Good morning. Good afternoon, everyone, and welcome to the Idorsia First Half 2022 Webcast. With me on this call are our CEO, Jean-Paul Clozel, our CFO, André Muller, and our Chief Commercial Officer, Simon Jose. They're all here to provide additional color to the press release and first half 2022 financial report published today at 7 A.M. Central European summertime. Next slide, please. We will first be making prepared remarks, and then we'll address all of your questions at the latter half of this call. Before kicking it off, I need to remind everybody about our disclaimer. We will be making forward-looking statements in this call. Hence, you have been adequately warned about the risks associated in investing in Idorsia shares. Next slide. With this said, Jean-Paul, the floor is yours.
We on slide three. When we created Idorsia five years ago, we had a clear goal to become a full-fledged biopharmaceutical company. Just five years after the creation of Idorsia, I am very pleased to report that we are really on a very good track to achieve this goal. Next slide. We are set up from day one, and we have not changed this priority list. We had defined five key priorities. First, deliver three products to the market within a midterm time. Number two was to build a world-class commercial organization to be able to retain the value for our discoveries. Number three, to bring as fast as possible Idorsia to sustainable profitability. To continue to fuel our pipeline with new discoveries. Finally, to utilize state-of-the-art technologies to drive innovation within the company.
Slide number five. Let's look at what we have achieved within these five years. First, two products are on the market, QUVIVIQ in the U.S., PIVLAZ in Japan. We have got very good results of aprocitentan, which I will describe briefly afterwards. We are on a good track to get soon three products on the market. The U.S., Japan, and European organization are now established, and we are starting to have revenues. I do believe that we are on the path, as we have mentioned, to reach profitability in 2025. We have also continued to discover drugs, and on top of the existing drugs that we had five years ago, we have now a very rich pipeline with some new products moving to phase II or to phase III.
Finally, we don't have time today to go into the details, but I can tell that we're using state-of-the-art technologies in research, but also in marketing, where all the most modern tools, including artificial intelligence, are used in order to optimize our revenues for marketing, but also our ability to discover new drugs. Slide number six. we want, and that's a very clear goal, we don't want to be one of these biotech companies which are not profitable after 20 years. We want to become profitable as soon as possible. in order to achieve that, we want to combine not only revenues from our commercial products, and we intend to commercialize QUVIVIQ, PIVLAZ, but also lucerastat, cenerimod, and selatogrel. we want also to have revenues from milestones and royalty streams.
As you know, we get 8% of the sales of ponesimod, which is PONVORY, marketed by Johnson & Johnson. We will have a significant part of the revenues of aprocitentan. We are waiting the results of the T-type calcium channel blocker, which has been licensed or partnered with Neurocrine. We are also expecting that vamorolone is going to be approved in not a too distant future and bring also milestones and revenues to Idorsia. Now let's start with the first part of this revenue, slide number seven. I would like to give the word to Simon Jose, who has been very efficient to build the commercial organization all around the world. He was the first person to have this task and to have to do.
I have to say that he has done a fantastic work and is going first. To discuss the results of his efforts and the efforts of the U.S. team with the launch of QUVIVIQ. Of course, he will also describe the launch of PIVLAZ in Japan.
Thank you, Jean-Paul. As Jean-Paul has said, it's a very exciting time for Idorsia as we launch our first two products. I'm very pleased to be able to share with you today the positive early momentum we're seeing with both Q UVIVIQ in the U.S. and with PIVLAZ in Japan. Next slide, please. Starting with QUVIVIQ, which, as you know, was launched in May. The feedback we have received from healthcare professionals and patients has been very positive, and we're very encouraged by the steady growth in prescriptions and physician adoption, which I'll share with you in a few minutes. Of course, before any of this can happen, we need to build awareness among prescribers. As you can see here on the right, we are making good progress here.
With physician awareness of QUVIVIQ already at 52% in June, just the second month into the launch. Next slide, please. Awareness is building, but what about physician receptivity to the profile of QUVIVIQ? This slide shows the results of some market research we conducted prior to launch, with a blinded product profile. It shows physicians were highly attracted to using QUVIVIQ compared to the other medications they use to treat insomnia. As you can see, 60% of physicians were passionate about using QUVIVIQ, that's the green segment, or attracted to using QUVIVIQ, the blue segment. Of course, this was significantly greater than all other products in the category, and importantly, nearly twice the level of the other two DORAs in the panel. Next slide, please.
The feedback we have gained from market research about the product profile is translating into positive feedback from doctors about their experience with the product. These quotes are just a few examples of the dozens that we have received with similar themes, and I'll just give you a moment to read them. In fact, I was in the U.S. last week and spent a day with one of our sales representatives in Washington, D.C., where I received similar comments and feedback. Interestingly, I had one doctor tell me she had switched 13 patients from Ambien to QUVIVIQ and hadn't heard a thing back from any of them. When she saw the slightly puzzled expression on my face, she quickly went on to say this was very good news.
She was perfectly clear that these patients would have got straight on the phone if it wasn't working out. In many cases, no news is good news in this category. Next slide, please. Turning now to the numbers. As you've seen in the press release, net sales in the second quarter were CHF 0.4 million. This clearly is not reflective of actual prescriptions dispensed or of product demand. As to enable patient access and generate early demand, we are providing a robust patient support and co-pay program, including a first 30-day prescription free. As you're aware, patient support programs are becoming commonplace now to support new launches during the period where insurance coverage is being built. Furthermore, you should also note that we did not actively stock the channel at launch. Next slide, please.
Now, as many of you know, we are partnering with a specialty pharmacy services company, VitaCare, to manage a key component of our patient support program. Now, while this makes it easier for patients to get their prescriptions filled, it makes the reporting of QUVIVIQ prescriptions more difficult. IQVIA does not currently include VitaCare in its sample bank, and therefore its syndicated report underreports prescriptions for QUVIVIQ. We have full transparency of the VitaCare data and combined VitaCare and IQVIA without over or under counting. As we communicated in early May, we will report these data during our quarterly earnings calls. Here you're seeing the first set of them from launch through July 15th, with the VitaCare data being added to the IQVIA numbers in the chart.
You're essentially seeing the IQVIA line at the bottom, then the VPS number, VitaCare, and then the total prescriptions in black. I think as you can see, we have good momentum in the growth of prescriptions dispensed with the most recent data point exceeding 1,100 prescriptions for the week ending July 15th. You'll also notice a few dips during the weeks where there was a national holiday in the U.S. This is a normal pattern created by vacations, reduced doctor visits, and reduced pharmacy hours during the weeks in question. Next slide, please. Now, taking a closer look at some of the early data, we are particularly pleased with the adoption of the higher 50 mg dose.
You will see on the left that around 75% of prescriptions are for the 50 mg dose, which is expected to offer the best efficacy for the majority of patients. We believe this, along with the 30-day first prescription free and a clear nightly dosing message, will help enable a successful trial, something we know is critical in insomnia. Additionally, we are seeing around 60% of prescriptions being written with at least one refill, with over 20% having four or five refills attached, and repeat scripts are starting to be filled. The chart on the right shows the number of writers per week, the number of physicians or nurse practitioners. You can see the strong growth in total writers as we add new writers every week. We now have nearly 2,700 writers after 10 weeks on the market.
You'll note the data on writers is only through July 8th. There is a week lag in obtaining these data versus the total prescription data where we have through July 15th. Next slide, please. This is perhaps the most important slide I'll show you today. It's showing the NBRx's of the three DORA products from our launch in May through July 15th. As you can see, QUVIVIQ went past Dayvigo after only six weeks on the market. Now think about that for a minute. Dayvigo has been on the market for two years, and after only six weeks, more new patients have been put onto QUVIVIQ than are being put on to Dayvigo. With the current trajectory, it won't be long before we are through Belsomra too.
Now, this matters a lot, not because the existing DORAs are a material source of business for QUVIVIQ, they are too small, but because it is the ultimate proof that doctors are responding to the differentiated profile of the drug and that our messaging is resonating. In fact, less than 5% of our source of business is coming from the DORAs. The majority of QUVIVIQ is coming from new patients at around 40% or switches from benzos, Z -drugs, or trazodone around 47%. This is a very encouraging profile. Next slide, please. We're off to a good start, but what comes next? We have long maintained that consumer awareness and activation will be critical to the long-term success of QUVIVIQ, and our strategy is centered around this, as you've already seen with our pre-launch partnership with Jennifer Aniston.
We believe branded DTC and consumer activation will be an important momentum-building catalyst going forward. We have recently announced our partnership with two celebrities as QUVIVIQ patient ambassadors, actor Taye Diggs and former Olympian and champion skier, Lindsey Vonn. Both Taye and Lindsey are taking QUVIVIQ and have positive experiences on the product. They've already participated in a number of media interviews. Last week, Lindsey was on the Today show sharing her insomnia story, which then got picked up by other outlets, including People magazine. After this interview, web traffic to QUVIVIQ.com tripled from the previous days. Together, Taye and Lindsey have already reached tens of millions of consumers with their messages, many QUVIVIQ branded. In the late summer and early fall, DTC television commercials featuring Taye and Lindsey are planned to start airing.
We expect this to have a substantial impact on consumer awareness and motivating potential patients to talk to their doctor about QUVIVIQ. Overall, we are pleased with the start we have made in the first couple of months in the U.S. and are confident that as we exit the summer months and activate our branded DTC, we will see a further positive shift in momentum. Next slide, please. Looking beyond the U.S., QUVIVIQ is on track to become a global brand. Following the E.U. approval in April, launch preparations are underway in the top five European markets, with the first launch in Germany expected before the end of the year. The local teams are actively engaging with medical experts, policymakers, and payers to introduce Idorsia and raise awareness about the significant burden of chronic insomnia.
As the first dual orexin receptor antagonist approved in Europe, there is a high level of interest among medical experts in the differentiated clinical profile of the product. We have also filed QUVIVIQ in Switzerland and Canada, where we have recently appointed general managers and are establishing local affiliates. Finally, we have now completed recruitment of the phase III study in Japan and expect the top line results later this year. Next slide, please. To finish off and just turn briefly to PIVLAZ in Japan, we launched PIVLAZ or clazosentan in Japan in April for the prevention of vasospasm following an aneurysmal subarachnoid hemorrhage, a life-threatening condition which has an incidence in Japan that is 2x-3x higher than in the rest of the world. Next slide, please.
There has been no new innovation in this field for over 20 years, so the availability of a new product with high-quality evidence is creating a good deal of excitement within the neurosurgeon community in Japan. Neurosurgeons have responded very favorably to the robust Japanese phase III data demonstrating the safety and efficacy of PIVLAZ, which was published in the Journal of Neurosurgery in April this year. Next slide, please. I'm very pleased with the positive early results of PIVLAZ since the launch in April. Net sales in the second quarter reached CHF 11.4 million, and of this, nearly 70% has already been purchased by hospitals from wholesalers, and we have been receiving reorders since the beginning of May.
Approximately 60% of our target hospitals have placed at least one order for clazosentan, and as we estimate that based on the incidence of aSAH in Japan, approximately 10% of patients were treated with PIVLAZ in June 2022. We expect this positive trajectory to continue as PIVLAZ is included in more hospital formularies and treatment protocols, and neurosurgeons gain more experience with the product. In summary, our commercial organization is fully focused on executing against our ambitious launch plans for both QUVIVIQ and PIVLAZ.
We're hearing positive feedback from our customers about both of these innovative products, and we are seeing the number of prescribers and prescriptions dispensed increase steadily week over week. I'm confident that the positive momentum will continue to build after the summer months as we ramp up our consumer activation in the U.S. and continue to gain patient share for PIVLAZ in Japan. With that, I'll now hand over to André.
Thank you. Thank you, Simon. Let's move to slide 21. I don't see on the slide how the U.S. GAAP numbers build over the first half. Let's first start with the net revenues. Simon alluded to the CHF 11.4 million sales of PIVLAZ and the CHF 0.4 million of QUVIVIQ. As you know, we report net sales and not the gross sales, so it does not really reflect the demand and sales volumes, notably for QUVIVIQ. We had also roughly CHF 11 million contract revenues, little more than CHF 10 million were deferred from a previous out-licensing deal, so a milestone, and slightly less than CHF 1 million relating to Ongory.
We come back to the CHF 407 million non-GAAP operating expenses in a minute. This led us to a non-GAAP operating result of CHF -384 million with the usual D&A and stock-based compensation. The U.S. GAAP operating results reported were CHF -405 million. Below EBIT, the CHF 15 million is mainly relating to financial expense, CHF 8 million in connection with your convertible bond interest and CHF 4 million on the unrealized loss, notably on the Santhera shares in connection with the tax expense. This led to a U.S. GAAP net loss of CHF -490 million. Next slide, 22, please.
Coming back to this non-GAAP operating expenses, you see, we had a small increase in R&D totaling CHF 180 million, of which you had a fixed cost base, mainly in research, more than CHF 72 million, actually, study expenses, of which CHF 60 million were really on five compounds. Selatogrel with the ongoing phase III SOS-AMI, where we see a nice increase in the recruitment base and the development of the Cardiorenal. We have daridorexant with the Japanese trial that will be finished before year-end, and also the initiation of the pediatric one.
We had cenerimod with the completion of the phase III. Lucerastat also mainly with drug substance and clazosentan finishing the western trial, REACT, that should also read out by the end of this year. Of course, your big jump is in the SG&A with CHF 226 million, slightly higher in G&A, reflecting also a more global footprint in the U.S., in Japan, and now starting also with the launch preparation, having now six affiliates in Europe and Canada, plus, of course, the marketing and selling mainly are driven in the U.S. with QUVIVIQ and to a lesser extent with the launch of PIVLAZ.
CHF 407 million, a huge increase compared to last year, CHF 248. Next slide, please. 23. You see here the cash flow. Liquidity cash flow reconciled with liquidity was -CHF 455. Shortly at CHF 407 non-GAAP OpEx, we just discussed. CapEx of CHF 18 million, you have usual stuff in CapEx with CHF 12 million, and you had also a CHF 6 million milestone in connection with the Japanese approval early 2022. Working capital changes, CHF 42 million, mainly buildup of inventories to supply both U.S. and Japan with QUVIVIQ and PIVLAZ.
CHF 22 million increase in receivables, as one can expect with the sales which are out. CHF 10 million and the rest is other receivables or payables. Last year you had CHF 12 million with others. That's mainly relating. You have a lot of movement here, but your main one is your deferred revenue of CHF 11 million. We ended the second quarter with a liquidity of CHF 733 million. Next slide, 24, shows this liquidity between cash and cash equivalents of 230 million and deposits of less than 12 months, CHF 500 million. You also see how this liquidity is held mainly in Swiss francs, CHF 572 million, and also in US dollars, $146 million.
Next guidance 2020. Relating to operating loss, CHF 840 million U.S. GAAP excluding D&A and SBC, and mainly non-GAAP operating loss should be as we indicated with your full year results. As mentioned in your press release, Q1 CHF 785 million for non-GAAP. We need more visibility to guide on net sales, a little more than two months after the launch in Japan and less than two months because your drug was not available in the retail channel before mid-May for PIVLAZ. We are committed to spend around CHF 785 million net between R&D and SG&A and time and profitability target.
No change here, but I'm more confident than when we initially published this guidance, which was based on our directly funded U.S. products that are approved. I know the strong results of aprocitentan in resistant hypertension. We have no doubt the drug will be approved in the U.S. and in Europe. We will get higher annual net sales of over CHF 500 million. Jean-Paul. Jean-Paul, the floor is yours.
Thank you. Sorry, you were cut, André. Sorry, André, but we can answer the question to clarify a few points that you made. As you said, you know, our expectation of becoming profitable in 2025 did not include aprocitentan income. I think that the good results of aprocitentan show us the importance of building and continuing to build a pipeline. How is our pipeline moving? Slide number 28. On top of daridorexant, which is now basically we are waiting for the Japanese results in end of this year. For clazosentan, all patients within REACT have been included, and we are now analyzing, and we need to have a six months follow-up.
The results should be available end of this year or beginning of next year. Mostly, mainly beginning of next year. Aprocitentan, we got the results. I will describe them later on. All the other projects are moving except the selective DORA in BPH, which was not positive. We are absolutely, we have decided to stop this program and we eventually evaluate what should we do with this compound. We have other drugs which are finished. We have finished phase I such as the CXCR7 antagonist for multiple sclerosis, a very interesting product. The other product, which are nearly ready to initiate phase II.
Of course, for all these programs, we are evaluating how to optimize the value for this product. Is it by doing keeping the development for us or partnering? Of course, in very competitive areas, we are choosing a partnering solution. Next, slide 29. I mentioned the result of aprocitentan. This was for me a very important result because we have been working on these drugs within Actelion and then Idorsia. It's a result basically of 30 years of research of endothelin. It's really an optimized mixed dual endothelin receptor antagonist. What we saw is, I think, very clear.
Aprocitentan reduced blood pressure compared to placebo and all the methods which have been used to measure blood pressure, being at the doctor office or ambulatory at home or after withdrawal and with using these two methods. All results are consistent and show a very significant effect of aprocitentan on blood pressure. As mentioned, the effect, and this is maybe the first time that in so severe patient such a long evaluation has been done, but the effect is maintained and very well confirmed after a period of 48 weeks. Very interestingly, the effect has been observed in a group of patients which are known to be resistant to usual antihypertensive drugs.
Very important to remember that this was done, this study was done on top of a triple therapy for 40% of the patients, but quadruple therapy, meaning, a calcium antagonist and a diuretic, an angiotensin II receptor blocker, and a beta blocker in 60% of the patients. Also you will see when the results will be available, that this was in very severe patients combining heart failure, renal failure, obesity, diabetes for nearly 50% of these patients. This is why the very good tolerability and safety that we have observed is so important. I'm very confident that this drug is going to satisfy a highly unmet medical need in these patients.
What are the next steps with aprocitentan? Slide number 30. We want to file the NDA before the end of the year. We also, of course it depends on the acceptance of abstracts and so on, but we want to show the results in a scientific presentation as soon as possible, and we want, of course, to submit this result for peer review publications. Clearly, we have increased our interaction with Johnson & Johnson, with Janssen, who is in charge of the commercial launch, because we of course want to have the best label and the label which also correspond to the need for a successful marketing. Next slide.
Already, if we are half year in 2022, and when we think of what we are able to achieve in this first year, it's quite impressive. If we summarize what has happened during the first six months of 2022, we had QUVIVIQ approved in the U.S., clazosentan approved in Japan, the commercial launch of clazosentan initiated in Japan, the commercial launch of QUVIVIQ initiated in the U.S., QUVIVIQ approved in Europe, and we obtained the results of aprocitentan in phase III, final results. Now, the rest of the year is going to be also very important because QUVIVIQ is going to be launched in Europe.
I do believe that Europe is a fantastic ground for commercial success of QUVIVIQ because no innovation in the sleep domain has been happening for drugs within the last 20 or 30 years. In the second half of 2022, we intend to launch the phase III with cenerimod. We have discussed with the FDA and we are integrating all the requests and all our also learnings from the phase II within our phase III, which should start before the end of this year. As mentioned, we'll get the results of daridorexant phase III in Japan, which will be the base of an NDA in Japan.
We want to finish the phase III of clazosentan for Europe and the US. This phase III is called REACT. As you see, a lot of things will happen, and I'm not discussing all the brand-new products that we are discovering, and I can tell you we have made some breakthrough in several areas, so be prepared for more. Thank you.
Thank you, Jean-Paul. This concludes our prepared remarks, and we are now happy to move on to the Q&A session of this call. On logistics, may I quickly ask you that when you formulate your questions, that you limit them to one question only and drop back into the queue. Furthermore, you have the opportunity to write your questions on the webcast, and we'll be able to then take them up in this forum. Operator, please prepare the lines.
Thank you. As a reminder, to ask a question over the telephone, you need to press star one one on your keypad and wait for your name to be announced. Please stand by while we compile the Q&A roster. We'll now take our first question. This is from the line of Peter Verdult at Citi. Please go ahead. Your line is open.
Okay. Well, look, I have three, but I will play by the rules and ask one and drop back in the queue.
Thank you.
When we speak to patients and docs, the message points that you've given do resonate. Payer access was always gonna be the issue. You previously talked about balancing the need to drive access with not giving away too much on rebates so early in the life cycle of the product. Do you think you've got that balance right at the moment? And can I push you on whether when we could expect one of the big three PBMs to provide access? Could something happen before year-end? Thanks.
Yes, I think we're where we want to be. We're in discussions with every single large plan. We're in that cat-and-mouse game, Peter, as we've talked about, where we're, you know, trying to trade off driving demand to make sure that we can have the right conversation about when and how much versus the long-term potential of the product, which has a patent life of 15 years. After two months, I wouldn't expect to have been presenting a contract. To be honest, if I had one here now with you, I can promise you I would've paid too much. I can't tell you when it will be, 'cause that's a lot gonna depend on, A, it's confidential. B, it obviously depends on how we go with the demand and where we net out.
I'm completely comfortable where we're at the moment. It really is about driving demand so that the payers can respond.
Peter, it's Jean-Paul. Just wanted to insist. This is, and I am very convinced when I see the data, when I see the feedback on the market, this is going to be a big success. We are already going to be, I really think before the end of the year above Belsomra. We are going to be the new product in sleep area, the real breakthrough that people are waiting for a long time. It would be crazy for us to give up by accepting too high rebates, to give up too early. This is a long-term decision. Of course, it's always very tempting to give up, but we are not going to give that.
We want a decent discount and this is going to happen, and this is why we need to be a little bit patient, because the time is working for us. You know, you see the steady increase of the demand, and at one point, I'm pretty sure we will find a very good negotiation solution with this PBM.
Thank you.
Thank you, Jean-Paul. Thank you, Pete. Operator, next question, please.
Thank you. We'll now take our next question. Please stand by. Question is from the line of James Gordon from JP Morgan. Please go ahead.
Hello, James Gordon, JP Morgan. Thanks for taking the question. I'll go for QUVIVIQ, please. You previously did issue 2022 revenue guidance, and then you now have withdrawn it. Is that 'cause of challenges with coverage and more couponing or couponing going on longer, or the two are interlinked? Is that the reason? If so, how much better could the couponing situation be in Q3? Should we assume a lot less couponing or might it be a similar amount of couponing? If we try and extrapolate your chart, I think it says on slide 13 that 60% of coupon patients have gone on to become refill patients. Does that mean that is how we should think of it? That's like your conversion into paying patients for Q3?
If I could squeeze in, just a clarification point. I think I saw a comment in the release about non-equity dilutive instruments. Does that basically mean debt issuance in H2?
I mean, I think the first thing I would say is that we probably have hit a tougher environment that we're launching into with COVID. I was in the U.S. last week and as I said, you go into the doctor's offices, and they're still, some of them aren't seeing patients face-to-face. They're still dealing with backlog and catch up. In that context, pulling patients in on insomnia isn't top of their list. I think we have a challenging environment that we're launching into. We had a couple of operational things that we've since squared away around electronic health systems.
It's taken us a while to get them all up and running because some doctor's offices are on three-month contracts, and therefore, when you have to write prescriptions electronically, a number of those doctors couldn't do that in the first month or two. So we've had a few sort of headwinds that we've been battling with, which I think is what perhaps has slowed the demand slightly. But as I say, I think if you look at the charts now, we are breaking through that, and I think we're very pleased with what we've got. It's perhaps a little bit delayed compared to where we thought we would be. I don't think at this point, contracting is part of it. I don't think we would expect to have big contracts and open access at this early stage of the launch.
I think it's about driving demand to make sure that we can subsequently open those contracts up. Regarding your second point on the 60%, just to be clear, in the slide I showed, it's 60% of prescriptions written include a refill or more than one refill. It's not that. We are seeing those refills being filled. Just to give you a sense of what's happening at the moment, we've looked at the first few cohorts in May, and the majority of prescriptions where they had a refill, that refill's been filled, and the majority of the time it's in 32 days or less.
Okay.
Equity question.
Yeah. Thank you, Simon. André, are you still on the line?
Of course.
Okay. Do you want to take the?
Sorry, I missed the question of Peter.
No, it was James Gordon asked the question about.
James.
What potentially could be a non-equity financing?
Well, I'm afraid, James, you will need that we are a little more patient, couple of months before we can announce such deals. You know, I indicated sale and leaseback, I indicated the royalty-related deals. We are working on it. As you can imagine, getting these strong results for aprocitentan will dramatically help. It will be around these two type of instruments, in order to again start 2023 with a strong balance sheet and more than 12 months cash runway.
Okay. I think James was explicitly asking whether debt could be part of that financing tool.
Could be one of the avenue.
Thank you, André. Operator, next question, please.
Thank you. We'll now take our next question. This is from the line of Dominic Lunn from Credit Suisse. Please go ahead.
Thank you. It's Jo Walton here from Credit Suisse. I'm afraid I'm sorry to be like a stuck record and still on QUVIVIQ and access and payments. We see that you have a $0 Copay to start with, and then you have a renewal of $25 a month. If I was a payer and I could see that my patients could get free product initially, and then they could get refills paid for by Idorsia at $25 a month, which is probably roughly what I'd be charging them for tier two, what is the incentive that brings the payer to come to Idorsia and say, "I want to get involved?" I guess my question is, how long is this couponing going to be going on?
Specifically, if I were to look for a coupon today, how long could I look to be getting effectively free product before I have to suffer any material financial pain? Thank you.
Hey, Jo, it's Simon. I think it actually works the other way around, I think, in that we right now estimate we've got 20% access, and we're obviously looking to drive business through that 20%. We are also every single patient that goes through VitaCare, additionally is going through the process which can ultimately lead to a prior authorization application. Some of a good number of which, by the way, are being approved. Everything in that 20%, plus prior auths, the payers are paying for full price with no rebate. They also do respond to patient need, patient volume.
As we start to generate demand and we go through Dayvigo, we go through Belsomra, and they see true demand in the marketplace and they start paying full price with no rebate for the business that's going through, then there is an opportunity for us to have that conversation. That's traditionally the way that the market works. Right now, I don't blame them. Right now, they say, "Hey, guess what? I've got Belsomra, I've got Dayvigo. Why the hell should I give you a contract for QUVIVIQ? It could well go the same way as the other two." It isn't. We're already demonstrating that the volume is in on a very different trajectory than the other two.
Once that picks up and once they start seeing what they're paying for the covered lives, then I think we'll be in a very different place to have that conversation. With regards to the timing of couponing, that will depend on where we get to with the payer contract. Essentially, once we start to see commercial coverage come up, then that will obviously come down.
Can I sneakily just check then, 20% access rate is a good enough rate to trade off against the cost of a national direct to consumer campaign in September, when you haven't got that much access to pay it back?
Yeah, I mean, over several years, yes. Because it's, you know, it's a primary care drug. We don't expect to break even in year one. Usually, you're looking at a profitability for a primary care drug in year three. We're targeting. As you know, as a company, we put out guidance to be profitable in 2025.
Thank you.
I think that.
Thank you, Joe. Operator, next question, please.
Thank you. We'll now take our next question. Please stand by. This is from the line of Manos Mastorakis from Deutsche Bank. Please go ahead.
Yes, hello, everyone. Just wanted to get a better sense of PIVLAZ's revenues phasing for the next few quarters, if you can make a comment on that, please. Thank you.
I'm not gonna comment on future revenue projections. The thing I think I know is on a lot of people's minds is how much of this is real and how much of it is stocking in terms of what we've reported out already, which I obviously can tell you retrospectively. I'll give you an example. In June, for example, wholesalers reordered 90% of what they sold out. I think we're already at a point where we're at steady state in terms of what's in. In May, it was 70%, and in June, it was 90%. The volume that they sold to hospitals, they essentially reordered 90% of that volume from Idorsia.
I think that it's Jean-Paul. I think this PIVLAZ has always been underestimated as a potential because people underestimate first how big the problem of these patients is, especially in Japan. The Japanese have done you know are basing their prescription on results obtained in Japan. You know it's two full studies. The whole NDA is not only based on in terms of safety on all what we have done in Europe in the U.S. but mainly on two pivotal studies in Japan. Most of the best centers have been involved and this explains why the pickup is fantastic at the beginning of this launch. I am stunned to see that already as mentioned we are treating 10% of the patients after two months.
Imagine what is going to be at the end of this year. You can expect, and I'm good, I would say good surprise for PIVLAZ, compared to the expectation of the market, this year.
Thank you, Jean-Paul. Operator, next question, please.
Thank you. We'll now take our next question. Please stand by. The question is from the line of Raghuram Selvaraju from H.C. Wainwright. Please go ahead.
Thanks very much for taking my question. This is just with respect to the long-term view on QUVIVIQ. Can you comment on potential additional sleep disorders that you want to explore with the drug, given its profile and treatment of insomnia, particularly with respect to conditions like jet lag and shift work disorder?
You know, we have, especially in the U.S., I have to say, we have a label which doesn't exclude jet lag, any sleep disorder. We have chosen as a strategy to go with the big indication that has the largest label. We discussed it with the FDA, so we have no restriction. Frankly, our marketing goal is certainly not the jet lag one or two drug. The real, what we have observed is that the benefit increase with time. I think the chronic insomnia is really our target. There are millions and millions of patients and tens of millions of patients with chronic insomnia.
What we want during the first years is to focus on marketing effort to explain that this is a chronic disease like hypertension, diabetes, where you need to be treated every night. I think that if we would start to discuss jet lag, it would be a little bit against this message. I think it is a fantastic drug for chronic insomnia. I think it's, it could be good and we didn't do the study. People, if they want to take it for jet lag, they can. Frankly, when you take this drug every day, this is where you have seen the benefit that we have described in our Lancet paper on daytime performance, and this comes with time. This is really a drug for chronic use.
Thank you, Jean-Paul. Thank you, Ram. Operator, next question, please.
Thank you. We'll now take the next question. Please stand by. It's from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.
Hello, can you hear me?
Yeah, we can.
Yeah.
Thank you for taking my question. It's just about the agreement with Syneos Health. Just wanted to know if you could give us some color on the you know how this partnership has been going. If you had to make any adjustment to the agreement, incentive structure or anything. Basically what you learned you know since the launch in relationship with the agreement compared to your initial expectation. Also still on the same topic if for some reason you want to take back control of marketing you know for any reason how binding is this agreement and how much freedom you have here in terms of doing that? Thank you.
Thanks, Thibault. Let me start with your second question or part of question first. Just to be clear, we are in full control as Idorsia of the marketing, the pricing, medical and everything to do with the strategy of the product. Syneos essentially are providing sales force services to us. We're pleased with the way that's all going. We've had to make no adjustments to the contract. I know I've said this before, but we need to be very clear that Idorsia is in full control and has built the capabilities for all of what I would describe as the strategic capabilities that the organization requires for the asset. Syneos is providing sales force services in partnership with us. They're doing a very good job.
We're pleased with the quality of the sales force that they've stood up and we've had no cause to change anything to do with the contract.
Thank you.
Thank you, Thibault.
Thank you.
Operator, next question please.
I'll now take our next question. Please stand by. This is from the line of Rosie Turner from Jefferies. Please go ahead.
Hello. Good afternoon. Thank you very much for taking my question. I will start with one also. How are you thinking about the launch plans in Europe? I suppose it will vary in terms of country access. I think before you've spoken about Italy, but I just wondered if there was an update there. Thank you.
I mean, we're expecting actually to be launching Germany first. As Jean-Paul said, we look at Europe. We're bullish about Europe because the unmet need is huge, just as big as it is in the U.S. In fact, the number of patients on prescription medicines in Europe per capita is higher than the U.S. I think that's probably because there's more OTC use of sleep meds in the States. Many of the European regulators and even some of the payers are really quite concerned about the long-term use of Zs and benzos and put restrictions around their use. Being the first DORA to come into the European market against that backdrop gives us a lot of confidence in the opportunity ahead of us.
As I say, we'll launch in Germany later in the year, and then, as you rightly say, we'll roll other markets out through the course of, you know, across the end or beginning of the year and into 2023, dependent on market access. You're right that Italy is a self-pay market, which means we won't have to wait all the way through a long, protracted reimbursement process in Italy. There is potentially an opportunity for us to think about a similar approach in Spain. Otherwise it will be linked to reimbursement, particularly in the UK and France.
Just, you know, I wanted to add that there is something very special for Europe, that the label of QUVIVIQ in Europe is quite extraordinary, I have to say. It's really for insomnia on chronic use. You know that in Europe, every drug, most of the drugs, I have to say, especially benzos, Z -drugs, are limited to a few weeks of treatment. Here, it's the first chronic insomnia drug which is approved for chronic use and which is also approved for patients who have really daytime consequences. There is, in the label, very clear mention on the fact that it should be really.
It's going to work, especially in patients with chronic daily impairment of their daytime performance, and that there is a benefit of QUVIVIQ in this patient on daytime performance with the 50 mg. We have a very, very unique label, which is unique as an insomnia drug because it's the only drug. This is very important for reimbursement because nobody can compare to a drug which is not approved for more than a few weeks. It really, I think, is very helpful, the reimbursement. It is really a drug for chronic use and for patients with a daily impairment of their activity. This is what we try to really integrate into our launches, and we are working on that in every country.
In addition to having chronic labeling, just to add the IDSIQ data on daytime performance are also in the European label, which is very beneficial for us in Europe.
Perfect. Thank you.
Thank you. Next question, please.
Thank you. We'll now take our next question. Please stand by. On the line of Keyur Parekh at Goldman Sachs. Please go ahead.
Hi. Thank you for taking my questions, please. The first one is, if I look at consensus for 2022, we've got QUVIVIQ sales of about CHF 70 million and then 2023 at about CHF 250 million-CHF 260 million.
How comfortable are you with consensus numbers? Do you think they are broadly in the right kind of ballpark, or do you think given some of the decisions you're making from a commercial perspective, we should be thinking about a different curve to the ramp? Thank you.
Hi, Keyur.
Ask André.
André, are you on the line? Do you wanna take that, or do you want me to take that?
No. Yeah. Well, I can take it. You've seen that we maintain our net operating loss guidance, but we no longer break it between sales, other revenue, and OpEx because we need a few more weeks to get more visibility on the uptake, mainly for QUVIVIQ in the US. I will not comment on the consensus for 2022 and even less comment for 2023 and after. As we said and Simon agreed to it, you know, we have almost 13 or 14 years of IP protection.
We will not sacrifice short-term profitability or sales by contracting with payers. We really want to extract the most value of QUVIVIQ, notably in the U.S. We'll give Q4 full year certainly more color with your Q3 results. Right now it's premature.
Thank you, André. Thank you, Keyur. So we got one or two questions coming in through the webcast. One of them is for you, André, on the back of the non-equity financing possibilities throughout the remainder of this year. Do you wanna give us some more granularity as to what those could be and then when they could be actually happening?
Well, we are definitely actively working on it. I'm confident that, again, we'll ink a few deals. Will it be in Q3 or early Q4? I don't know. For sure, our objective is to raise cash with either, as said, sale and lease back and/or R&D related monetization or R&D related deals or even structured debt. Between this combination plus, Jean-Paul also mentioned it, but you know, out-licensing takes time. I hope also that we ink a few out-licensing deals.
I'm really confident that we'll raise a significant amount of cash, putting us in a very strong position starting in 2023.
Thank you, André. We've got another question on do we have an update on the development of lucerastat, Jean-Paul?
I think that we are basically continuing the open label phase, and we are preparing a discussion with the authorities. We have seen, as mentioned many times, very interesting data on the, I would say, end organ protection with this drug. We want to confirm this data with as much information as we can. We are using basically all the new technologies and the new techniques to evaluate this effect. For example, you are using artificial intelligence techniques to really compare with a sort of placebo untreated group. We will discuss at the end of this year with authorities the results.
Since the protection of this drug, of lucerastat, is going to be through orphan protection, we prefer to take our time to accumulate data and to go to the authorities with very convincing data. That's the situation. I can tell you that the data that we have are very impressive, and this is why we do not want to give up on this drug because I do believe it's a very efficient drug in Fabry.
Thank you, Jean-Paul. Operator, do we still have questions in the roster?
We do. Would you like to take the next one?
Yes, please.
Thank you. The next is from the line of Peter Verdult at Citi. Please go ahead.
Sorry, I was on mute. Peter Verdult. Just a question, second question to André on the aprocitentan royalties. Could you characterize the level of interest that's been from parties, how many are in data room, and your level of confidence that a deal can be done before year-end? Maybe, for Jean-Paul, can you just reassure us.
The edema signal impression is going be considered as manageable, from a tox perspective. Thank you.
Jean-Paul, do you want to take also see his first question?
Yeah, I think it's. I have to say the edema signal is not. I would not discuss the word manageable. I think it's part of the treatment of these patients, and it's really not causing people to stop the treatment. I think we have a few. I think we can count basically on one hand the patients who had to stop because of that. I think that in this very severe patient, this is not going to be an issue.
Even more, I think that what we have observed and what is more important, that despite the very severe renal problem that these patients do have, we have not seen what I was really worried, and with everybody should be worried when you treat these patients, is the occurrence of acute renal failure. Because when you give antihypertensive drug in this very severe patient, this is a big risk, and we didn't see that. I think the safety is going to be not an issue. Of course, you know, every doctor will look always at these patients. But frankly, it is not to the point that it should produce stopping the treatment. That's the situation. I'm very confident.
You know, these are very severe patients on four therapies. What we have observed also is some very interesting indication on some renal function or renal damages. We have measured proteinuria. We have measured glomerular filtration. We have some very interesting data that will be shown later on, and which should reassure everybody using this drug. The other question, sorry, I forgot the other.
Just characterize the level of interest.
By Johnson?
No, by other parties in the royalty deal.
In the royalty deal. I think, as we said, we have many interests. You know, a deal is a deal, and until it's signed, it's not signed. I do not want to comment before we have the signature on this contract. Of course, we are working and André especially is working very hard. The data here, I think that what you have also to remember is that this protocol of the studies have been really suggested to us by the FDA. This is what they wanted to see in a drug in resistant hypertension. The fact that all the primary secondary endpoints are positive, the fact that this is a protocol really agreed with the FDA and basically suggested, you know, by them, and they had very good.
It was a very good idea, very good suggestion. I think we know that this drug really should be approved. I know that you always have to be very careful. We're working on the quality aspects and so on. We know that this drug should be approved on the merit of the clinical results. This is really making much easier our discussion with the potential royalty for royalty deals. Now we have the results, and we have been able to start the discussions.
Thank you, Jean-Paul. Thank you, Pete. Operator, do we have any questions left?
We do. Please stand by. The next question is from the line of Dominic Lunn from Credit Suisse. Please go ahead.
Thank you. Jo Walton again. I'm sorry to go back to QUVIVIQ, but this is a question about Europe. I understand you have the Syneos sales force as you have in the U.S. You have VitaCare as a distributor in the U.S. Is there any equivalent in any of the markets that you would use in Europe? Given that there hasn't been a DORA approved in Europe, how confident are you that you've got all of the data that you need to maximize the local reimbursement for those countries that will give reimbursement and that you won't have to do additional clinical studies? Question really is a degree of confidence in your knowledge about the 15+ markets in Europe versus the one market that you have in the U.S. Thank you.
Simon?
Okay, Jo. Just to be clear, VitaCare is not our third-party logistics provider. All the distribution of drug, they do some of that themselves, where our products just come in directly to VitaCare, and they can distribute directly themselves. We also have a 3PL in the U.S., which does the traditional distribution, and we have a 3PL in Europe that will do the same distribution throughout Europe. The actual patient service and co-pay model is not applicable to Europe just 'cause of the difference in the nature of the markets. Obviously we have all of the traditional distribution set up in Europe already. With regard to payer, yeah, no, we're confident we've got what we need.
A large part of that, as Jean-Paul said earlier, is because payers are starting to separate out chronic versus acute. Actually, I'll give you an example that you know, in our NICE submission and in our conversations with NICE in the UK, we have agreed that QUVIVIQ will not be compared to the Zeds and the benzos because the Zeds and the benzos are restricted to two to four weeks of treatment, and this is a chronic medication. By separating out as a chronic medication, you actually avoid the need to do these sort of head-to-heads. I'm not saying that's gonna be the case in every single market, but we're in a very good position to be able to use the difference in the labeling to separate out the comparisons as required.
Honestly, I think we're very focused on the top five markets. I mean, we talk. There are 15, and we can get to 40-something, but really the concentration of the opportunity sits with the big five markets and the addition probably of the Nordics.
Thank you.
Thank you, Simon. Thank you, Jo. Operator.
Thank you.
Next question.
Thank you. Please stand by. The next question is from James Gordon, from JP Morgan. Please go ahead.
Hello, James Gordon. Thanks for taking the follow-up question. It was just following up on the financing point. 'Cause my understanding before had been that plan A was the divestment of aprocitentan royalties. We've heard that it's not to do with the data or any approvability concerns. Is the challenge just that at this point, J&J hasn't said that much about their aspirations for the product, and that maybe a potential purchaser of the royalty would like to see not just the approval, but even how the launch is starting to go before they really want to commit to it? The other part of the question was just I heard sale and leasebacks mentioned. On the balance sheet, I think PPE is something like CHF 150 million.
Is that the part of the company that could be for sale or does that understate it? Is there more to sell than that?
On the latter part of your question, James, yeah, that's your ballpark. This is our buildings that we received from the merger process from Actelion back in 2017. On the first part, yes, J&J has not indicated much so far, except that back in November, last October or November, had an R&D day mentioning five drugs with the potential of more than $5 billion and nine, including aprocitentan, with a potential between $1 billion-$5 billion. Now, they've seen the data of the PRECISION trial and you know, it is a large company, so they wait for the results before really putting all the resources behind the potential launch. That's what we see now. Of course, you've not seen the full set of data.
It will be reserved for publication. Certainly, one of the scientific congress later in the year. I don't want to preempt Janssen's excitement around aprocitentan. As Jean-Paul said, with the data of the PRECISION trial, we are confident that J&J is the ideal partner to make aprocitentan a big success. I recall that most of the analysts see sales at peak north of CHF 2 billion. At CHF 2 billion, we would get CHF 550 million royalties. It's not tomorrow, that's for sure, with a drug that could be launched in 2024 in the U.S. and in other territories after. Each additional CHF 1 billion on top of the CHF 2 billion would be an additional CHF 350 million.
Aprocitentan for us and for return of royalty related deals was a key milestone to achieve. I'm not saying that the regulatory risk is off the table, but with, as Jean-Paul said, with a phase III, which was designed with the FDA and with all primary and secondary endpoints met with statistical significance, we are highly confident that the drug will be approved. J&J will launch it, and we have no doubt that we have an ideal partner here with Johnson. Just if I understand, James, you wanted to ask why does it take time? Was it one of your questions? Sorry.
Yeah.
Did I hear?
I think the initial, at least what I'd understood before, is that it sounded like it was very much the plan A was that it would be sold by the end of the year, but it now sounded like there were quite a few different options being entertained. My question was, if it's not the approvability and it's not the profile, which sounds like it's very good, why was it less than-
No, no, not at all. I think it takes, you know, time, and we want to have a good deal. You know, we don't make a royalty deal for several hundred millions. Of course, it is going to be a big deal. We want to go through a real good process, and we want to find the best offer, and we want to work on every single details of this offer. It takes time, but I think that there is nothing which is in front of us which would prevent us to do such a deal. Now we have the results.
Everybody is quite confident that this drug is going to get approved. No, there is no issue on this side. I repeat, you know, we do not want to get through dilutions, and we will use many approaches in order to avoid diluting the shareholders. We are working very hard and every day we are making progress, and before the end of the year we'll be there, I'm quite confident. We do not want to give up value too early, and this is a topic of André, to try the best deals of all what we do.
Makes sense. Thank you.
Thank you, James. Thank you, Jean-Paul. Operator, do we have any questions left? The time has advanced.
We do, and please stand by while we take the next one. Yes, it's from Rosie Turner from Jefferies. Please go ahead.
Hey, thank you for taking my follow-up question. So it just cropped up a bit earlier, André, when you spoke about what you needed to be able to see to give us some kind of guidance on QUVIVIQ, I guess for the remainder of this year. I just wondered what that was. Are we kind of waiting to see that DTC have an impact, I guess, at the beginning of September, so we can expect maybe a bit more guidance in Q4? Or is it something else that we just missed? Thank you.
No, it's really to see demand. Simon, I'm sure you can add to what we need to be more confident in the uptake beyond these preliminary weeks.
Yeah. I mean, Rosie, it really is for us to have some more time and see some more data points. I think momentum is good. You've seen the NBRx data, which is a critical lead indicator. Then we've got the DTC, as you mentioned, kicking in in sort of late August, September. I think once we start to see what the trajectory looks like thereafter, we'll be in a better position to have a view as to what that looks like.
Just, you know, I would like to say, as a CEO, and it's not self-congratulations, please believe me that we are all very focused on our task and on the challenges. You know, which company has built within five years a GP sales force in the U.S. and now in Europe? I don't think that has happened. Frankly, we have had at the first weeks, you know, it was not easy for us to go through the distribution channel. We were not a very big company compared to the big Merck or Pfizer of the world. Of course, we had to get the organization, the distribution system in place, the electronic systems in place, which is now in place. That's the first point.
The second point was really to inform the doctors. This is really what we have done. You have seen more than 50% of the doctors know about QUVIVIQ. They are testing it. Let's be clear. Even if they believe us, I think they still believe more in the things they will see by themselves. They are testing, most of them testing in a few of the patients, sometimes in a lot of their patients, but sometimes in one or two patients. What we have heard that they're very happy. This is a phase where the doctors are testing it. The real clear thing is that this market will take off only with DTC. Because today, doctors, as we say, have some other clear priorities.
They have the COVID situation, which was not anticipated. I frankly believe that the beginning of the year with vaccination going behind us. There is, as you have seen, quite a big number of patients who have COVID. Then when the patients will be able to really know about this drug and ask, this is going to make the difference. Already we are going to be the number one DORA very soon. Frankly, before being the number one, I would not hardly discuss with these payers. I want to be the number one to discuss. That's always a much better situation.
We are going to see the real impact of DTC during Q3, but even more Q4. I would say it's Q4, it's a Q4 issue. We will really be able to describe with you when are we going to plan for the payers to cover us, how much is the demand and what our expectation. This is really going to happen late this year.
Thank you, Jean-Paul.
If I may, Jean-Paul, I would add to your comments that sleep is, you know, it's a perfect world for a drug that works. We believe that QUVIVIQ has these key attributes. I hate parallels, but you know, look at the launch of Otezla back in 2014. You know, you need free sampling to build experience with the patient, the word of mouth, but also with the physicians, because if you get your strong feedback from a patient, this is what will drive a commitment. Now, Simon has shown that less than two months after the launch, we have already 62% awareness, which is already a significant percentage.
To your second part will be yes PBMs as Jean-Paul said and Simon said before. Well, there are some barriers and with strong demand we will get these PBMs on board but not at all costs. I hope we'll have the same profile in the U.S. as Otezla with Celgene and now BMS north of $3 billion. Look at the first quarters, it was really a slow uptake. Hope we'll do better.
Also just to add, sorry, because I think we forgot to mention it during this, or we didn't mention it as much as I think, is the importance of the 50 mg. 50 mg dose, which is really basically recommended in Europe and which is approved, and it was so important for us to have 50 mg. 50 mg gives a subjective improvement in the patient. We know it. Basically, a one-hour total sleep time, subjective total sleep time improvement. You know, 1 hour of sleep per day means a whole night of sleep at the end of the week. This is major, and this is really felt with the 50 mg more than the 25 mg.
This is why we are so happy, and we have to fight, and we are fighting that really, people, patients take the 50 mg dose, which is, certainly, the dose giving the best subjective effect without the price to pay, on the side effects. This is the indicator personally which I look the most, because if we would, be, having, 75% of the patients 25 mg, I think we would be in trouble because it would mean that the patients will not make the difference and will not tell the doctors what they do today. They tell the doctors, "God, I have not slept for such a long time, so well." This is because they feel it, this is a subjective, and this is a 50 mg.
We are working very hard on that, and I think this launch will be a success because also we are spending a lot of energy on this dosing recommendation.
Thank you, Jean-Paul. Okay, we've overdrawn over more than a half an hour. We need to conclude the call for today. On this, we're gonna thank everybody for their ongoing interest in Idorsia. Our next scheduled news flow will be the nine-month results on the 25th of October, but I'm sure before then we'll be talking again. Stay safe, everybody.