronic kidney disease, patients 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 really is a result of 35 years of research. It has been a long way to get to this type of drug.
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 have the best long-term prognosis. Remember, hypertension is the number one modifiable risk factor for death in the world. Next slide. 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 antagonists, aldosterone synthase inhibitors, even now siRNA against angiotensinogen . TRYVIO is the only molecule to target a system which has never been tackled in systemic hypertension: the endothelin system.
We hypothesize that it was a major player in hypertension because endothelin is closely associated with salt homeostasis, and difficult-to-treat hypertension is often salt-sensitive, and because endothelin causes vasoconstriction, vascular and cardiac remodeling and fibrosis, inflammation, release of aldosterone, and release of catecholamines. We hypothesize 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 activated 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 this potent vasoconstriction and cell proliferation and produced by human endothelial cells even before endothelin was discovered and named endothelin.
Our conviction of a 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 any application for systemic hypertension. The failed attempts by competitors developing selective ETA receptor antagonists 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 and these patients: once a day, with very low potential for drug-drug interaction or liver liability. Aprocitentan is blocking effectively the two types of endothelin receptors responsible for the deleterious effect of endothelin ETA and ETB receptors.
It is synergistic in animal models with other antihypertensives, and it demonstrated very good blood pressure-lowering effect and very good safety as a monotherapy in a Phase II study in patients 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 only decreased 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 three antihypertensive drugs. These patients have often risk factors for hypertension, especially difficult to treat: African Americans, 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. He will remind you of this data which led to the approval of TRYVIO and put it 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, though I must start saying that with TRYVIO, we have a remarkably consistent effect on blood pressure across all the endpoints and different methodologies: office blood pressure measurements, ambulatory 24-hour blood pressure measurements, and probably most importantly, across subgroups, in particular CKD, chronic kidney disease, and particularly important for the U.S., African Americans. Next slide. This slide, you see the design of the PRECISION trial. The design was, I would say, discussed, but more than discussed, inspired 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 two studies in one. There was a long screening period in green on the left to select a truly resistant population: hypertensive population with one pill to cover the three other medications that the patient should have been on, and a run-in period. This was followed after randomization by the four-week 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 I 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 three, but four or even five or more than five medication at baseline. So the effect observed with aprocitentan at this dose 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 a population which was consistent with what you observe in the real world. And this is very important. So we have 50% of patients with diabetes, 20% and even more, actually, with patients on congestive heart failure. On the left, you see elderly people, quite a significant number of patients, African Americans. 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 a low eGFR 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 III and IV but still have proteinuria. And you see that we have approximately 36% of patients with microproteinuria or even macroproteinuria. So a very sick population, a very relevant percentage of patients with 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 have almost the double of the risk of the same kind of patients with controlled hypertension of ending into end-stage renal disease: 90% heart failure and so on, 90% increased risk compared to patients controlled. But what I think is most important, in my opinion, is the graphic on the right. So on the right, you see on the X-axis, you have the times from initiation of observation, almost four years. And the different Kaplan-Meier lines, starting with the black one, provide the risk of developing cardiovascular events over the next four years. And on the Y-axis, you have you may not see it very well, but you have the increased risk.
You see that in the population included in the PRECISION, we were on three , four, or five, which are the top lines, the top three lines, the increased risk compared to those not controlled with less than three 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, nobody not everybody looks at this section, it showed that the benefit, expected benefit, in a population at higher risk provides a greater absolute risk. Next slide. Absolute benefit. Next slide. Here, you know already, this slide is the efficacy data from the three parts of the study. We have a decrease of approximately 15 millimeter mercury at four weeks. And you see that there's no difference between 12.5 and 25.
Nice demonstration of the durability of the effect by means of the part three of the trial in which, when withdrawing the drug, then you have an increase in blood pressure. Next slide. Now, how this is translated in the USPI? Here I have highlights. Here you have the indication and usage. Two things for me are important, two facts, actually. First, TRYVIO is not restricted to a population already on three antihypertensive drugs but can be used more generally, liberally, if you wish, on those patients not controlled on other drugs or, maybe important, not tolerating other drugs. It's not uncommon that patients who have been on RAAS inhibitor or calcium antagonist, afterwards, they are out. They have tried it, but they are not tolerating those drugs. These are a population that is still eligible for TRYVIO.
Second, and again, a little bit where I'm going, is that it's recognized in the label, in the USPI about TRYVIO, that by decreasing blood pressure, TRYVIO is reducing the risk of MACE. Next slide. Now, I come back. Sorry. I put it back again, the slide, that the risk of developing cardiovascular events over the following five years that I just showed. Remember, the population in PRECISION has between 20%-25% of risk of getting a cardiovascular event over the next 48 months. Next slide. Now, let me guide you through this three-dimensional graphic. This graphic represents the bars. Actually, the bars in this graphic represent how many cardiovascular events a treatment can save by two factors, by acting on two factors: the reduction in blood pressure from baseline in the X-axis.
On the front of the slide, you see the numbers -4, 8, 12, 16 by reducing by that amount of millimeter of mercury. Then on the Z-axis, so the axes go to the end of the slide, you have the risk of the population being treated and in which we observe that decrease. The two arrows, the red arrows 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 infarction, stroke predominantly, as written in the USPI, over the next five years. So a great effect can be expected, of course.
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 implies. Next slide. Let's go to dosage and administration and the Section 14, clinical study. The approved dose is 12.5 milligrams once daily. We have always proposed 12.5 milligrams as a target dose or starting dose, as the effect observed with this dose is already very compelling overall and across subpopulations. Please note that in Section 14, there is the 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 the efficacy of TRYVIO is consistent across subgroups, and particularly in CKD patients, whether or not with concomitant proteinuria.
The addition of the wording on consistency across ambulatory and unattended 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 PRECISION plot the consistent effect observed with TRYVIO 12.5 milligrams 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 events. As I mentioned at the beginning, I have no time 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 subgroups. Here, you may have seen this, this data that we have presented already.
The efficacy, the effect in the overall population is confirmed, and I would say sometimes amplified, in patients with moderate and CKD stage III, IIIA and IIIB, and severe CKD stage IV or chronic kidney disease, with decrease from baseline up to 11 mm Hg. This is on ambulatory blood pressure where you usually have less of an effect. But here, we have a 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 the in the USPI Section 5 , there is a starting wording that reflects, actually, the warning and precaution section that reflects 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 recognized by the FDA as adverse drug reactions is only the two that you see in the table: edema fluid retention and anemia, both well-known effects, especially anemia or hemodilution with endothelin receptor antagonists, 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 four weeks period. So it's from actually before the treatment.
You see that the vertical dotted line is the discriminator between pre-randomization, one where there was no aprocitentan, sorry to call it like this, and after randomization when TRYVIO was introduced. I would like also to remind that due to the study design, after four weeks, the patients were switched to 25 milligrams aprocitentan. You see that already before randomization, the incidence of edema is between 1%-4%. It's true that during the first two- eight weeks, you observe an increase to 9% in the first four weeks, coming down to 5% at week eight . After week eight , the incidence of edema is basically the baseline incidence. So very nice data on edema. But these are only the incidences.
As a reminder, I would just like to recap that 90%, over 90% of edema were peripheral leg edema, mild to moderate in nature, did not induce required discontinuation. Only 1% of patients, seven patients, discontinued the whole study due to edema. Additionally, this edema can, as also reflected in the USPI, can be treated with a short course of additional diuretics. Now, we have the final slide on REMS. Next slide. I'm also happy to share that we have what I would call an easy REMS for patients, physicians, and pharmacists. The only requirements are for prescriber to certify by means of the simple eight -question knowledge assessment. And also, the pharmacist needs 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 distinguishes this REMS from other REMS for other ERAs. And importantly, although the patients should be counseled taking contraceptive through the entire duration of the study, as mentioned in the 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 REMS. So I find that the REMS that we are able to negotiate is the easiest REMS compared to all other REMS, and not only among ERAs, but any other available REMS at this point.
With that, I would like to hand over to Tosh to next slide. Thank you.
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 non-fatal cardiovascular events, primarily strokes and MIs, myocardial infarctions. TRYVIO is the first oral antihypertensive tablet, which works via a new therapeutic pathway to be approved in almost 40 years. TRYVIO has just been approved by the 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.
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 the patient's blood pressure under control is very well established. We know that lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events. We also know that over 90% of these patients who are taking three or more hypertensive medications also have overlapping comorbidities. These patients have a two to six-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 three or fewer medicines. It is well documented that a five 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 eight million patients are immediately addressable with TRYVIO. To get to this eight 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 three medicines or they tried three 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 four+ medicines for their hypertension. This gets us to the approximate eight 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 three 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 of their cocktail of medicines. And potentially, a once-daily add-on medicine could be a viable alternative. But as I said, we have not focused on including this patient cohort in the eight million patient count. Next, another very important point is, yes, blood pressure treatments today, they are generic, but over 90% of these patients have comorbidities, including metabolic diseases such as diabetes, obesity, dyslipidemia. They have 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 comorbidities. Next slide, please.
When we look at the study population in our Phase III PRECISION study, once again, i.e., patients treated with three or more hypertensive medicines, we see that around 60% of these patient types are being treated by at least two or more physicians. Around 50%-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 on 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 PhaseIII PRECISION study. They view our blood pressure improvement on top of three or more hypertensive medicines as clinically meaningful. At the same time, they have their processes and SOPs, meaning TRYVIO will be accessible in 2024 and a good part of 2025 via the non-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 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 for January 2026 inclusion. Next slide, please.
So as I 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 that Alberto has 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 one-time physician and one-time pharmacist registration and certification. And there is no patient enrollment or patient registration requirement.
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 Clozel, our Chief Scientific Officer, let me finish by saying that at Idorsia, we look forward to making TRYVIO, 12.5 milligram once daily tablets, available in the US 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 non-fatal cardiovascular events, primarily strokes, MIs. Let me hand over to Martine, our CSO. Next slide, please.
Thank you very much, Tosh. With this landmark 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 indications. With all the information from the subgroups of patients which form the particularly severe population of the PRECISION study, the future is now open to the investigation of TRYVIO in additional large cardiovascular indications. Therefore, overall, big opportunities for our proceedings and going forward. And with that, I'll 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 are now ready to take questions from you. In terms of logistics, I only have two 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 that we'll be addressing questions on commercial success, operational costs, finance funding, and guidance at the financial call on the 25th of April. So keep your questions to Apro, please. Operator, please open the lines.
Thank you, dear participants. As a reminder, if you wish to ask a question, please press star one one on your telephone keypad and wait for a name to be announced. To withdraw a question, please press star one one again. Please stand by, but we'll compile the Q&A roster. This will take a few moments. Now we're going to take our first question. And it comes from Peter Verdult from Citi. Your line is open. Please ask your question.
Yeah, thank you. It's Peter Verdult, Citi. I'll stick to the rules even though I've got lots of questions.
But congratulations on the approval. The excitement at Idorsia 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, while it praised your trial design, one could characterize the editorial as lukewarm in terms of the aprocitentan proposition. Your former partner, a cardiovascular powerhouse, handed back the rights. You can't ignore that fact. And this data has been on the market or been 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 Idorsia for the drug and the opportunity you see with those observations because it's just working as 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 you know how the commercial success of that product played out. Thank you.
Okay. So thank you, Peter, for your question with a 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 it 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 this drug. It's not the first time they do it.
They did it with aprocitentan, which is close to sell it for $2 billion. And they gave it the drug back. And they bought it back for $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 just in was it in September? 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 am really not worried by the potential commercial success. It's a very different case from QUVIVIQ where we had with the question of scheduling some obstacle. And this scheduling was used by payers.
We do not have at all such a case. It's not at all to be within the generic market. So I think it's a very, very different situation. I am absolutely convinced that it's going to be a very big commercial success with or without a partner. We'll see. Tosh is assessing the best strategy for us. We will see how many patients, how many prescribers we need to contact. We will see what is the best strategy for us to continue.
Thank you. Thank you, Jean-Paul.
Can I give a word to Alberto here for the lukewarm editorial? I think what for me is more important is the feedback I got from the patients in the study and from the health authorities. I think the label that we just received translates well the value of this drug.
I think it's the patients that stay in the trial because we were estimating more patients to drop because all the experts, the famous experts that at the end write the editorials, say, "Oh, your study is 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, the vote of the patients that stayed in the study and the feedback of the health authorities as compared to some editorials.
Thank you, Alberto.
Thank you. Operator, next question, please.
Yes, of course. Just give me a moment. Now we're going to take over next question. And the question comes from the line of James Gordon from J.P. Morgan. Your line is open. Please ask your question.
Hello, James Gordon, J.P. Morgan. Thanks also taking this one. Yeah.
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 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 a bit till you find out 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 take 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.
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. Who was the prescriber? How many rep do you need? How many MSL do 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 also discuss with the payers. We can show them the label. It's not anymore an 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. We are not recruiting for the time being ourselves. We are evaluating the best strategy.
Thank you, Jean-Paul. Tosh, you want to add to that?
Yes. Andrew, yes, I can go ahead. Look, we just received FDA approval. For the moment, as Jean-Paul said, we are clearly evaluating the best options for the launch itself. We're evaluating all options, including sales force sizing, sales force deployment. Look, we plan to make the drug available later in the year. But at the same time, we're getting ready for launch. We are engaging with payers. We're continuing to conduct our market research and key opinion leader engagements. We're building out the REMS platform. We're also establishing our distribution channel.
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. All this work will be done in the coming weeks and months.
Thank you, Tosh. Operator, next question, please.
Yes, of course. Now we're going to take over next question. The next question comes from the line of Laura Pieper from Octavian. Your line is open. Please ask your question.
Yes, hello. Good afternoon. 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 you know 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?
Well, 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 are 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 with that, let's see and wait. But I'm quite confident at this point.
Thank you, Alberto. Operator, next question, please.
Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad. Dear speakers, just give us a moment.
Now we're going to take over next question. And the question comes from the line of Peter Verdult from Citi. Your line is open. Please ask your question.
Yeah, thanks, Peter Verdult, Citi. Just a follow-up maybe for Tosh and a clarification. Anything you're willing to say right now in terms of price point as it relates to the US market? And I don't quite understand evaluating all options. I thought the situation with Idorsia is that you were 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 just to clarify, I realize we're not talking we'll talk about corporate stuff in April. But as it relates to aprocitentan, just I want to understand, evaluating all options, do you believe you have the resources to fund the launch on your own?
Are you willing to weigh in on the price point or likely price point you're seeking in the U.S.? Okay.
Thank you, Peter. Tosh, do you want to take the pricing question? Then we'll take the strategy question to Jean-Paul, please.
That makes sense. Yeah, Peter, thank you for your question. The WAC price, the wholesaler acquisition cost or list price, we intend to publish that in the coming weeks.
Jean-Paul?
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. Some other things are, of course, cooking.
So I think that we absolutely want to be in a situation to 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 or with TRYVIO. And we have the chance here to have an organization in place in the US 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 US. 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 US.
Thank you, Jean-Paul. Operator, next question, please.
Thank you. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad. Let's give us a second for all our participants to press star one one if they wish to ask a question. And now we're going to take a next question. And the question comes from the line of Laura Pieper from Octavian. Your line is open. Please ask your question.
Yes, hello. Also just a short follow-up. So do you plan to conduct further clinical studies now after approval?
Sorry, Alberto.
Yeah, I say because I would love. And I think that there is a huge potential. And 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 let Jean-Paul ask.
But of course, and this is one of the aspects that we have to discuss with a potential partner. Is the partner going to develop to go with the other indications? This was a plan 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 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.
Thank you, Jean-Paul. Thank you, Alberto. Operator, next question, please.
Yes, of course. Now we're going to take our next question. And the question comes from the line of Suzanne van Voorthuizen from Van Lanschot Kempen. Your line is open. Please ask your question.
Yeah. Thank you for taking my question. 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, that's my question. Thank you.
So yeah, if I understand well, you are asking, do we have the people to do that? And do we have the capacity? And I just mentioned maybe you could not because your line was closed. But as I say, 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 have heard that they say, "Oh, 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 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 of course, we are very aware of the financial situations.
We are working on that. 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 two big Phase III to spend money on. This gives us a lot of more flexibility for our future decision.
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. We have 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 said before, before your results on first quarter 2024 results on the 25th of April, where we'll be giving more data on financial performance and guidance.
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.