Idorsia Ltd (SWX:IDIA)
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May 13, 2026, 5:31 PM CET
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Earnings Call: H1 2023

Jul 25, 2023

Operator

Good day, and thank you for standing by. Welcome to the Idorsia half-year 2023 Financial Results Reporting Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you'll need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised today's conference is being recorded. I'd now like to hand the conference over to your first speaker today, Andrew Weiss. Please go ahead.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Sarah. Good afternoon. Good morning, all, and welcome to the first half conference call to discuss our reporting. With me on the call today are our CEO, Jean-Paul Clozel, and our Chief Financial Officer, André Muller. They're both here to give additional co-granularity to the reporting that we did this morning and will be hosting the prepared remarks. Further, we'll be hosting a Q&A session where our General Manager and President of the U.S. organization, Patty Torr, and our President of European and Canadian regions, Jean-Yves Chatelan, will be joining us. Next slide. As customary, before handing over the microphone, I need to remind everybody that we will be making forward-looking statements. You have therefore been appropriately warned about the risks and opportunities of investing in Idorsia shares. With that, I hand over to Jean-Paul. Jean-Paul, the floor is yours. Next slide.

Jean-Paul Clozel
CEO, Idorsia

Good morning. Good afternoon, everyone. Many things are happening today at Idorsia. We are working very hard with the FDA and the EMA to have Aprocitentan approved, today I will first focus on the society that we announced just last week, the cost reduction initiative, and then I will describe to you the progress we are making with QUVIVIQ. André will take you through our financial results. Next slide. Just last Thursday, we announced the sale of our operating businesses in the Asia Pacific, ex-China region, to Sosei Heptares, for a total consideration of CHF 400 million.

The transaction includes the acquisition of Idorsia affiliates in Japan and South Korea, the assignment of the license for Pival in the Asia-Pacific region, and the co-exclusive license for daridorexant in the region, together with the assignment of all potential milestones in connection with the license granted to Mochida. The transaction also includes an option for Sosei Heptares, upon payment of separate option fees, to license and for the development and commercialization in the territory. The transaction created value for both companies while maintaining our ability to develop our drugs for patients in the region. Importantly, it brought cash that has given us some breathing space to adapt our company. Next slide. In order to give us the time we need to realize commercial success, any funds that are secured must be prioritized for activities that maximize their return in the near term.

To this end, we are launching a cost reduction initiative with a target of reducing cash burn at headquarters by approximately 50%. This will then become fully effective in early 2024. I'm very sorry to say that in order to achieve the required savings, up to 500 position at headquarters, mainly in research and development, and the associated support function could potentially become redundant. The cost reduction initiative is dependent on the full portfolio review, potential out licensing deal, and an employee representative consultation in Switzerland. Since our immediate objective is to maximize the time the company has to deliver commercial success, now, let's take a look at the progress being made with QUVIVIQ. Let's start with a summary, next slide. Sorry, guys. Next slide.

Let's start with a summary of the US performance by looking at what has been achieved in the insomnia market and focus on the immediate priority for the team. Our approach at launch was to drive demand for QUVIVIQ. This was necessary for early product adoption and payer negotiation. In January, ESI added QUVIVIQ to the national preferred formulary. This was followed by CVS national coverage, as announced in July, which significantly increases affordable access to QUVIVIQ for the 20 million lives that CVS covers. To begin, QUVIVIQ is in tier 3, but we expect that QUVIVIQ will be in tier 2 at parity with the other orexin receptor antagonist by early Q4. As our access continues to improve, this means more prescription will be coming through the retail channel and will be paid prescription.

Now that we have the product demand and solid commercial coverage, we are moving away from the consignment model and accelerating our retail dispensing. You will see this in the next slide. We anticipate Medicare Part D access in Q1 2024. This would open 33% of the overall insomnia market, allowing us to compete more broadly in the entire market. The elderly population is also a very important patient group for QUVIVIQ, as the rates of insomnia are higher than in the general population, and our product efficacy and safety data is consistent in this population. Next slide. Let's look at the demand QUVIVIQ for QUVIVIQ. QUVIVIQ demand has continued to grow quarter after quarter since launch. There are about 60 in 2022, and there were about 65,000 QUVIVIQ prescription.

While in just the first half of this year, there were approximately 125,000 prescription dispensed, representing an increase of more than 85%. The right-hand chart is showing the channel where the prescription are dispensed. In the last quarter, we see a shift from a consignment model, which we used to drive demand to a retail model. This movement represents an important trend that we expect will accelerate as our market access position continue to grow and will enable us to pursue more paid scripts. Next slide. Importantly, we see our refills increase, validating that patients have a positive experience with QUVIVIQ. As insomnia is a chronic condition for many, strong refill rates are fundamental to positive patient outcomes and long-term growth of the product.

We will continue our educational efforts for both physicians and patients, specifically, we are working on setting the right expectation, really explaining to the patient that they have to take QUVIVIQ every night to get the maximum benefits. We are going to explain safety profile of QUVIVIQ, and of course, the specificity of the unique pharmacokinetic profile of QUVIVIQ. We continue to evaluate our sales force footprint. We have moved from approximately 400 sales representative at the start of the year to 325 as July 1st. As for of July 1st. We have now crossed 30,000 total writers of QUVIVIQ since launch.

While we have opportunity to further expand the number of new writers, we are focusing on transitioning current QUVIVIQ trialists to loyalists, driving more depth in prescribing. Next slide. Let's move to Europe and look at the great progress being made with the launch, or the launch preparation, as well as we securing access and reimbursement. As you know, we launched in both Germany and Italy in November 2022. In Germany, we are engaged with authorities in two parallel processes. First, the AMNOG pricing and reimbursement process for the first four weeks of treatment. We are expecting the outcome of this first negotiation by the end of the year.

In parallel, as you know, prescriptions of sleeping medication in Germany are limited to 4 weeks, there is a G-BA review to allow QUVIVIQ for chronic use, more than 4 weeks. We should hear about this process at the end of Q3 this year. If this 4 weeks limitation for QUVIVIQ is lifted, we plan to submit a second AMNOG dossier for the treatment of chronic insomnia beyond 4 weeks, reflecting the indication in chronic insomnia disorder granted by the MEA in 2022. In Italy, QUVIVIQ was launched in the self-pay market, noting that no sleep therapy is reimbursed in Italy, with prescription limited to neurologists, psychiatrists, and specialists from sleep centers. Reimbursement and general practitioner expansion dossier was submitted in Q2, 2023.

In Switzerland, the reimbursement dossier for QUVIVIQ was submitted in November 2022, and the review is ongoing. While we are waiting for the reimbursement, which is anticipated for the end of this year, QUVIVIQ was launched in the self-pay market. In the U.K., the NICE review is in progress, and we expect to launch QUVIVIQ by the end of 2023. In Spain, we will make QUVIVIQ available in the self-pay market, also by the end of this year. We are currently evaluating the best way to demonstrate the value to payers in this market. In France, the Transparency Commission recognized through an ASMR four rating, that QUVIVIQ brings an added value to the current treatment landscape of patients with a chronic insomnia.

After CBTI, for all patients who do not have access to CBTI, QUVIVIQ will be the only available and recommended treatment for chronic insomnia disorder. In France, in addition, with the rating of the clinical benefit, which has been granted by the Transparency Commission, this rating will lead the reimbursement without copay for 95% of patients covered by public and private health insurance in France. We anticipate the commercial launch in the first part of 2024. Last but not least, following approval by Health Canada in April, we plan to submit QUVIVIQ for reimbursement for, by private payers by the end of the year, with the commercial launch anticipated in the first part of 2024. Next slide. Let's look little closer to the demand dynamics in the European market.

After little more than 6 months on the German market, we are pleased to see a constant growing demand for QUVIVIQ. Our field teams, reps are calling on both the specialists and the primary care physician. We pay particular attention to the specialists, such as the sleep center, psychiatrists, neurologists, who have more time for their patients, and we can set the right expectation for gaining the best experience and the benefits of QUVIVIQ. This strategy brings greater depth of prescription, as well as more repeat prescription. We are also in Germany, building on the experience of the 20 expert centers, who have contributed to the enrollment of more than 800 patients in the registration study. Next slide. We see the same constant growing demand for QUVIVIQ in Italy after 6 months on the market.

Here we call on specialists only, and we are making sure to explain to these patients the benefits of QUVIVIQ, and really the need for chronic treatment. This is extremely important to have this explanation, since the drug is fully paid by the patient. We are happy with the engagement that our Italian team has been able to build with a community of specialists in such a short time. That brings me to the end of the overview, now I will hand over to André, to walk you through the financial. Next slide.

André Muller
CFO, Idorsia

Thank you, Jean-Paul. Good, good afternoon or good morning to everyone. As Jean-Paul alluded to it, you know, we're more than happy that we managed to close this transaction with Sosei regarding the APAC ex-China business, because it extends actually our runway to early 2024. To be very clear, we do not want to be in the same position, I would call it the back to square one, by the end of the year. To this extent, there are several initiatives which are ongoing to raise additional cash in each in the second half of 2023.

One of them, also Jean-Paul Clozel mentioned it, is to reduce our cost base. The reason for it is that we want that any amount of cash that will be raised needs to last longer moving forward in 2024. Next slide, please. We are on slide 14. Here you have the breakdown of the net sales over Q1 and Q2 for the first half. As you understand, the Tivla have still been consolidated, the $32 million sales because the transaction closed post......

Post the third year of Food, but moving forward, the whole business in Japan and South Korea will be deconsolidated, i.e., the net sales and operating expenses, and the corresponding financial and tax expenses relating to the APAC ex-China regions will no longer be reported in the P&L. They will be reported in a dedicated line on result from a discontinued operation, and of course, again, on these discontinued operations. Moving forward, what you will see, starting with Q3, for the first half, are only the QRV sales of $11.7 million. Next slide, please.

Here you see, and I will come back to the non-GAAP operating expenses, how the P&L came about, net revenues of $51.4 million sales because here people are included other contract revenue of $7 million. With the non-GAAP of $393, leading to a non-GAAP operating loss of $342, with the usual depreciation and amortization stock-based compensation. This leads to a US GAAP operating loss of $375, and below a bit, mainly a financial expense, you end up with a US GAAP net result of minus $405. Next slide, please. Not spending too much time on the OPEX.

You see here, how they compare to last year. As one could expect, research and development, we try to limit the OpEx, and we succeeded with EUR 54 million compared to EUR 60 million in the preceding H1 2022. EUR 99 million with the development and an increase in SCN, mainly driven by the US, but also with the launch or launch preparation across EU five, with for the first half, EUR 235 million. Next slide, please. Here, just to give you a sense of what is the scope we operate and how it will be reflected moving forward.

We have reported non-GAAP operating result of $342 million. If you exclude the $5 million positive impact of Japan and South Korea, it means that moving forward, the H1 non-GAAP operating results are or will be $346 million. If you exclude the DNA and share-based compensation, it will be $377 million. Next slide. Cash flow. As you know, we started the year with $466 million, and if we want to reconcile with the just non-GAAP operating results I showed previously, which includes Japan for $5 million. We've had significant working capital requirements, $70 million.

You will see a proceed from borrowings will come later on the CHF 30 million. Other items which led to a liquidity of CHF 33 million by the end of. Next slide, please. Coming to the liquidity, and this CHF 33 million. They include CHF 10 million, which was the payment made by Socei in June, at the signing of the non-binding term sheet, CHF 10 million, and also a CHF 20 million bridge loan funded by Jean-Paul Clozel.

It's a bridge loan of $75 million, of which we had first drawdown of the $20 million by the end of June, and which has been actually repaid last Friday when we got the additional payment from the closing of the Sosei Heptares deal of $386 million. It is a $400 million deal, and there will be an adjustment, normally within 90 days, for the closing. Around mid-October, where approximately, we should get ±$4 million.

What the liquidity does not include, what it excludes, is the cash held in Japan, $11 million, because this is reported in separate item by in our financial results, so-called asset held for sales relating to Japan and South Korea. Next slide. My last slide. Here, we want to re-enforce the operating guidance, $650 million non-GAAP, $735 million US GAAP operating loss. On the new scope of transaction, excluding the impact of the Sosei deal.

As you have seen, actually, we have spent $346 million in H1, so to achieve this guidance, it implies that we will spend less, around $300 million in the second half of 2023. As we say, I will hand over to Andrew again.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, André. We have come to the end of our prepared remarks and are ready now to take your questions.

Operator

Thanks, team.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Please play by the rule and ask only one question at a time, and then jump back into the queue. Operator, could you please queue the lines?

Operator

Thank you. As a reminder, if you would like to ask a question, please press star one and one on your telephone and wait for your name to be announced. To withdraw your question, you can press star one and one again. Star one and one to ask your questions. Thank you. We'll now go ahead with the first question. Please stand by. First question is from the line of James Gordon from JP Morgan. Please go ahead.

James Gordon
Executive Director and European Pharma Equity Research, JPMorgan

Hello, James Gordon, JP Morgan. Lots of questions I'll keep to 1, and I get back in the queue. There's a few different moving parts in terms of divestment, et cetera. As I understand it, you would still only have funding to take you through to early next year, and there was a comment about initiatives to extend the runway. Is that more likely to be divesting pipeline assets? Are you already in any discussions with anyone about divesting assets in the pipeline, or is it more likely that you would raise equity? What's the most likely there, and where are you with discussions and other avenues, please?

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, James.

André Muller
CFO, Idorsia

Yeah.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

On funding avenues, I think, André, you'd be best to address the, to address this.

André Muller
CFO, Idorsia

Yeah, I assume so. Thank you, James, for your question. Let me just give you some backdrop on what happened in Q2. Yes, we were able to close this transaction with Sosei. We were also ready to go for an equity raise just in case we would not be able to close the deal. Moving forward, yes, we have some ongoing discussions, first with the trio review, and that's ongoing discussion.

Meaning that, we will look for some potential partners on some of the pipeline assets. Hopefully, we have a fewer balls in the air, and hopefully, we'll be able to catch 1 or several. That's factor 1. As I told you know prospectus was ready, banks were appointed, lawyers were appointed. We, if need be, we will pull the trigger for an equity raise. I want to start, I was always in the same with the same objective, of course, obviously, not the case right now, but obviously not the case early at 2023.

I would like to start 2024 with cash covering the next 12 months cash burn. The cost reduction initiative, again, is important to the extent that any cash that we will raise, as I just said, will also need to last longer. It will be a combination. It's not one deal in isolation. It's several potential deals in connection with equity or equity linked deal with the cost initiatives and the portfolio review that hopefully will bring us there by the end of 2023.

James Gordon
Executive Director and European Pharma Equity Research, JPMorgan

Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, André.

Operator

Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

operator, next question, please.

Operator

Thank you. Yes, we'll move to the next question. Please stand by. This is from Peter Verdult, from Citigroup. Please go ahead.

Peter Verdult
Managing Director, Citigroup

Thank you, Peter Verdult, Citi. I'll keep to one as well. Jean-Paul, forgive the bluntness of the question, but as you said yourself in the opening remarks, you know, the viability of the Idorsia business model is brought into question in the absence of QUVIVIQ becoming a commercial success. I suppose my simple question to you is: Is there a point in time in, let's say, 2024, where you might consider alternative options for the group as a whole or U.S. interest in QUVIVIQ, whether you look for partners to bring on board. I just wanted to know if that is in your thinking at all at the moment. Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Pete. More strategy point of view. Jean-Paul, do you want to address that?

Jean-Paul Clozel
CEO, Idorsia

Yeah, exactly. Yeah. No, no problem. Yes, I think that we have a fantastic drug with QUVIVIQ. It's just the launch has happened, 1 year ago, more, just a little bit more than a year in the U.S. We are basically, in terms of prescription, we are nearly as many prescription as Belsomra, new prescription, at least, as Belsomra, which is 7 years. We need to transform the demand into sales and into revenues. It just has taken longer than what we expected, but we need to make... and I think we are on the track to make a QUVIVIQ a success. It just is a timing, and the timing has, of course, financial consequences that as had, as you have seen, that we have partially solved with society.

What you have to know, we have a 15-year patent life with this drug, which is exceptional. We need to grow this drug and to make it a success. Now, we have to be realistic with the timing, and of course, with André, with the group, we have to adjust our expectation for from the difficulties we are seeing on the market. The feedback is excellent, and I think in Europe, people will be surprised because the problem in Europe, once we will get reimbursement in countries like France, in England, in Germany, is going to be very different from the problem we are facing in the US, where the access has been an issue. I think that we need and we will make QUVIVIQ a success.

Now, we have also developing Aprocitentan, and we have many other assets. My question is really what for the other assets and Aprocitentan, of course, what do we do with these other assets? This is where more the strategic question will rely. What do we keep? What do we partner? Frankly, I think that as a six-years-old company, if Aprocitentan is approved end of this year, as it should be, I do believe that very few company within five years or six years, let's say, will have and if we count clazosentan, which has now been sold to Sosai. Within five years, as registered three drugs, this would have been a fantastic success.

We need to really benefit from this effort, and we need to find the financial solution to do it. I think that QUVIVIQ is an important asset and should remain an important asset for Idorsia.

Peter Verdult
Managing Director, Citigroup

Thank you. I'll get back to you. Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

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

Operator

Thank you. We'll now take the next question. Please stand by. This is from the line of Sachin Jain from Bank of America. Please go ahead.

Sachin Jain
Assistant VP, Bank of America

Thanks. My question is more on liquidity, if I may. That's for André. On the redundancy program, what's your best guess on what the cash severance charge would be? In typical programs, they're typically one times future savings, it implies sort of low hundred millions CHF and how that impacts the timing and size of any funding. That's my first question. My, my second one, if I may, just to follow on from James's, how close to the end of the year will you run pipeline monetization options before progressing with equity? Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Sachin.

André Muller
CFO, Idorsia

Yeah, Sachin, you've been less disciplined than Peter. You asked 2 questions, but I will answer both. You know, we have an ongoing consultation with the employees representative in Switzerland, so that's ongoing. The number of redundancy will also depend on this portfolio review that we are doing with Jean-Paul Clozel and the team. I would not expect a significant impact regarding a headcount for the year, 2024, second half of 2023, but more full effect starting at 2024. That's the first one.

To your point, the savings, yes, it's a fixed cost base. The we need to reduce the fixed cost base at headquarter, which is mainly in R&D, and also to a lesser extent, in the support functions, so GNA. It's also the portfolio review, and here, you know, either we find a partner, and there are some discussion ongoing. I do not want to account the my chickens before they hatch.

Let's see what comes out of this discussion, because the other way to reduce the cash burn, to find a partner, not so much with the upfront, but also taking over some cost, you know, to be for the asset in the phase 3. Mainly a scenario mode and set that as well. To the funding options, yes, we mentioned our licensing deal. We mentioned equity raise or issuance of a new convertible equity link. The other one, you're right, is or could be a royalty monetization type deals.

We're exploring all avenues right now, and we need to implement some of them into your course of the second half.

Sachin Jain
Assistant VP, Bank of America

Okay. Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, André. Thank you, Sachin. Operator, next question, please.

Operator

Thank you. We'll take the next question. Please stand by. This is from the line of Thibault Boutherin from Morgan Stanley. Please go ahead.

Thibault Boutherin
VP of Equity Research, Morgan Stanley

Yeah. Hi, thank you for taking my question. Just, could you have an update on the situation right now for Lucerastat? What is the next step that will allow you to make an assessment on this one, please?

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Thibault. Jean-Paul, do you want to take that one on Lucerastat?

Jean-Paul Clozel
CEO, Idorsia

Yeah. I think Lucerastat, we are just going just a minute. Okay. For Lucerastat, you know, we are in discussion with the FDA to find a solution because we have very interesting results, and we are in discussion. It's not yet decided, so what we do. In Japan, as you have seen, I think that Sosai, and I cannot speak in their name, but we had we were in discussion with the Japanese authority for Japan. I think that this is what is ongoing. Of course, if we do not find a solution for Lucerastat, we might partner it, and I think there have been some people interested in Lucerastat.

This is a very active drug. Unfortunately, I think we didn't have a positive, a primary, the primary endpoint was not positive in our study. We will see, but I'm convinced that Lucerastat is a very good drug. But I can tell you, we will not spend ourselves. If we don't find a solution with the FDA, we are not going to spend more money, but rather maybe partners is growing.

Thibault Boutherin
VP of Equity Research, Morgan Stanley

Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

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

Operator

Thank you. We'll now take the next question. Please stand by. This is from Rajan Sharma from Goldman Sachs. Please go ahead.

Rajan Sharma
Executive Director and Pharma & Biotech Equity Research, Goldman Sachs

Hi. Thanks for taking my question. Just on the cost reduction, at the minute, it feels like it's kind of focused on R&D and headquarters. Just thinking about the level of investment behind QUVIVIQ, is there anything that you could do there? I guess, at what point would you think about kind of rightsizing the investment if you don't see the inflection in the revenue trajectory?

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

André, do you wanna take that question on cost savings beyond the announcement of Friday?

André Muller
CFO, Idorsia

Yeah. I'm volunteering, Andrew, for the, for it's a very good question. I just came two weeks ago. I was actually in the U.S. discussing with Patty and the team. There are a lot of initiatives ongoing in the U.S. also to adapt the model converting free prescription into a sales. You're right. You know, on one side, we need a few or more quarters to see the uptake because it's less than, well, it's 12 months since the launch with limited coverage.

Again, CVS will really kick in only in September with a tier two, i.e., at parity, but with the BELSOMRA, no priors, no step edit. Of course, we submitted the bids to for Medicare Party. We'll, we should hear in the next few months from CMS and hopefully get Medicare Party coverage, which is a significant chunk of the volumes of the insomnia market in U.S. in Q1 2024. It's a question of time and money because it's a primary care drug.

Time and money are two resources, which are obviously scarce, very scarce at Idorsia right now. We want to remain nimble and to be able to adapt, to the situation, not only in the U.S., it's the same in Europe. By making sure we have the right balance between how much we invest and what we can expect in terms of volumes, but volumes converting into a net sales.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, André. Operator, next question, please.

Operator

Thank you. We'll now take the next question. Please stand by. This is from Brian Balshan from Jefferies. Please go ahead.

Speaker 13

Hey, thanks. Just in terms of QVIVIQ success, it looks like you've got better conversion from confinement to paid scripts. You said QVIVIQ should be in tier two, early 4Q. Isn't it still the case that treatment naive patients have to go through a benzo or Z drug prior to DORA? If so, do you see it as a block? [inaudible]

André Muller
CFO, Idorsia

Hello?

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Brian?

André Muller
CFO, Idorsia

We lost Brian Andrew.

Operator

Brian Balshan from Jeffries, your line is open. We lost your line there. If you could please ask your question again. It looks like the line has disconnected. Should we move to the next one?

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Yes, please.

Operator

Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

We'll take him later.

Operator

Thank you. Your next question is from the line of Harry Sefton from Credit Suisse. Please go ahead.

Harry Sefton
Equity Analyst, Credit Suisse

Brilliant. Thanks. Just back to the cost savings. To what extent do you think you can achieve part of the cost savings through out licensing your late stage assets? Maybe to put another way, what percentage of your cost savings could you achieve from out- licensing, Cenerimod and selatogrel? Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

André, do you want to take that question on distribution of savings?

André Muller
CFO, Idorsia

Yeah, happy to take the question. It's a premature, Harry, to figure out what we can do, because by your definition, getting a collaboration or partnership or out licensing requires to see two parties. So we're to get both. If you're looking at the non-GAAP OpEx in H1, we have $362 million, if you exclude the Japan. Okay? $185 million in commercial, and we will address it. $144 million in R&D, of which two-third, roughly, is a fixed cost base, and one third is study costs. As a remainder, it's around $33 million, so H2 GNA.

Of course, we need to work on all levels, i.e., headcount, so fixed cost base, and hopefully, get some good partners for some of the assets. Right now, it's premature to speculate of what can be the outcome also on the headcount, because it also depends on the ongoing consultation with the employees representatives.

Harry Sefton
Equity Analyst, Credit Suisse

That's very helpful. Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, André. Thank you, Harry. Operator, do we have any more questions?

Operator

We do. Please stand by for the next one. Next question from the line of Stefan Schneider from Vontobel. Please go ahead

Stefan Schneider
Managing Director, Vontobel

Yes, thank you for taking my questions. My question is, why the scripts There is no inflection point, for instance, as the CVS deal in spring or in January, beginning of the year. It seems like it's a continuous linear increase, but no inflection point. Can you elaborate on why that is and what to expect from CVS?

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Stefan. Patty, do you want to take the question on how you see the inflection points and how these additional insurers pull through, and how does that generate in volumes?

Patty Torr
General manager and President of the U.S. Organization, Idorsia

Great. Thanks, Andrew. I think maybe first we had ESI in January, right? Just to qualify, I think you said CVS. As you're aware, just removing the NDC blocks does not provide immediate access for patients to get a covered prescription. The payers deny access unless a patient fails one or in some cases, two generics within a 180 day look back period. We are seeing within our book of business with ESI, in particular, since they've come on board in January, the conversion of consignment to paid scripts. We believe that will continue. Now, if you look forward to our current situation with CVS, as noted in July, the NDC blocks were removed.

Then in, as André and Jean-Paul mentioned earlier, later this quarter or early Q4, we will be moving into a tier 2 position, consistent with the other branded competitors, in the door class. It is an inflection point of paid scripts that we believe will continue, and our sales force is focused on pulling through these ESI and CVS wins. Okay, thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Patty. Operator, next question, please.

Operator

Thank you. We'll take the next question. Please stand by. Next question is from the line of James Gordon from JP Morgan. Please go ahead.

James Gordon
Executive Director and European Pharma Equity Research, JPMorgan

Hello, James from JP Morgan. Thanks for taking this question. Just continuing the theme on QUVIVIQ. If I understood correctly, you've made some real progress with coverage, but you don't see a benefit immediately when that product. Am I following correctly, that really it's not that Q3 or Q4 we should expect to see a big inflection? It's really more like Q1 is where you'd expect to see the inflection coming through.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, James. Your line was a bit breaking up there. I understood that your question is going in the direction is: when do you think that the inflection point is to happen? Does it happen already with CVS, when it passes September and is at eye level with Belsomra? Patty, do you care to elaborate on that, please?

Patty Torr
General manager and President of the U.S. Organization, Idorsia

Sure. Thanks. Thanks, Andrew. First, aligned to our demand-driven strategy, as you have seen, QUVIVIQ continues to grow quarter-over-quarter, with the latest quarter being 23% increase over the prior quarter. Market access has been a primary factor why physicians have said they will wait to write the product. With increased coverage now with CVS, we believe it will send a strong message to physicians, increasing their willingness to write QUVIVIQ, converting to paid scripts, we believe this will translate into continued growth. As of today, we have 63% of all commercial lives covered, we continue to engage with all payers, both in the commercial and Part D spaces. As was mentioned earlier, we anticipate Medicare Part D coverage in January 2024.

We have begun to see a switch from consignment to retail, with the opportunity to realize more insurance-paid scripts, and we believe this will accelerate as our access continues to improve. Our co-pay programs will also be aligned to our strategy to drive and shift away from the consignment model to retail. As I mentioned earlier, our sales organization is very focused on pulling through ESI and CVS wins, and we anticipate this to continue to drive quarter-over-quarter growth.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Patty. Operator, next question, please.

Operator

Thank you. Thank you. Just as a reminder, if you would like to ask a question, you can press star one and one on your keypad. Thank you. We'll now take the next question. This is from the line of Peter Verdult from Citigroup. Please go ahead.

Peter Verdult
Managing Director, Citigroup

Yeah, thanks. Pete Verdult, Citi. Patty, sorry, just to labor the point, just a repeat of James' question. I mean, when you put everything together, what's your best guess, when you think we'll see this in revenue inflection on QUVIVIQ? Maybe just another way of thinking about it, I think the run rate right now is about, what, $8 million a quarter. If the current scripts were under a successful retail model versus consignment model, what would the revenue uplift be if that was the case? Can you give us some ballpark feel of the true underlying revenues that would be under that sort of scenario? Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Pete. Patty, do you care to elaborate a bit more on what your expectations would be on volume? I don't think that we should go on, beyond in giving revenue guidance at this point in time.

Patty Torr
General manager and President of the U.S. Organization, Idorsia

Yeah, I think, thank you, Andrew, for the, and Pete, for the question. I do believe we will continue to see our volume growth again with the NDC blocks coming off for CVS in July and then a tier two position with CVS in September will help drive and be able to realize insurance paid claims. Another significant milestone we anticipate is the Medicare Part D in January of 2024. I think, you know, I think those are inflection points. We have various models of what that looks like, but while that's happening, we are winding down our consignment model, our free drug model program and co-pay program and offering.

The combination of the enhanced coverage for paid claims, as well as the winding down of the consignment model, will help accelerate, we believe, our quarter-over-quarter growth.

Peter Verdult
Managing Director, Citigroup

Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Pete. Thank you, Patty. Operator, next question, please.

Operator

Thank you. We'll take the next question. Please stand by. This is from Sachin Jain, from Bank of America. Please go ahead.

Sachin Jain
Assistant VP, Bank of America

Thanks very much. Just another one back on funding for Andre. I want to just go back to the pipeline monetization. It seems like selatogrel or cenerimod sort of partnering, the most advanced options. Why don't you just give us a bit more color on that, as to how long discussions have been ongoing, whether the three chats that you have more than one party at the table, and between assets, do you have a higher confidence in one versus the other? What I'm just trying to get a sense of with those questions is, were those discussions ongoing pre the sale of the APAC business, or they started post that? Because part of the monetization has been a topic for quite a long time now. Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Sachin.

André Muller
CFO, Idorsia

Yeah.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

André, yeah, do you want to offer any additional granularity?

André Muller
CFO, Idorsia

Sachin, I'm afraid I will disappoint you with my answer. Contrary to what we did with the undisclosed party for the APAC business ex China. Here, I don't want to speculate on the outcome of the ongoing discussions. We have a few balls in the air. We'll see if we manage to catch one, but we will announce it once we have a deal that will close. Yes, working hard, I am not speculating whether, you know, we're giving a probability of success because at the end it's a binary. Either it's a 1 or it's a 0.

Sachin Jain
Assistant VP, Bank of America

Okay, fair enough. Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, André. Thank you, Sachin. Operator, next question, please.

Operator

Thank you. There are no further questions at this time, so I will hand back to Andrew now. Thank you.

Andrew Weiss
SVP and Head of Investor Relations and Corporate Communications, Idorsia

Thank you, Sarah. Okay, we're just about at the top of the hour, so very convenient. Thank you very much for your ongoing interest. This will conclude our webcast for today. Operator, you may close the lines.

Operator

Thank you. This does conclude the conference for today. Thank you for participating, and you may now disconnect. Speakers, please stand by.

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