Good morning. I'm James Gordon, J.P. Morgan, European Pharma and Biotech Analyst, and today I've got the pleasure of introducing the Idorsia presentation. We're going to hear from Idorsia's CEO, Jean-Paul Clozel. Thanks very much for joining us today, and I look forward to the presentation. Thank you.
Thank you. So, the sound is okay? Good. Okay. So, I just would like to explain, you know, the situation of Idorsia today, because I have been in the business for quite a long time, but this is a situation where on one side, we have very fantastic products, very innovative, some on the market or close to be on the market, and on the other side, we have limited financing. And what I'm trying to explain to you is how we are going to do in order to solve this issue. So what we really want is to create a sustainable company, which means a company with a marketing organization, with a research and a organization, with a pipeline, and frankly, a company based on innovation.
So first thing is that last year, when we were at J.P. Morgan, we were just starting the launch of QUVIVIQ in insomnia. And QUVIVIQ, I have to say, is the ideal drug for insomnia because of its pharmacokinetics. Not only the drug is absorbed very fast, so you really can improve the time to sleep, but also it has a short half-life, and it does not accumulate. And you can see on this slide, this absence of accumulation, which is very important. But it is long enough, and that was why we spent so many years in order to discover this drug. It was long enough to be able to work during the second part of the night.
It is after three or four hours in the morning when people wake up and when they start not to be able to sleep again. And as you can see, for example, if you compare, this was a phase II, zolpidem in, in green, you see that zolpidem, you have a better sleep or less, awakening at the beginning of the night. But in the second half of the night, you see that it doesn't work anymore. In contrast, in blue, you see that QUVIVIQ continue to work, and despite this very, I would say, reasonable duration of action, you do not have, sleepiness in the morning. This combination of this property has been the key for, QUVIVIQ. Now we have launched in, many countries, not only the U.S., but also in Europe, in Italy.
And here you see a study in real life, in patients, in Italy, and you see that what we have seen last year, I show you the IDSIQ results, which were our PRO or Patient Reported Outcome study, showing that not only you improve the insomnia symptom, but also the depression syndromes, the maniac syndrome, and the anxiety symptoms that you can see in this patient. And this is a real-life study performed in patients from a psychiatrist in Italy. So now, where is the US launch? Where is— We have treated now more than 125,000 patients, 300,000 prescriptions have been dispensed, and we have really reached 35,000 prescribers.
So the start of the launch, this is where we were last year, was really a DTC campaign, because our strategy was to really create a brand, which we did with many activities, which have created a recognition of QUVIVIQ as a brand. But the problem has been, and that's something which we maybe did not anticipate as we should have done, but the market access was tougher than we were thinking. But during the year, we have been able to improve this market access. And starting from basically one year, zero market access, we now have in the commercial sector about 62% market access, and we start now to Medicare to have a 10%-20% market access.
So that's very important because at the beginning, we were dispensing drugs, but we were the patients were not reimbursed, and we had to compensate for that. So at the beginning, and then you can see, most of the prescription were for free, but now that's November data. I do not have here the December data. More than 60% of the prescription are paid prescription. So we still lose some prescription because the payers for prior authorization are still creating some obstacles, but we have a much better payer performance. And the one thing that we really underestimated also was the importance of the scheduling.
I think especially after the opioid crisis, scheduling has had a bigger impact than we thought, and really creating some obstacle for the doctors, you know, in some we cannot sample. There are a lot of rules related to scheduling. And of course, also the payers have used this scheduling, which is the same as a very addictive drug, such as benzodiazepine. This has been used by some payers for prior authorization. So some payers are asking that patients are put under benzodiazepine before they use our drug. So getting an addictive drug before getting a non-addictive drug.
This is why we have made a citizen petition, and this citizen petition should lead to the descheduling, and we are really, really very confident that at one time point, QUVIVIQ will be descheduled. The other thing that we did, and I am very happy that Tosh and is here, we have changed the management. We have really brought in Tosh with the idea of creating a different culture, which is to really achieve same or better results, but with less cost, with less financial constraint. Now, of course, the situation in Europe is quite different. In Europe, there is no other orexin receptor antagonist than QUVIVIQ.
And you know, in Europe, e verybody was thinking, was telling us, "You will never get reimbursed. It will never get a price." And in fact, what we have seen as, for example, in Germany, is they changed the law. The government has changed the law, which was restricting reimbursement of any sleep drug for four weeks. And what we have seen that they have changed the law. Now, QUVIVIQ is the only drug reimbursed chronically for insomnia. There is no other one. In U.K., even if NICE is known to be quite tough, we got a good price. We get reimbursement. In France also, we got with a good ASMR or medical service, we got a good reimbursement, a good price, and we are going to launch very soon in France. We just have launched at the end of the year in U.K.
In Italy, no drug is reimbursed, has ever been reimbursed for sleep, but we are in discussion, and I think that the Italian government is also ready to consider reimbursement of QUVIVIQ, knowing the advantages and the lack of addiction. In Switzerland and in Spain, we have launched by self-pay and with very good results. In Switzerland, many patients now are treated chronically with QUVIVIQ. And in Canada also, for the moment, it is a private market which is addressed. And we have been able in Europe to really discuss and show the results to the experts.
Now, QUVIVIQ has a very key position into the European, into the European guidelines for insomnia, which is also very helpful, and it's also helpful in our discussion with, the payers in the countries. So now we have, been able to distribute, 11 million tablets. This is just the start. We have a long patent life. Long, it's always too short, but still we have about 13-14 years of patent life. And, really, we are going to be able not only to see an increase of the sales numbers, but we are considering line extension activities. We are doing a pediatric program. We are doing studies in patient with nocturia. So there are a lot of news which are going to come in the, next years. So that was, QUVIVIQ.
Now, aprocitentan. You know that, aprocitentan has been, tested, and the clinical trials were done in resistant hypertension. It's going to be, and, hopefully the drug is going to be approved soon. It's going to be the first new mechanism of action in hypertension for 30 years. It's unbelievable, but it's like that. Since 30 years, there was no, research on a new mechanism of dealing with, severe patients or even less severe patients. These are the results of the. This is the main, the primary endpoint. So there were two part of the study. First part is four weeks with two doses, where we see a big, fifteen millimeters, pressure decrease, but a placebo effect that you can see, when it's office-based.
It was when the patient was measured his blood pressure in the doctor's office. You see that this placebo effect is much less, of course, in the second part of the study, which was after eight months. We do the randomized withdrawal to show, and this was as discussed with the FDA, to show that the drug was still active. If you now use a much more precise method, which is ambulatory at-home measurements with an automatic measurement system, which measures every 10 minutes, I think, the blood pressure, you see that there is a major blood pressure effect. This confirms the primary endpoint, and this is even very marked during the night.
You know that the best predictor for morbidity, mortality is the nighttime blood pressure measurements by measured by ambulatory blood pressure monitoring. The side effects were really very, I would say, really nothing worrying. The only real side effect is really, I would say leg edema, edema of that we can observe. What is very interesting is that this edema first can be reduced if you make a dose titration. If you start in blue, 12.5 mg, and you go to 25, you have half of this edema because the body has time to really adapt. As you can see, the incidence of this edema is only there during the first two months.
After two or three months, there is no more, I would say, new edema, and frankly, for the patient yearly for life, doesn't have more edema than in the baseline because these patients, we must not forget, are very severe patients with renal failure, with heart failure. So you can see that, if you look at the prevalence of this edema, you can see this is higher with 25, starting 25 in red compared to blue, directly. But after these first two months, this is basically as much as the baseline levels, which is shown in gray at the right, which is basically the baseline in this patient because they are treated with a drug like amlodipine, high dose of amlodipine, which is by itself inducing edema and leg edema.
Now, what is really fantastic, and it's very impressive, if you look at patients with chronic kidney disease, you see that the blood pressure effect, especially during the night, is major. 12 mm of mercury, and here the placebo effect is much smaller. If you look to very severe patient, and you know, we can treat severe patient because there is no hyperkalemia like you can have with aldosterone synthesis or aldosterone receptor antagonist. We do not see hyperkalemia as a problem. You see minus fifteen millimeter blood pressure effect, major effect in chronic kidney disease. Now, let's go to another very innovative product, is selatogrel. As you know, today, when you have an acute myocardial infarction, and you really have a big risk to have a second one.
What I would observe as myself as when I used to see patients with infarction is that since ever patients who have a second myocardial infarction really lose many hours in order to be treated because they are at home. They need to call the doctor. It depends on the systems, but I know that in many countries, like in the U.S., you do not have doctors within the ambulance. Sometimes you have it in some countries like France. But basically, the average time is three to four hours, where you get your infarction, the second infarction, and you are not treated until you go to the hospital.
I said, if we could find a drug which would really be able to be given in this patient and could act immediately, if they can be auto injected by the patient, by themself, we will save three or four hours of treatment time, and this is during the first hours that the heart is damaged. After three or four hours, you can do, you can put tPA, you can do many things, but you are not going to save myocardium. And we have had this auto-injector, which has been developed in with Halozyme, and now the treatment, which we think will be the future treatment of this patient, is that they get pain like they have had the first time they get the myocardial infarction.
They inject themselves with the selatogrel, then they call the ambulance or the doctors, and they go to the hospital. But during all this time, until they are on the angioplasty room or within the ICU bed, they have been under treatment of a high dose of antiaggregant, antiplatelet agent, and we choose clopidogrel as a very safe, very, it's a, it's a different anti-aggregant, which works very quickly, subcutaneously, as you can see here, very fast platelet aggregation inhibition. And then it starts to recover, so that after four to six hours, basically there is no more risk of being able to combine it with any other treatment or to make an angioplasty. You do not have this risk of bleeding.
And I can tell you that we have treated more than 5,000 patients without any sign of side effects or bleeding. Now, the big question I had is that, are the patients going to really inject themselves? Will they do it for the right things or or and will they do it quickly? Because if they wait for two hours before they inject themselves, we have really no interest of this type of treatment. And I can tell you that I was very surprised, but the patients do it really for the good reasons. It's not if they have a migraine, they are not going to inject themselves for most of the patients, and they do it very quickly, within 15 minutes on average.
So really, I think we are going to see a major effect, and we are going to save life. I really think so. We are going to prevent a lot of heart failure and cost for society. Just I mentioned that. Now, we have cenerimod. And cenerimod, the very interesting thing with cenerimod is this S1P, a sort of a very interesting molecule. But when you think of the mechanism of lupus and how cenerimod works, you realize that cenerimod is the ideal treatment for lupus because it prevents the migration of the T cells and B cells into the joint, into the target organ. But it also prevents the exposure of these target organs to a lymphocyte presenting the antigen. This is what we have seen.
So really, we are dealing. And we are also preventing the formation and the synthesis of cytokines, which are also playing, like interferon, playing a key role. So we have three mechanisms of action, which really are explaining why we have seen, especially with the dose where all these effects can be observed, 4 mg, a very marked effect on disease activity, SLEDAI here, and this effect is really increased in severe patients. And severities can be measured by complement measurements or anti-DNA measurements, and you see that the more severe the patient, the bigger the effect. And really what you see is that the effect is building with time, so it's not a placebo effect where you have parallel curves. Here you see that the effect builds months after months. So that was cenerimod.
I don't have time to go to the rest of our portfolio. We are now, in fact, you know, selecting the most important because we had the chance, and it's even more frustrating because of our financial situation. But we have many more products and e specially we found new vaccines, and but we are looking for partnering most of these earlier assets and maybe keep one or two assets for the future. So that was the assets. Now, the financial situation, we are in a difficult situation. We have money, let's be clear, until beginning of April, and we have done many things to solve this issue. First, we have really sold, to so say, the Japan and South Korea organization.
We have reduced the number of people, the workforce, we have adapted the portfolio, and we are looking for partnership in order to really decrease on one side, our research, R&D costs, but also find some financing for the future, and I'm quite confident that we are going to achieve that. So really, I hope I can explain to you what we are trying to do is really to fund the company without selling everything, but retaining shareholder value within the company. It's not easy, but we are going to do that in 2024. Thank you very much.
Thank you very much. With the presentation done, we're now open for Q&A. Does anyone in the room have a question they'd like to ask him? In that case, I'll start us off with a question, which would be of the different funding options, in terms of assets that you might divest, which do you see as most likely?
You know, I have a CFO here, André, and so maybe you can answer.
If you could maybe wait for the microphone, it's just going to come to you.
Can I get a mic? Yeah, well, we made it publicly several times. We have several balls in the air, so we'll catch, hopefully, one or a string of these deals in the next few months. As Jean-Paul said, we see a Sosei deal mid-July last year. We extend the cash runway until early April. So, we need to get a deal done in the meantime. Beauty of having this rich pipeline, mainly fully and I would say almost fully unencumbered, is that we have different ways to different assets to partner and trying to maximize the value for these partners. Doesn't mean that we would exclude the equity or equity-linked route. As you know, we have some debt on our balance sheet, notably with two convertibles. One of CHF 200 million maturing in July 2024.
The other one is further out, 2028, even if the investors have a put option in 2026. So any equity would need to be combined with a restructuring also of the convertible. But the real inflection point and the real source of immediate funding, unfortunately, because the stock price is so low. And I'm not speaking even of a dilution. You would not have any investors willing to inject money if it's to repay some bondholders. So we need to have one or string of BD deals with upfront, also relieving some drain on the cash flow with potential clinical assets.
And then, think more broadly, in order to be funded beyond—extend significantly the cash runway. Many balls in the air. We need to catch one or a few of these to extend the cash runway.
Thank you. And if I could ask a follow-up question on that perhaps, which would be for aprocitentan, since you got the rights returned to you, have you had new discussions with anyone? And is that potentially divestible or partnerable before the approval decision, or would you probably need to wait to see the approval decision?
In my experience, you know, it's very difficult for any partner to partner a few days before an approval because, you know, why not wait one or two more weeks and to have clarity on everything? So it's I would say it's not so easy to make a deal, but the question is more, you know, what are we going to do? Because we want to retain some also some products, some chance to really see our sales increasing, becoming profitable, and becoming sustainable. So do we do it on our own? Do we do it with a partner? Do we do it, do we share, you know, for example, the efforts? So this is what we are evaluating.
We have the chance to have Tosh, who is now the General Manager or President in the U.S. organization. He has had a very large experience in cardiovascular within AstraZeneca, and he has launched many drugs. He was, I think, in MyoKardia as. So he knows exactly. And what I said, the most important, the most important thing is to really create a culture of having a startup, you know, to do a lot of things without spending and without cost. So I think that we are evaluating it. We just got it back from September, you know, from Johnson & Johnson. So we were not allowed, we did not have the possibility to discuss with potential partners before Johnson & Johnson release us. And I think that there are many options.
What is sure is that aprocitentan has no competitor, is the first drug for difficult-to-treat hypertension. I don't think there will be competitor for three or four years. We are going to be in a very fulfilling a very big medical need, because frankly, here and the WHO and the FDA recognize it, hypertension, resistant hypertension is the number one addressable cause or burden of medical burden, and one of the priority for the WHO in order to prevent what is happening and which we didn't have 20 years ago. You know, you never saw a young woman with stroke. Today, this resistant hypertension, this very severe hypertension, which is associated with diabetes, with obesity, with hypercholesterolemia, this is a killer.
I am very proud that, within Idorsia, we brought a product to address this medical need.
Are you preparing to do a launch yourself? So if you were able to solve the funding problems via other assets, would you potentially do the launch yourself?
I think we, the team with Tosh, and maybe you, Tosh, you can tell what is the situation of the U.S. organization, I think, yeah.
Thank you very much. So look, the PDUFA date is on March 19th, so it's imminent. And given that situation that André has mentioned, our CFO, of many balls up in the air, we are in parallel preparing for a U.S. launch to go ourselves. Clearly, that's subject to André and Jean-Paul securing the necessary funding. But the team's in place, the plans are in place. Clearly, there's a lot to do because we acquired the drug, reacquired it back from J&J the week I joined the company in September. So we're behind where we need to be, but we've got a good team. They know cardiovascular. We've got a, I believe, incredible medicine, pending approval by the FDA. Huge unmet need, resistant hypertension.
We've got a unique mode of action, a four to five runway ahead of the competition, who are doubling down on the existing aldosterone pathway. So we're excited about that. Our development program hasn't shied away from those patients at the greatest amount of unmet medical need, i.e., CKD patients, in addition to general patients. The drugs that are coming four or five years down the line, they've shied away from the CKD patients because they're difficult to treat, they're more fragile, and there's a risk of hyperkalemia when you double down on the aldosterone pathway. So we don't have that baggage. So for many reasons, we would like to be a part of commercializing this drug in the U.S.
We think it's got huge potential to address patient need, huge potential to play a part in addressing the enormous healthcare costs that these, this patient cohort is costing the U.S. healthcare ecosystem. But we're open to any type of deal construct, but I would, I and we would like to partner with another organization, because we recognize the resources to get to the entire market are quite substantial. So if we have to go it alone, the reason why we're confident we can do a great job and prepare for the future is we want to launch it in the U.S. ourselves. If we, if that's what we have to do, and we're prepared to do, we'll establish a really focused beachhead, a landing point, where there's huge unmet need. I've already hinted at that with CKD.
That cost a huge amount of dollars to the American healthcare system. We believe we're an organization that can do that, establish a proof of concept, and then ourselves or with another partner, we have the opportunity to go broader into the broader resistant hypertension population, which is significant. That's the situation we're in.
Thank you, To sh. So as we know, as you see, we are very, very excited. Again, we are not going to launch it in the GP. It's not a sleep, it's not a sleep drug. It's a very active product, very powerful. It's not difficult to use. It's very easy to use, in fact, but we will only concentrate, if we do, on specialists, hypertension specialists, the, the hypertension centers and nephrologists, the cardiologists. We are not going to go to the GP for many, many years. But I think that when people will be using this drug for many years, the specialists will, will know that. I think at one stage, maybe we can expand this market, and we, we will need a, a big, a big guy in order to do that. But this is not for the first two or three years.
This is not our intention.
Thank you. And what about QUVIVIQ? As in, is this a product that you would potentially partner or even divest? It's your most de-risked product, or is that sacred, and that's one you'd have to do yourself?
It's a difficult. I don't know how to answer that because when you... In Europe, it's going to be. Maybe one day we'll show you the curve when it's time, but there is a takeoff. In Europe, it's really, it's going to be very successful. We are only one. This is really, Europeans are very afraid of Benzo, of Ambien, of these drugs. So in Europe, I think we are on good track. So that's i n the U.S., I think we can really decrease our cost, decrease our efforts to try to slowly grow, but in a slow growth until we get the scheduling.
If you look at what happened when there was a black box on Ambien and the trazodone replaced Ambien, you know, we, we are now speaking about getting 1% or 2% of the market to this is orexin, this is Idorsia. You know, what we are having, trazodone is 50% of the market, 25 more, and it's not even indicated, but it's not scheduled. The difference is scheduling. So we can really maybe wait one or two years until we first get a better financing, but certainly get the scheduling. I would not put huge financial efforts on QUVIVIQ until we get the scheduling.
Great. Thank you very much. I think we should probably wrap it up there then. In that case, thank you very much.
Thank you. Thank you very much.