Thank you for standing by. Welcome to the Idorsia full year 2023 and first quarter 2024 financial results webcast and 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.
Thank you, Nadia. Good afternoon, good morning to you all. This is Andrew Weiss, and I want to welcome everyone to our webcast conference call to finally discuss the full year 2023 and first quarter 2024 results with you. As you may have noticed today, we've also filled your email box with other report, important releases regarding governance structure at Idorsia. I will shortly hand over to our CEO, Jean-Paul Clozel, and our CFO, André C. Muller, to give you additional color on everything we've announced today. Then, joining us for the Q&A session, we have our General Manager and President of the U.S. organization, Tosh Butt, and our soon to be President of Idorsia, U.K. region, Benjamin Li, who will be taking over from Jean-Yves Châtelain. Next slide, please. Before handing over the microphone, I need to remind everyone that we will be making forward-looking statements today.
You have therefore been appropriately warned about the risks and opportunities of investing in Idorsia shares. With that, Jean-Paul, the floor is yours. Next slide.
Thank you, Andrew, and, after 24 years, this is going to be my last webcast as a CEO. I think it's a good time to really think of what we have achieved, since the creation seven years ago of Idorsia. We did quite a lot. Since we brought three drugs to the market, PIVLAZ, QUVIVIQ, and TRYVIO. Also, during this time, we built a global marketing organization in the US, in the main country, in Europe, and also in Japan. Of course, we launched QUVIVIQ in the US and in the main European countries. We created, in addition to these three products, which went on the market, a late-stage pipeline, and we continued to discover new drugs and build a very strong pipeline.
We also reacquired the rights of aprocitentan from Johnson & Johnson, and of course, all that required funding, and we have been able, up to now, to pay for all these achievements. Next slide. So we are not stopping to work, and there is still a lot to do, and I would like to focus on what we need to achieve until the end of this year. First, we have to continue to increase the sales of QUVIVIQ, and you will see that in Europe the launch in the different countries is going on very well, and we will see strong growth for QUVIVIQ.
We need to prepare for the launch of TRYVIO in the US, and we need also to continue to innovate, because new products is going to be key for also for the future of Idorsia. And clearly, André will speak about that, we need to extend the cash runway, since we have been able to find a solution for delaying by six months the convertible redemption. Next slide. So I think that Idorsia, with all these achievements, with this clear objective, is entering into a new phase. And the goal, the final goal, has never changed. We want to reach financial sustainability as soon as possible, and this is why it's so important for us to increase our revenues from partnership and also clearly from our marketed products sales.
Next slide. For this next phase, we are strengthening and increasing the executive committee. Julien Gander, the General Counsel, is going to join, as well as Arno Groenewoud. We will replace André as the Chief Financial Officer. Martine and Alberto are staying as respectively Chief Scientific Officer and Head of Clinical Development. So, we have also, as mentioned in our press release, I will be candidate to be elected as Chairman of the Board as the next AGM, with Matthew continuing to be serving the board of Idorsia as the Vice Chairman, and he will be candidate to become Vice Chairman and Lead Independent Director.
We have Bart Filius, who is going to be a candidate for joining the board, with also where Sophie Kornowski.
Srishti.
Srishti Gupta will remain.
And Sandy.
and Sandy Mahatme as the Head of the Finance and Audit Committee. So with these changes, I think we are going to be very well equipped for a bright future. And André is going to describe a little bit, not only the year 2023, but also what we intend to do in 2024.
Thank you, Jean-Paul. Let's go to see a next slide, slide 7. As you can see, and Jean-Paul alluded to it, the last few quarters have been quite busy across the organization for Idorsia. I take it in a sequential order. Mid-July 2023, we closed the CHF 400 million deal with Sosei Heptares . Now, a new brand name is Nxera Pharma. In September, we reacquired the worldwide rights of aprocitentan from Janssen for conditional consideration up to CHF 306 million. In Q3 2023, we also launched a cost saving initiative, mainly with the R&D and support function, but also with a new priority for the commercial organization.
Of course, the early stage pipeline was also prioritized. Moving to 2024, we closed the transaction with Viatris of $350 million regarding two of our phase III assets, selatogrel and cenerimod. And last in May, so early in May 2024, we also restructured the 2024 bonds. It remains subject to the final approval of the Swiss cantonal authorities. But now, as Jean-Paul said, the CHF 200 million bond will mature at the latest mid-January 2025.
So, that's, as you can see, a lot of work achieved, in the last few quarters, and a lot of work behind the scene, I would say, on the, business and development, front, with an objective, a clear objective to extend the cash runway and also, of course, maximize the value of the assets liable to be a potential partner. Next slide, please. On this slide number eight, you can, you can see, the, the, full year 2023 numbers. Not entirely, new, to you, as we published in Ap- in, April 2024, the financial status in connection with the, CD, con- convertible bond, restructuring, which also included the Q4.
It was easy for you make the math with the nine months plus the last three months to figure out what was the performance for the full year 2023. With this new format, actually, we'll allow to understand the performance between the Idorsia business, which is operated by us, and the partnered business. So with assets partnered or and/or operated by your third parties, for which we will of course keep upside with with potential milestones and royalties. If you look at 2023 on the left side, you have the reported numbers.
On the right side, you have what we call the pro forma numbers, which excludes the impact of the sale of the Asian business, ex-China, to Nxera Pharma. For as you can see here, that's an impact forces a specific deal in the P&L of CHF 368 million. The rest of the contract revenue 19 would actually equal the CHF 387 million that you can see on the partnered business. Regarding the Idorsia business for 2023, you see little difference between reported and the pro forma. Because the contribution of our operation in Japan and South Korea for the six and a half months that we operated the business before the Nxera deal was minimal.
You see that we ended with non-GAAP EBIT loss of CHF 592 million. So roughly CHF 329 million for commercial and CHF 262 million for R&D. The next slide, please. So slide number 9, I will not spend too much time on the quarterly development of the Idorsia business. So also excluding, as we discussed, the Nxera deal and the 6.5 months operation in Japan and South Korea. But what you can see is over time, we use loss following a new commercial strategy. We'll discuss it in the next few slides. And the initial benefits of the restructuring and the portfolio prioritization.
R&D, as you can see, of CHF 262 million in 2023, of course, included the study cost for selatogrel and selinexor. Without this, we would have been slightly below CHF 200 million. Next slide, please. Liquidity or cash development. Cash went down to CHF 145 million by year-end, despite the much needed cash from the deal with Nxera Pharma for CHF 400 million. Next slide, please. Now, switching to Q1 2024. Again, numbers already disclosed with the financial status published in April, in connection with the restructuring of the convertible bonds. Let's start with the apartment business.
You see the impact of the Viatris deal. As you know, we receive an upfront of $350 million. Only $150 million, ending with some slight, a small adjustment to CHF 125 million were accounted and recognized in the P&L. The reason for it is that the remaining $200 million represent the commitment of Idorsia to fund the phase III cost for selatogrel and cenerimod. Above $200 million, it will be Viatris who will fully cover these development costs.
And it means also that this $200 million will be recognized over time, not as a contract revenue, but as a deduction of the R&D costs. And this started already in Q1 2024, with $14 million recognized in the P&L as a deduction of the R&D costs. Now, looking at the Idorsia business. You can see here a very clear impact of the cost-saving initiative in Q3 2023, with much lower SG&A, despite an increase in U.K., we'll cover it in the next few slides, and much lower R&D OpEx.
The 29 million OpEx in R&D compares actually not to 80 million, but to a 65 when you exclude, when you exclude the selatogrel and selinexor costs incurred in Q1 2023. Next slide, please. On this slide 12, again, you see the same cash development for the first quarter of 2024. You see that we see a cash and the cash equivalents by the end of March is 335 million Swiss francs. Of course, helped with the $350 million, i.e., 308 million Swiss francs Viatris deal. Next slide, please. Slide 13. Here you see the announcement regarding apalutamide in the U.S. and in Europe.
Speaking of the US, 12.5 milligram was approved on the nineteenth of March by the FDA under the brand name TRYVIO. As already mentioned in the previous webcast regarding this approval, TRYVIO is the first oral anti-hypertensive tablet, which works via a new therapeutic pathway, and to be approved almost in the last 40 years. Indication in the US is for the treatment of hypertension in combination with other hypertensive medications to lower blood pressure in patients who are not adequately controlled on other drugs. So it's for us, and I hope for the community, a significant medical breakthrough in the field of hypertension and blood pressure control.
In the month of April 2024, the EMA, European Medicines Agency, Committee for Medicinal Products for Human Use, so the CHMP, has issued a positive opinion on aprocitentan under the brand name JERAYGO. Recommending a marketing authorization for the treatment of resistant hypertension in adults, in combination with at least three antihypertensive medicines. Here it should be 12.5 and 25 milligrams that should be approved. Moving to the next slide, to slide 14. You see how we now prepare the launch of TRYVIO in the US.
As you know, and as we mentioned, a little time since we reacquired the rights from Janssen back in September 2023. In short, we can say that we want to make TRYVIO commercially available in the fourth quarter of 2024, and have a commercial launch in the first quarter of 2025. We announce by the end of April, our monthly WAC of $775. The launch readiness is underway, and this includes building our reps program, establishing the distribution network, initiating the process of holding post-approval clinical reviews with the payers.
This will continue throughout the remainder of the year, and of course, moving forward in 2025. We've also made progress in the hiring and training of our medical science liaison, because HCP need to understand the unique benefits of aprocitentan. And as the US team could interact with many cardiologists at the American College of Cardiology in April, US team will continue the efforts with three upcoming important congress, AHA/HCN in Boston in September, AF and Kidney Week in San Diego in October, and AHA in Chicago in November.
And, again, the full commercial launch is targeted with an initial salesforce deployments for early 2025. Next slide, please. Speaking of the U.S. performance, on the left-hand side, you see the quarterly evolution of the prescription of QUVIVIQ since the launch. On the right-hand side of this slide, you see a salesforce number, which has decreased since the launch, as you can see. And, this is part, we mentioned it, the refocused strategy in the U.S.
While we are working, we'll discuss it on the citizen petition to get the drug schedule. Currently, we were able to deliver robust volume growth in prescription in the first four quarters after launch. And this was despite the sales rep numbers decreasing, as we sought to better manage our OpEx in the U.S. affiliate. If you take the total prescription volume around 60,000 prescription per quarter for the last 2 quarters, and again, despite the reduction in sales rep numbers.
Now, speaking of sales force, we rightsize the sales force to 100 reps, and we feel this is now the right number as at this time, based on the access we have and our Schedule IV status. Speaking of access, no change in Part D coverage, which sits more or less at 26% with UHC, Optum. Our commercial coverage is now around 65% with ESI, CVS, and some of the Blue plans. In addition, I would say, we are encouraged to see that the 50 mg dose represents more or less than three quarters of the volumes.
Sustaining this ratio is very important because we see a greater efficacy and improve adherence with 50 milligrams compared to the 25 milligrams. Next slide, please. From slide 16, you see the proportion of payer mix, paid prescriptions, which is now 73% by the end of March 2024. So improving over the quarter-over-quarter. And at the same time, we continue to reduce our reliance on the consignment slash free goods, which you can see in the blue and red color bar. Next slide, please.
So here, you see, the sales development in the US in Swiss francs. So, with CHF 6.5 million in Q1. So if you take the main numbers beyond the sales, since the launch, more than 140,000 patients have been treated with QUVIVIQ. More than, or close to 400,000 prescription have been dispensed, and the product has been prescribed by more than 42,000 HCPs. Next slide, please. I already mentioned it, that's for us, a key milestone to unlock value for QUVIVIQ in the US.
We filed in April 2023 a citizen petition urging the FDA to deschedule the dual orexin receptor antagonist class of chronic insomnia medication. This, of course, is based on a review of evidence from available data, including post-marketing surveillance data. Starting in 2015, the independent FDA approval of other DORAs included the recommendations that these drugs be scheduled based on the preclinical data. The citizen petition to deschedule the DORA class outlines current scientific and medical evidence demonstrating that the DORA class has a negligible abuse profile and potential for abuse, lacks non-medical use in the community, lacks physical and psychological dependence, and there should not be a scheduled class under the Controlled Substance Act.
EMA and FDA acknowledge that this CP, which is the first step. The process to analyze and examine the request is moving forward. Those will be a report combining the FDA appropriation bills was finalized in March 2024, and informed that the process for descheduling the DORA class is a priority for Congress. So progressing, and we do not know if we will achieve it. We are reasonably confident. And regarding the timelines, we are depending on this process. But again, key for the U.S. organization to unlock the value for Q8. Next slide, please.
So switching to Europe and Canada, where we made also great strides. On this slide 19, you see the developments of the volumes. Here we show a number of pills growing to more than 1.5 million in Q1 2024. And this, of course, with a staggered launch across the UK and the region, expanding the availability to more markets and also advancing, well, on the reimbursement fronts. Starting with the key countries.
In Germany, the G-BA lifted the four-week prescription limitation for QUVIVIQ in November 2023, which makes QUVIVIQ the only sleep medication that can be prescribed for long-term treatment of chronic insomnia.... and this decision has a direct impact on renewal of prescriptions. In parallel, in December 2023, the price was negotiated for QUVIVIQ under the AMNOG process, and became effective by the end of 2023. And this has also a positive impact on the level of prescriptions, especially with GPs. But we see it in the next slide, we had also a negative impact on the net sales.
Out of the 978,564 pills can be ascribed to Germany. Out of the 1,540,912 could be ascribed to QUVIVIQ in Germany. So you see a clear uptake in the volumes for QUVIVIQ in Germany. Going to the UK. NICE in October 2023 and SMC, so the Scottish Medicines Consortium in April 2024 recommend now QUVIVIQ as first-line pharmaceutical treatment for patients with chronic insomnia, after or as an alternative, CBTI.
By end of Q1, I'd also have access in roughly two-thirds of regional ICBs, Integrated Care Boards in England and Wales, and this number will continue to grow. To our knowledge, this is unprecedented for primary care drug. Going to France. You see, QUVIVIQ was launched at the end of March, and as the first and only pharmacotherapy recommended for the treatment of chronic insomnia disorders. Following the announcement in January 2024 in the French Official Gazette of the inclusion of QUVIVIQ in the formal list of reimbursed pharmaceutical specialty, together with the French public price, which was published as 164 EUR per tablet.
Keep in mind that the French insomnia market is the second in Europe in terms of potential, and here we—you have now unlimited reimbursements for QUVIVIQ. We also launch in other countries, but in the self-pay market. This was the case in Canada, where we launched it in November 2023. We achieved so far around 57% coverage of the private Canadian lives by the end of Q1, and which this private market represents roughly 50%-55% of the total Canadian insomnia market. Sales force was developed, deployed by the end of January, and we are also working on the submission of QUVIVIQ to the public Canadian payers.
A possible decision could come by the end of this year. In Italy, it was also launched in the self-pay market in November 2022 with a specialist, psychiatrist and a neurologist, which represent around 20% of the total insomnia market. We also submitted a reimbursement dossier mid-2023, and we also requested the expansion of the prescriber base from specialists to a GPs with, again, a possible decision in the course of the second half of this year. Spain, we launched in the self-pay market again in September 2023. We are assessing the opportunity to submit a reimbursement dossier to the local authorities.
Switzerland is the home country. QUVIVIQ was launched in June 2023, and we hope to get QUVIVIQ added to the specialty list in the next few months. Last but not least, the new European Insomnia Guidelines published in the Journal of Sleep Research in November 2023 included the QUVIVIQ. The authors noted that I quote, "The introduction of the DORAs has probably been the most significant recent development in the pharmacological treatment of insomnia." Needless to recall you that daridorexant is the only DORA approved in Europe. Next slide. Here you see the sales numbers since launch, which is a staggered launch across the UK and region.
Please note that 2023 was impacted by a price negotiation in Germany, which amounted to a CHF 3.5 million, with an impact of CHF 2.4 million in the fourth quarter of 2023. So hence, the one only 1.3 million, but including this one-off of CHF 2.4 million. Next slide, please. Now coming to the financial guidance for 2024. Here you see, again, we split between the Idorsia business and the partner business. A part of what has already been achieved with Biotris, which is CHF 125 million that you see just in the line other before the US GAAP EBITDA line.
We do not plan for other contract revenue beyond what has already been achieved, and what is already planned with notably in the contract revenue with the supply of daridorexant to our partner in Japan, so Nxera and Mochida. Coming to the Idorsia business, so you see a non-GAAP operating loss of CHF 420 million with CHF 55 million net sales, SG&A of CHF 300 million, and R&D OPEX around CHF 165 million. With D&A and stock-based compensation, this would lead us to a US GAAP EBIT of minus CHF 470 million. Next slide please.
Sorry for being a little long, but I pass the baton to our CEO, Jean-Paul Clozel.
So thank you, André, and clearly, as I mentioned before, we want to continue to innovate, and just I would like to give you an update of the pipeline, separating what we are in control and what has been partner for the products. So on this slide, you see that first, of course, we have QUVIVIQ, which has been approved in the U.S., in Europe, and of course there is in addition TRYVIO, which has been approved in the U.S. and which should be approved soon in Europe under the name of JERAYGO. So these are the two products which we where we are not spending in phase III money now.
For lucerastat, we have not been very explicit, but clearly we have very interesting results. We have discussed with the FDA. We know what we should do to get the drug approved. And before starting a phase III, we want to really be sure on the long-term efficacy of the drug. And since we have many patients who have been under the drug for more than two years, we are doing planning a small study to check that the drug is indeed really having an impact on the kidneys of these patients. So the results will be available at the end of this year, but then we will decide what we do next.
And for daridorexant, we are the only company, which, has initiated a program in children, in, for pediatrics. Insomnia in children is a very big problem. We are doing a phase II. This is moving on, and, we hope to complete, the, enrollment in the study at the end of this year. So we have other product in the pipeline, CXCR7, for remyelination, and we are preparing, a proof of concept study. As sinbaglestat, we are, I have to say, we are just evaluating, what could be, the potential, use, especially taking into account, ruseostatin also efforts.
We have a CXCR3 antagonist, which has finished and which is ready for phase II, and a compound for undisclosed, with undisclosed, but very innovative mechanism of action in immunology. And finally, we are a few weeks before starting the entry to man of our new vaccine for Clostridium difficile. So that's the portfolio we are in control. And next to that, the portfolio which has been partnered is moving on very well. Next slide. Sorry. First is our daridorexant, which has finished with Nxera the phase III in Japan, and we are waiting the feedback of PMDA soon. Daridorexant has also completed the phase III with Simcere. Simcere has completed the phase III in China.
And, clearly, as mentioned, selatogrel is in phase III with Viatris. Things are moving well, as well as cenerimod in lupus, where the recruitment is accelerating. In addition to this, collaboration with companies, we have also a collaboration with the US Department of Defense for daridorexant in PTSD. We have also two collaborations, one with Neurocrine for our calcium T-channel blocker in a very rare and severe form of epilepsy in children, and one with Owkin, which is going to start phase I studies with an EP4 antagonist in oncology indications.
So as you see, a lot of potential upside and a very, I would say, very focused and very, I would say, pragmatic pipeline. So next slide. I think I hope that you have seen that with the QUVIVIQ sales taking off in Europe with the reorganization in the US, with the preparation of the TRYVIO launch, with this very interesting and innovative pipeline, we are ready for a new phase for Idorsia. And under the leadership of André, I really think that we are going to see a bright future. Thank you.
Thank you, Jean-Paul. That will be all from our prepared remarks and have now time to address your questions. As mentioned at the beginning, we are gonna be joined by our President of the Idorsia UK region, Benjamin Li, and General Manager and President of Idorsia US, Tosh Butt. With that, operator, please open the line for questions.
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 your name to be announced. To withdraw a question, please press star one one again. Please stand by, we'll compile the Q&A roster. This will take a few moments. Once again, if you wish to ask a question, please press star one one on your telephone keypad. Now we will take our first question, and it comes from line of Sushila Hernandez from Van Lanschot Kempen. Your line is open, please ask your question.
Yes, thank you for taking my questions. I have two on QUVIVIQ. So for QUVIVIQ, you've changed your commercial approach, so we see in March 2024 that payer pay is now at 73%, while there is a drop in U.S. net sales versus December 2023. Is there a delay, or why does it not translate in sales? And then secondly, could you elaborate on the next steps for QUVIVIQ descheduling and what kind of timelines we're looking at? Thank you.
Thank you, Sushila. Tosh, I guess those questions are for you on the details of how the past two quarters have performed and on the process of the citizen petition.
Sure, I can go ahead, Andrew. So yeah, even though our percentage of payer paid prescriptions reached 73% in the month of March, which we're really happy with in terms of this continuing evolution since launch, the reason why there's been a dip in the net sales when the volume only went down slightly, is because in Q1, you typically have the beginning of the year patient plan reset, where patients have to work through their deductible before they're able to benefit from a lower out-of-pocket co-pay.
Put another way, the co-pay, the co-pay buy downs that patients were utilizing in January and February in particular, are higher than what we would expect to see in the rest of the year, given we've now reached a point after Q1, where the vast majority of patients have burned through their deductible and then can benefit from the traditional co-pays that they pay. Hopefully, that clarifies why there's been a dip in revenue in Q1 versus vis-à-vis volume that could be potentially confounding with our overall increase in payer paid prescriptions. The second question relating to the citizen petition. Look, I mean, all we can say here is, to build on André's comments, we continue to make progress on the process.
This is a process where the timelines are unclear and the process isn't always very clear, but we are encouraged with the progress that's taking place. And as a reminder, we hope that the DEA and the FDA will continue to work together to analyze the data that we've submitted in our citizen petition, and we hope that they will accelerate the analysis that they're conducting, which is the eight-factor analysis, their independent analysis of the data, and then make a decision on whether the actual rulemaking process can start. So timing of proposed and final rulemaking in an informal or formal process varies on the subject matter.
Look, I, I don't want to speculate at this stage as to how long it could take from today, but we continue to make progress, and we're pushing hard to make sure they have all the available data to make that decision.
... Thank you, John, for that color. That's great. Thank you.
Thank you.
Thank you, Sushila.
Thank you.
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. The speaker for the questions on the phones.
Okay. Well, there seems to be another event being competing ours. So,
My apologies. We have another question come through from Sushila Hernandez. Are you happy to take it?
Yes, please.
Of course. Not a problem. Just give me a moment. Sushila Hernandez, your line is open. Please ask your question. Excuse me, Sushila-
We can't hear you.
Your line is open.
Oh, apologies. I was on mute. Could you share where you stand on partnership discussions regarding aprocitentan and your base case scenario? Is it that you'll bring it to the market on your own? The second question, could you also share some color from your payer discussions that support the WAC price of $775 for TRYVIO? Thank you.
Thanks, Sushila So I'll hand over the aprocitentan question and partnership to André. And then, Tosh, can you then follow up on the WAC price setting of TRYVIO in the U.S.?
Sure. No problem.
Andre?
Regarding aprocitentan, as you've seen, we are preparing for the launch to make the drug available to U.S. patients in the second quarter of this year. Potentially a commercial launch by our own early 2025. That's for U.S. By the way, in the CHF 300 million SG&A in our guidance, CHF 35 million are earmarked for aprocitentan. We see how things will develop, how much we would have to do. This will of course depend on some ongoing discussions for potential collaboration regarding aprocitentan.
We'll not be able to make more comments with respect to this process. It's of course much easier to go forward for potential collaboration. I use collaboration because I don't want to mention out-licensing a deal. There are various possibilities for such a collaboration, including potentially a joint venture. But it's much easier to do it with aprocitentan now being approved in the U.S. and on the cusp of being approved in Europe, in both territories with a very strong label.
Thank you, André. Tosh, you want to elaborate on TRYVIO and pricing setting?
Thank you, André. So, first of all, thank you for the question. So yes, you're right. At the end of April, we announced our monthly WAC or list price of $775, and we view this as an appropriate and very much justifiable price based on the value of the innovation that TRYVIO brings. It's addressing significant unmet patient need. As many as 50%-60% of these treated hypertensive patients remain uncontrolled, and the more medicines they're on, they have a greater exposure to negative and very expensive and very dramatic cardiovascular events. It's the first novel innovation, novel pathway, and the first new mode of action for systemic hypertension in almost 40 years.
And then I guess the most important thing we looked at is, we looked at the clinical profile of aprocitentan, TRYVIO, which I do want to reflect on here. We talked about the significant unmet need, the limitations of existing treatments available to physicians and patients today, particularly the extremely limited number of medicines with significant, I would say, drawbacks. Once you get past the base three medicines of an ACE or an ARB, a diuretic, and a calcium channel blocker, physicians don't have much choice, patients don't have much choice. And many of that fourth drug, many of them have inconvenient dosing, they have drug-drug interactions, they have adverse events, and some case, a limited efficacy that limits their use.
And so in our conversations with payers, what I can tell you is they've been intrigued by our novel and unique mode of action, because this endothelin pathway remains unopposed with today's treatment. And we believe in the impressive blood pressure efficacy that we see with TRYVIO across all patient subgroups. The fact that it can be used in renally impaired patients with eGFR as low as 15, which is a pretty unique selling point, with no documented risk of hyperkalemia, another unique selling point. Remember the over 90% of these resistant, uncontrolled hypertensive patients, they have comorbidities, typically diabetes, obesity, dyslipidemia, and CKD, and other cardiovascular overlapping comorbidities. And what that means is they're often taking three, four, five, six, seven, eight other medicines.
And so the fact that TRYVIO, you can add it and have no concern about drug-drug interactions is a significant advantage. There's no need to adjust the dose of TRYVIO. There's no need to adjust the dose of any concomitant medicines these patients are inevitably taking. So safety for patients, convenience for patients, and the same for physicians, and you get all of this from a once daily tablet. So we've coupled this, our thinking, with extensive interviews with payers, extensive market research, and including one-on-ones with former senior execs at these large organizations.
We've taken into account the monthly WAC prices of the currently available drugs for these patients, and so we feel $775 is a very fair and very justifiable price that will allow us to get the necessary access that we need to get this drug to patients at the right time. Thank you, Andrew.
Great, Tosh. I can hear very, very, very clearly. Excited about bringing Tosh to the market. Operator?
Tosh.
Tosh.
Trivio.
Tosh to the market.
TRYVIO to the market. Operator, are there any questions left?
There are no further questions, and I would like now to hand the conference over to the management team for any closing remarks.
Thank you very much. I think for today, that closes our call. Thank you for your ongoing interest in Idorsia. We look forward to speaking to you again. Lastly, our next scheduled event will be for the first half year 2024 results on the 25th of July. Be prepared for more. Operator, please close down the lines.
That does conclude our conference for today. Thank you for participating. You might now all disconnect. Have a nice day.