Good day, and thank you for standing by. Welcome to the Idorsia full year 2025 financial results conference call and webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be the question- and- answer session. To ask a question during the session, you need to press star one one on your telephone keypad. You will then hear an automatic message advising your hand is raised. To withdraw a question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, Srishti Gupta, CEO. Please go ahead. Thank you, Nadia. Good afternoon, good morning, everyone, welcome to our webcast to discuss the financial results of 2025. My name is Srishti Gupta. I'm the CEO of Idorsia, I'll start the call today with an overview of the operational progress we made in 2025, the exciting plans we have for 2026. I'll hand it over to Arno Groenewoud, our CFO, to walk you through the company's financial position. We'll take your questions. Next slide, please. The information presented today contains forward-looking statements that involve known and unknown risks, uncertainties, and other factors. These may cause actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. Next slide, please. We entered 2025 facing significant financial pressure, we leave the year stronger and more focused. 2025 was a year of stabilization and preparation. We reinforced our balance sheet, delivered disciplined commercial execution, and positioned our pipeline for decisive milestones ahead. Most importantly, we continued advancing medicines that address meaningful unmet needs for patients. Our Idorsia-led QUVIVIQ sales for 2025 have more than doubled compared to 2024, rising from CHF 60 million to CHF 134 million, just above our target, which we upgraded in May last year. This performance was a result of strong commercial traction and growing demand for QUVIVIQ in Europe and Canada. The stabilization and optimized model in the U.S. I will share more on this later. Our non-GAAP operating results have improved from a loss of CHF 308 million to a loss of CHF 100 million. Key to this operational recovery has been our commercial strength, paired with cost control. Arno will share more on our financial performance later. Next slide, please. Idorsia represents a rare combination of valuable assets. We are a commercial-stage pharma company with two products that have blockbuster potential. We also have a rich pipeline of first or best-in-class medicines. We have a clear path to making QUVIVIQ the standard of care in insomnia. In parallel, we are actively engaging in partnership discussions to maximize the value of TRYVIO/JERAYGO and change the treatment landscape of uncontrolled hypertension. We also have plans to advance our innovative pipeline, leading where we can and partnering where we should. Next slide, please. Let's start with QUVIVIQ. As you know, QUVIVIQ is a best-in-class dual orexin receptor antagonist. It works by suppressing an overactive wake signal rather than sedation, as some older drugs tend to do. As a result of this mechanism and the best-in-class pharmacokinetic properties, we can confidently say that only QUVIVIQ offers restorative sleep and revitalized days. Before we talk about the commercial performance of QUVIVIQ, it's important to ground ourselves in the patient experience of insomnia. Insomnia is not just the loss of a night's rest, and it does not end when the night is over. It infects the entire next day. Patients describe difficulty focusing, feeling emotionally depleted, and struggling to keep up with work and family responsibilities. What they value most is a treatment that helps restore their ability to function during the day. That next-day benefit is what matters to patients, and it's central to how we think about addressing this condition. Next slide, please. We continue to expect sales growth of QUVIVIQ in 2026 as we guide to sales of around CHF 200 million. This is just a step on our path to changing the treatment landscape and becoming a global blockbuster. We have a clear plan to achieve this. First, market expansion in Europe and Canada. Second, unlock the true value of QUVIVIQ in the U.S. Third, continue to build a global brand. Let's look at the progress we are making on this and what's ahead. Next slide, please. In Europe, QUVIVIQ is the only pharmacological treatment for long-term management of insomnia disorder. Our three-pronged approach to market expansion in Europe and Canada is proving very successful. First, we secure public reimbursement. Second, we invested focused promotional efforts targeting psychiatrists, neurologists, and sleep specialists. Finally, we expand into primary care with co-promotion partnerships. Starting 2025, we had secured reimbursements in France, Germany, the U.K., and the private insurance markets in Switzerland and Canada. We continued to focus on reimbursement, and during the year we obtained public reimbursement in Austria, successfully negotiated premium reimbursed price in Germany, entered price negotiations in Quebec while submitting in Finland and continuing our discussions in Spain. This continues to be our top priority for additional markets, and in 2026, we expect to secure public reimbursements in Spain, Finland, and Quebec while preserving our price corridor, submit in the Republic of Ireland and continuing discussions in Sweden, Italy, and the rest of Canada. Our promotional efforts targeting psychiatrists, neurologists, and sleep specialists are leading to strong positioning in retail and hospital settings. We've expanded into primary care with co-promotion partnerships with Menarini in France in October 2024, and Germany in April 2025, and in February 2026, we added the U.K. This is having an incredible effect on our reach, and we continue to look for partners who have established presence and relationships with GPs in other countries. The results of these efforts has been an outstanding trajectory, particularly in France, but closely followed by Germany, the U.K., and Switzerland when considering their relative market sizes, and that trajectory can continue. Just to highlight a few markets, demand in the final quarter of 2025 increased by 25% in Germany, 38% in Canada, and 45% in the U.K. Next slide, please. In the U.S., in 2025, we executed a targeted digital marketing strategy with Syneos Health to stabilize sales and maintain our core patient base. Going forward, ensuring more patients have access to QUVIVIQ remains a priority. To achieve this, we are advancing three key initiatives. First, descheduling the DORA class, recognizing the safety in the same way as it is recognized in all other countries. This would simplify prescribing, facilitate access, expand the prescriber base, and improve the patient experience, especially with regards to refills. Second, we will conduct a streamlined label-enhancing clinical study, agreed with the FDA to have QUVIVIQ's benefits on daytime functioning recognized in the U.S. label. In the same way as it is recognized in all other countries. This would reinforce our differentiated profile with physicians, patients, and payers. Third, we will be launching a direct-to-patient digital distribution model aligned with the evolving U.S. market and to increase access. Next slide, please. In 2025, we continued to expand QUVIVIQ's global reach and change the standard of care for insomnia with new approvals, launches, and strategic commercial partnerships. Several license agreements help cover markets shown here in green. QUVIVIQ is available in Japan through our partner, Nxera, and they recently saw positive phase III results in South Korea. Our partner, Simcere, has had a very strong uptake in China within the private setting, with 300,000-400,000 patients treated within the first 6 months. In June, we signed a licensing and supply group with CTS in Israel, more recently in 2026 with EMS in Latin America. In Brazil, the regulatory dossier has been submitted to Anvisa, marking an important step forward towards market entry in that region. In red, you can see the next wave of planned distribution agreements focused on Central and Eastern Europe, as well as the Middle East and North Africa. These partnerships are part of our strategy to broaden geographic reach efficiently. We expect to make further progress through mid-2026. We'll keep you updated as these agreements are finalized. Next slide, please. In 2025, we completed the recruitment into our pediatric study of daridorexant, enrolling children aged 10 - 18, with data expected in early Q2 2026. This will be an exciting readout that can pave the way for the first therapeutic option for children suffering from insomnia. Pediatric insomnia is a major unmet need, with an estimated 12 million children in the U.S. affected and no FDA-approved therapies available. Insomnia is more prevalent in children with neurodevelopmental disorders like autism spectrum disorders and attention deficit hyperactivity disorder. Our study includes these patients. Daridorexant is the only DORA in pediatric development. As the new standard of care, could revolutionize the treatment paradigm. We are particularly excited to share the results in the coming weeks and discuss the path forward with regulators. Next slide, please. Our second approved product is aprocitentan, commercially available under the trade name TRYVIO in the U.S. and JERAYGO in E.U. We secured regulatory approvals in the U.K., Switzerland, and Canada during 2025. It is the first and only endothelin receptor antagonist approved for the systemic hypertension market. We are actively engaged in partnership discussions, evaluating global and regional deals. Our objective is to expand access for patients while creating value for all stakeholders. Next slide, please. TRYVIO/JERAYGO, is uniquely placed in the treatment landscape for difficult-to-control or resistant hypertension. Its efficacy and safety profile differentiates it to existing therapies and any of those in development. Our registration trial, PRECISION, remains the only hypertension study to enroll true resistant hypertensive patients, all on three, four, or more drugs when entering the study. Notably, there was no exclusion based on any antihypertensive drug class. It also had the broadest inclusion criteria, including patients with eGFR as low as 15. Aprocitentan delivered a double-digit blood pressure reduction of 15.4 mm of mercury in just four weeks, on top of a standardized triple therapy administered as a fixed-dose combination pill. Aprocitentan has an excellent safety profile, with low discontinuation rates observed over 40 weeks, no drug-drug interactions, and no increased risk of hyperkalemia, hypotension, or a decline in eGFR. The FDA-approved approval provided a broad U.S. label that indicates TRYVIO is suitable for use in all patients who are not adequately controlled on other therapies, with the cardiovascular outcome benefits cited within the indication statement. TRYVIO benefited from several important de-risking milestones in 2025. In March, the FDA removed the REMS requirement, simplifying prescribing and distribution. In August, aprocitentan was incorporated into the updated comprehensive hypertension guidelines issued jointly by the American College of Cardiology and the American Heart Association, which was an important step in reinforcing its role in clinical practice. Our recently published CKD subgroup data shows strong blood pressure lowering plus significant reductions in proteinuria, supporting TRYVIO as a compelling and differentiated option for these patients. Market access work for JERAYGO is also underway in Europe to support our partnering efforts. Next slide, please. TRYVIO is currently being prescribed at more than 25 of the top hypertension centers as part of our focused pre-launch activities to generate on-market experience. In the clinical setting, we see consistent double-digit blood pressure lowering across subgroups, including CKD stages three to four, with excellent safety and tolerability. We see prescriptions coming from key specialties, including nephrology and cardiology. Early on-market experience is translating into increasing new patient starts and improving refill rates, reflecting growing physician confidence in the therapy. Prescribers report meaningful and reliable blood pressure control and comfort using TRYVIO across diverse comorbid patient types. TRYVIO's early real-world experience confirms and reinforces the pivotal trial data from PRECISION. Next slide, please. Our U.S. label allows us to target patients with uncontrolled hypertension despite treatment on two or more therapies. Within this broad patient population, there are clear and identifiable patient subgroups that would be the natural initial choice for prescribers. These include patients who remain uncontrolled despite treatment with three or more therapies, truly resistant hypertension by definition. This is a group with significant unmet need and high clinical urgency. Second, patients with uncontrolled hypertension and comorbidities where endothelin is known to play a role, such as diabetes and obesity. Third, there is a clear need among patients with uncontrolled hypertension and chronic kidney disease, including those with eGFR down to 15. In this setting, TRYVIO offers a differentiated option without the hyperkalemia risk or eGFR decline that often limits other therapies. Importantly, our on-market experience shows strong uptake across these same patient segments. Notably, given the significant unmet need and clear medical value in these patient populations, the prior authorization process has been very smooth. Next slide, please. Let's turn now to our pipeline. 2025 was a year of meaningful progress, laying the foundations for long-term growth. We are making deliberate, focused investments to accelerate our most value-creating assets, supported by a leaner and more streamlined R&D organization. We have advanced our first-in-class immunology portfolio of three chemokine receptor antagonists. The study for our CCR6 receptor antagonist is already enrolling in psoriasis, with broad potential in T helper 17-driven autoimmune disorders. A study to show anti-inflammatory and remyelinating properties of our CXCR7 receptor antagonist is in progress, progressive multiple sclerosis will start shortly. A study for our CXCR3 receptor antagonist as an oral precision treatment for vitiligo will begin later in the year. Each will be a proof of concept in the specific indication under investigation, as well as a proof of mechanism for a range of related disorders. Next slide, please. We recently announced the exciting news that we have established a clear route to registration for lucerastat in Fabry disease. Fabry disease is a serious and progressive condition affecting around 16,000 people today, a number expected to rise to 21,000 by 2034. There is a high need for treatments capable of addressing disease biology across the full Fabry population, as existing therapies are partially effective, have cumbersome intravenous administration, or are limited to specific mutation types. Lucerastat's mutation-independent mechanism, oral delivery, and long-term data make it uniquely differentiated option in a market expected to reach $4 billion. The body of evidence we have generated to date shows that long-term treatment with lucerastat consistently reduces the glycosphingolipid substrates that accumulate in Fabry disease. We also observe a slower decline in kidney function compared with patients' prior historical trajectories. Importantly, kidney biopsy data from patients receiving long-term treatment demonstrate low to no levels of characteristic lysosomal deposits, per our related data recently published at WORLDSymposium 2026. Next slide, please. Following constructive interactions with regulatory authorities, we now have a clearly defined clinical program for lucerastat. This program builds on the substantial body of data already generated and outlines the agreed path towards future NDA in the U.S. and in line with feedback from the European Medicines Agency. The agreed development plan includes a pivotal baseline controlled biopsy study, supported by a second study designed to demonstrate that an oral therapy has the potential to deliver clinical benefits comparable to enzyme replacement therapy, which is complex and burdensome for patients. This developmental program is structured to reinforce the lucerastat's potential as the first oral monotherapy suitable for all Fabry patients, regardless of mutation type. If successful, the data are expected to support regulatory submissions as early as 2029. With that, I will hand it over to Arno to take you through the financial results and our guidance for 2026. Next slide, please. Thank you, Srishti. Good afternoon, good morning to everyone on the call. In my first slide, you can really see the impact of our increased QUVIVIQ sales and contract revenue, together with our cost-saving measures, resulting in a significantly improved operating result. Net revenue of CHF 214 million includes CHF 134 million from QUVIVIQ product sales, excluding partner sales. A significant increase compared to the CHF 61 million of sales in 2024. The main driver of the sales increase is the EUCAN region, where sales increased from CHF 32 million - CHF 108 million. The sales in the U.S. remained flat, despite a significant reduction in sales and marketing costs. As mentioned by Srishti, the aim is to maintain our U.S. prescriber and patient base in a cost-efficient manner to bridge to a potential descheduling. Non-GAAP contract revenue of CHF 72 million includes the $35 million exclusivity fee from the undisclosed partner for aprocitentan that was received in Q4 2024, but recognized in Q1 2025, after the exclusivity period ended without resulting in a deal. A reminder, the undisclosed partner was not able to close the deal for reasons absolutely unrelated to aprocitentan. In addition, we received a CHF 40 million signing and approval milestone from Simcere, related to the out licensing of QUVIVIQ in China. The cost rationalization efforts initiated in 2024 and 2025 further improved our operational cost base, with savings of more than CHF 80 million compared to 2024. As a result, the non-GAAP operating results improved from a loss of CHF 308 million in 2024 to a loss of CHF 100 million in 2025. Based on successful negotiations with Viatris in Q1 2025, Idorsia's cost-sharing commitments were reduced by $100 million against a reduction of potential future regulatory milestones. This resulted in a gain of CHF 90 million. Other non-GAAP to GAAP differences mainly include depreciation and amortization and stock-based compensation. This resulted in a U.S. GAAP EBIT loss of $33 million. The U.S. GAAP net loss of $112 million also includes the financial expenses of $72 million, which also includes a $61 million non-cash expense related to the convertible bond restructuring and the new money facility. We had an income tax expense of $6 million. Next slide, please. In addition to an outstanding operational performance in 2025, we were also able to successfully strengthen our financial position and access to liquidity. As you know, we started the year with CHF 106 million in cash. Operational cash inflows included CHF 142 million from QUVIVIQ product sales, including sales to partners. Operational cash outflows included CHF 250 million of SG&A and CHF 93 million of R&D costs. The CHF 11 million other cash outflows mainly included working capital movements. As announced in May 2025, we secured a CHF 150 million funding facility from our bondholders, and in June 2025, we drew the first tranche of CHF 70 million. We also raised CHF 68 million, net of cost, through an equity raise in October 2025 by way of an accelerated book building process, as well as the sale of some of our treasury shares to bondholders. We were very happy with the oversubscribed demand from the top-tier institutional investors that participated in the book-building process. This resulted in a liquidity of CHF 8 million at the end of the year, and in addition to that, we still have access to a further CHF 80 million from the new money facility, which totals CHF 169 million liquidity available to Idorsia. All in all, I think we can conclude that we finished the year with a strong liquidity that puts us in a good position to fund our activities going forward and leading to next inflection points. Next slide, please. Here we go into the comparison against the guidance. We are proud of our strong performance against an ambitious guidance target, which was significantly upgraded in May 2025. Our QUVIVIQ sales of CHF 134 million exceeded the guided sales of CHF 130 million due to an excellent execution of our commercial strategy, as Srishti already alluded to. The company also delivered on the announced reset of the cost base. As a result, the operating expenses, net of other income, were in line with the guidance that we provided in May 25th. The U.S. GAAP loss of CHF 33 million is lower than the guidance, mainly due to one-off lower stock-based compensation costs. Equally important, compared to achieving the financial guidance for 2025, is that we've built the structures to transition this momentum into the future. Next slide, please. We continue to guide on Idorsia at sales, excluding sales to partners, because this is the performance that we can actively steer and have control over. We expect a continuous QUVIVIQ sales growth. With sales of CHF 200 million, we will have a positive commercial contribution for the first time. Our 2026 OpEx, including cost of goods sold, will be flat compared to 2025. A little bit higher than might be anticipated in the market, purposefully so, focused on creating shareholder value and within strategic guardrails. Our 2026 OpEx is fully consistent with a disciplined plan that supports the next wave of growth drivers. These expenditures are targeted, program-specific, and clearly tied to our medium-term value creation plans, such as lucerastat program and the proof of concept studies with our immunology portfolio. In a nutshell, sales are going up, OpEx remains flat, and overall losses are going down, reflecting the improved underlying business performance and the embedded operational leverage within our business model. With that, I hand over to Srishti. Next slide, please. Thank you, Arno. 2026 is shaping up to be a catalyst-rich year across commercial execution, strategic partnering, and important scientific readouts. We are particularly looking forward to sharing the pediatric insomnia data in early Q2, along with several additional milestones throughout the year that we believe have the potential to meaningfully advance our portfolio and create value for shareholders. Next slide. With two approved products with significant commercial potential and a pipeline of first and best-in-class compounds, Idorsia is positioned to create meaningful value. I am proud of the team's performance in 2025. We delivered on upgraded, ambitious guidance, accelerated QUVIVIQ's commercial trajectory, and continued building the foundation for long-term growth. TRYVIO/JERAYGO represents the fourth endothelin receptor antagonist brought to approval from our pipeline, underscoring our deep expertise in this pathway and its potential in an area of high unmet need. We continue to advance other assets with discipline and focus. As we look to 2026, we are committed to executing against even more ambitious objectives with a clear focus on delivering sustainable growth and long-term value. With that, Nadia, please open the line for questions. Thank you so much. Dear participants, as a reminder, if you wish to ask a question, please press star 11 on your telephone keypad and wait for your name to be announced. To withdraw a question, please press star one and one again. Please stand by, we'll compile the Q&A roll studies. Will take a few moments. Now we're going to take our first question. It comes to the line of Raghuram Selvaraju from H.C. Wainwright & Co.. Your line is open. Please ask a question. Thank you so much for taking my questions. Firstly, I was wondering if you could elaborate a little bit further on the digital distribution model for QUVIVIQ, and specifically, A, how you anticipate this to have an impact on the forward sales trajectory? B, how it might improve your operating efficiency going forward, and C, how it could conceivably be leveraged for the use of launching additional products in the future, or if it's going to be very specific to the needs of QUVIVIQ as a product franchise and wouldn't be applicable necessarily to other potential products that you bring to market in the future. Secondly, I was wondering if you could provide us with kind of what you see as the ideal timeframe within which you would want to have a TRYVIO/JERAYGO partnership in the United States, as well as regarding guidance, just some clarificatory points. Are you still confident in the previous 2027 top-line guidance, or how has that changed? Are you including in that forward assessment any potential contribution from TRYVIO/JERAYGO, or is that going to be entirely driven by organic growth in the internal products over which you maintain commercial control? Thank you. Thank you, Ram. The first question area we can tackle first on the distribution model that we're thinking about for the U.S. for QUVIVIQ. Is that, is that the first question area? Yeah. We're thinking, I mean, what we've learned from the weight loss space is that when there's a high degree of self-diagnosis, the ability to then find a provider and find, be able to go to online, to broaden access and broaden the availability to patients, that can have a huge unlock for certain therapeutic areas. We very much believe that sleep could be the next therapeutic area that could benefit from this type of model. We've been exploring right now in the U.S., how we could do a direct-to-patient distribution model for QUVIVIQ. We've heard, you know, this is a friction right now in terms of both on the prescriber side as well as on the distribution side with pharmacies, that they're not always stocking, because of the DEA oversight. What we've understood is that some of these models for distribution can consolidate the regulations and the oversight, both on the telehealth providers as well as for the distribution. That's what we're exploring right now to start as a pilot in 2026. We definitely anticipate that this could, in addition to our current model, be on top of that, we would anticipate that as we can get this up and running, it would have some forward momentum on our sales for. For QUVIVIQ, we would also expect that given its efficiency, we could, at some point, it would have impact as having a lower OpEx. DTP models are common now or getting more and more common in the United States. We would anticipate that if we were to make other products like TRYVIO available through that model, it might actually have an impact. The current focus really is QUVIVIQ, especially because we have more experience with QUVIVIQ and understand the points of friction that were there for patients and prescribers. Moving on to your second question area of TRYVIO, and the ideal timeframe for our partnership in the U.S. I mean, with the approval, and the availability of TRYVIO in the U.S., obviously, our focus is to make sure that this is available to patients as soon as possible. We would actually love to scale. We know that patients are benefiting already from our focused efforts to introduce this in the top hypertension centers. Prescribers are very eager to make sure it's available to patients. We would absolutely love to be able to build on our very focused pre-launch work and scale that through partnership. You know, that is top priority for the company right now, is to be able to find a partner and move that forward as soon as possible. Our efforts to do all the work that we've done on distribution with Walgreens Specialty, our work with the hypertension centers, our work on the guidelines, and making sure that we're continuously present at conferences and hosting ad boards and working with KOLs is really to make this as turnkey as possible for a potential partner. We would love to make sure that, you know, as they as we find that partner in the US, that they are able to make TRYVIO available to more and more patients. In terms of your questions on guidance, I'll start with that, and then I'll hand it over to Arno. I think right now the company is really focused on guiding on a one-year timeline. I think with the catalytic events and sort of the unknowns with things like descheduling, the partnership timeline, it's not meaningful to guide beyond a year. Our 2027 outlook that we provided in May 2025, at the time, it was the best available information we had. Of course, as we move forward, we are seeing more data. We see potentially, we could see the descheduling, we could get more information on partnership. Our forward-looking guidance could change, you know, in the next year. I think 2026 is actually quite a shaping year for us. With that, I'll hand it over to Arno to see if he has anything to add. Yeah, maybe also to take it a bit broader, because, I mean, the outlook that we gave in May 2025 was in the context of the whole financial restructuring. I think after that, with the 2025 performance and the guys for 2026, and in particular, the growth of QUVIVIQ sales, we are really making clear steps to profitability and cash flow break even. That the 2025 sales were in line with our guidance and our guidance for 2026 is also in line with what we said in May 2025. Like Srishti said, I mean, going forward, we will limit our guidance to the current year. There are many variables and inflection points in 2026 and onwards, in commercial, in partnerships, and also with our pipeline. Considering these moving parts, I think giving guidance beyond 2026 would not be meaningful for the market, and we would like to stay credible and transparent with guiding on numbers where we have a solid visibility. Thank you. Next question. Yes, of course. Now we're going to take our next question. The question comes line of Joris Zimmermann from Octavian. Your line is open. Please ask your question. Yeah. Hi, everyone. This is Joris Zimmermann from Octavian speaking. Thank you so much for taking my questions. Two, if I may. First on the QUVIVIQ pediatric data that you expect later this year in, I think, Q2. What is the immediate impact that you expect, and kind of the next steps that would follow those data? Also a bit from a longer-term perspective, what's your strategy here? Will you pursue an updated label? Does it have, does it come with a pediatric extension as well? That would be on QUVIVIQ. The second question on your cash and cash reach. With the current cash of around CHF 89 million and the CHF 80 million remaining from the new money facility, how would you assess your funding situation? Kind of, what is the estimated cash reach? Does that include all the costs to cover the kind of to drive your pipeline assets and to reach all the key inflection point that you outlined in the presentation? Thank you. Joris, thank you for joining, and thank you for the questions. I'll take the first one and hand the second one over to Arno. On the pediatric QUVIVIQ daridorexant study that is, we're expecting in Q2 2026. It's a dose-finding study, so the. We tested through in three doses and we'll do a dose-response curve. What we're expecting, hopefully, to see is both positive results with daridorexant in insomnia in the pediatric population, as well as to get some data on the dose. The next step would then be to take that information to the regulators and agree on a pathway forward, both with the U.S. as the FDA as well as the EMA. You know, we would have to run a phase III program. We're expecting to be running a phase III program. We would like to shape that program, you know, based on the findings of the phase II. That's where we are on the data. I mean, we're very excited, though, because there is no FDA-approved therapy for insomnia in this pediatric population, and there are no other doors with the safety profile that does non-sedative to work on the wake signal in this population. As we know from the data that we have in the adult populations that we use all around the world, the daytime functioning could have a huge impact for pediatric patients as well. We're very curious to see how the phase II results pan out, and we're very curious to be able to shape a phase three program that is able to do that later. The other part of it, for me, that's very exciting, is that there's, you know, the huge safety of halo that comes from having a product that's effective in the pediatric population, and especially in the United States, where we've, you know, had the burden of being a Schedule IV product. We would love to be able to have the safety halo that comes from showing use in the children with insomnia. With that, I'll hand it over to Arno. Yeah. Thanks, Joris, for your question about the cash and the cash reach. I think we're very fortunate that we have a very strong liquidity at the end of the year. With another CHF 69 million, we clearly have sufficient cash to bring us to the next inflection points. As already mentioned by Srishti, with the previous question, I mean, there are many variables and inflection points to come, so that will also clearly have an impact on our cash needs going forward. For now, I'm pretty happy with the cash runway that we have and that we're able to reach the inflection points based on which we can take additional decisions on whether to further invest or not. Next question. Next question. Of course. Thank you. Now we're going to take our next question. The next question comes line of Niall Alexander from Deutsche Bank. Your line is open. Please ask your question. Hi, it's Niall Alexander from Deutsche Bank. Thank you very much for taking my question. I guess maybe just moving to the pipeline, just on your CXCR7 antagonist in MS, I understand it is just a proof of concept right now, but it'd be helpful to understand how you feel this mechanism could potentially be differentiating, especially so to the likes of the CD20s right now, or even the BTKs in the space. Just trying to understand what your hypothesis or views are on the mechanism. Then the same applies to the CCR6 and CCL20 in psoriasis. Just wondering how the mechanism there can potentially be different from the likes of IL-17s and 23s in the space. Thank you very much. Thank you, Niall, for the questions. Maybe I'll start with CCR6 first, because that's the one that's enrolling right now. It's a first-in-class oral small molecule, and it's selective for the CCL20-driven recruitment of the pathogenic CCR6 expressing immune cells. First thing I think is the potential for an oral therapy that delivers a biologic-like efficacy, and then that's very compelling. We've designed the trial that evaluates the speed and the magnitude of the response, as well as the dose, performance and safety in the T helper 17-driven psoriasis in the PASI. The reason we went with that test, as well as with this, with psoriasis, is because that mechanism is the most clean. I think we don't see sort of off target in that, in that area, so we were really hoping that we could get a cleaner response on the PASI. A positive outcome in this proof of concept would confirm that in the mechanistic validation and the expansion to other associated indications. That's kind of what we're thinking about for CCR6. In terms of CXCR7 and the kind of the unique or the differentiating is that we have this oral again, that is both potentially anti-inflammatory as well as remyelinating. The brain penetrating potential is quite strong, which would have an impact to be able to transform the treatment paradigm in the MS. The proof of concept is primarily the progression of the multiple sclerosis. What we're trying to see is if we can, through it's imaging, yeah, it's really via imaging, we could see a slowing of the demyelination. That's kind of our, the proof of concept that we've designed for the CXCR7. Understood. Thank you. Thank you so much. Now we're going to take our next question, and the question comes line of Sushila Hernandez from Van Lanschot Kempen. Your line is open. Please ask a question. Hi, this is Sandrine on for Sushila. Thank you for taking our questions. We have two. First, could you provide more of an update on the QUVIVIQ descheduling process? Like, how likely is it that it will happen this year? Second, on the Fabry disease, now that you've reached alignment with the FDA, what are the next steps? Like, when will you start the kidney and the renal studies? Thank you, Sandrine, and thank you for joining. On the first question on descheduling, we expect the next major update to be the initiation of the public comment period from the DEA. That's the next time we think we'll have public information available on the descheduling process. In terms of where we are, I mean, we've now, you know, seen that we have probably around 13 million patients, ex-U.S., that have been on QUVIVIQ, across the globe between Japan, China, and Europe, and, you know, the 2 million patients in the U.S. We consistently know that QUVIVIQ is valued for its safe, for its safety. We don't see any meaningful signals of abuse, dependence, or withdrawal. Part of our update to the FDA has been to share this kind of comprehensive ex-U.S. data. This is on top of, you know, the Citizen Petition from 23 and a recent update that we did to the FAERS analysis. The FAERS is the FDA's own adverse event reporting system database, and where we again went back to the database and we did an updated analysis, and we demonstrate that the QUVIVIQ class has significantly reporting odds for adverse events related to drug abuse compared to the Z drugs and other non-schedule drugs, such as trazodone, which are used in the U.S. off-label. We're kind of combining those things in our mind and hoping that the FDA's recommendation that moves forward is to be descheduled, but we'll only know when the DEA opens it for public comment. That being said, I think it's important to know that we're not waiting for the descheduling to unlock the value of QUVIVIQ in the U.S. The daytime functioning in the label, the label-enhancing study, as well as the work with the direct-to-patient, We're setting up the model on direct to patient to be able to accommodate for the current schedule, as well as then expand based on any descheduling that happens. We are really focused on making sure that even in its current form, that we can increase access for patients, and they can have the benefit. Then, of course, all of those things in total, as we get more and more patients on QUVIVIQ, we can update the FDA with the safety profile and the lack of abuse signals. That's the question, I think, probably on descheduling, but we'll only know when it goes from the DEA into public comment. On Fabry, we're expecting to initiate the pivotal study for the biopsy in this year. So that's the pivotal, that's the 16 patients. I showed it earlier. It's baseline controlled. We're expecting to take patients that are treatment naive or pseudo-naive, and it's 18 months of treatment, and we're expecting that's in. It's in our budget to be starting that study this year. Soon thereafter, we'll do the second study, which is to show the switch from ERT. We'll take patients that have been on ERT therapy for a year or more, and we'll do the switch study, with the idea that we'd like to submit in 2029. Perfect. Thank you so much. Did I answer? Yeah. Yes. Perfect. Thank you. Thank you so much. Dear participants, as a reminder, if you wish to ask a question, please press star one one on your telephone keypad. Now we're going to take our next question. The question comes the line of Myles Minter from William Blair. Hey, thanks for, thanks for taking the questions. Congrats on the progress. Couple on lucerastat. Just wondering if you can comment on kind of the powering assumptions for that 74 patient renal function study that you're doing against ERT in Fabry. I noticed that the WORLDSymposium, you seem to see a greater efficacy signal in patients with, you know, pretty severe declines in eGFR at baseline and also anti-drug antibody-positive patients on the ERT side. I'm just wondering whether you're gonna stratify the readout of that trial in any way based on those factors. The final one is just in terms of the number of patients that remained in the open-label extension there. I think it was 47% of the original amount that crossed over. Can you just provide any sort of, you know, major reasons as to why there was discontinuations there? That would be very helpful. Thanks very much. Myles, thanks for joining, and thanks for the questions. I think your first question was on the power of the 70, the second study. We were not requested by the FDA to power the eGFR study, that's, you know, so we were working under the assumption that we don't have to have statistical significance, so we designed that study with that idea. In terms of the WORLDSymposium, the decline in the eGFR and the antibody and the stratification, I think we'll have to see where we are in terms of the eGFR study then, and the enrollment on how we might wanna stratify that study. Right now, as we're looking for a broad monotherapy label for all adult patients with Fabry, we're not looking to kind of have a specific use in those patients with ADA. We are trying to get the label to be as broad as possible. We would like to make sure that our study design is consistent with that. Finally, on the open label extension for MODIFY, that was 43 months, which was, I mean, I think six years, right? Like, we're in total with the six-month train, the six-month MODIFY trial. That's six years. I mean, 50% is actually a really good retention rate after six years. I don't know if there's anything I'm doing right now that's the same as I was doing six years ago. I think that retention rate actually seems pretty good for this type of study, for a chronic, for a daily oral and, with a chronic, for a chronic condition. Great. Thanks for the questions. Thank you. Now we're going to take our next question. The question comes line of Joris Zimmermann from Octavian. Your line is open. Please ask your question. Thank you. One more question from my end on the aprocitentan on partnering, if I may. I was just wondering, looking at, like, the data is there, the data is good. The first market feedback, to my understanding, is also very positive, and now you have the whole REMS requirements omitted, and you're even in the guidelines. I was wondering, what is it that is kind of, why do the aprocitentan on partnering discussions still go on? Can you maybe comment on that? Is it more on the finding the right partner in the U.S. and Europe, probably, or is it more on the deal terms? What's kind of the main discussion topic you're currently having here? Thank you, Joris, for the question. The third question, actually. On, I mean, you did a lot of the positives, right? We have the data, we have the market feedback, the REMS, we have the differentiation, especially for those patients that have an eGFR down to 15, where there are no other options. You know, we've been in a process of looking for a partner for a while. I mean, especially even to the time when J&J decided to not pursue work in cardiovascular anymore, we took the rights back for Apro so that we could bring it forward. We have such conviction in the endothelin receptor antagonist space and its ability to be used in systemic hypertension. After the approval process, I think we have gotten into a point where having a commercial asset that has not had the ability to be resourced for a launch, that's a new mechanism of action, that is, needs to be introduced in a pretty complex healthcare system right now, with incredible cost pressure and with the commercial payer system that's, you know, highly under evolution with PBMs. You know, it's like every other week, a pharma company is being hauled into the White House. I think it's really important for partners to be able to understand the commercial fit. With a commercial stage asset, the commercial fit, I think from the partner perspective, is one of the things that needs to be worked out on both sides. Like, we need to see that they're able to resource that Apro or TRYVIO gets to the patients and are willing to put the effort to make sure that TRYVIO can reach the most patients. They also need to make sure that it fits with their programs, given that it's commercial stage. A lot of the sort of the sweet spot for most deals is kind of a little bit before phase III or, you know, at this de-risking stage where they can prepare the market. I think right now we're, we're just, you know, in a peculiar stage with TRYVIO, but we are actively engaged in a, in a range of conversations. I think one last point to make is that the sort of complicated U.S. drug pricing system, and its implications for, internationally, are also impacting. That's why I think, we are exploring both global as well as regional partnerships. We have two different labels, two different brands, two doses, for TRYVIO/JERAYGO, and I think that gives us the flexibility to really pursue regional opportunities. That's also kind of evolved our focus on the partnership discussion. Thank you. Thank you, Joris. Dear speakers, please be advised there are no further questions for today. I would now like to hand the conference over to the management team for any closing remarks. Well, thank you everyone, for the time today. We will have our first quarter results on April 28th. Together with some of the participation that we have in investor conferences on this side of the Atlantic as well as in the U.S., we hope to get the opportunity to speak to more of you, in the near future. Thank you again for joining, and, with that, we can close the lines. This concludes today's conference call. Thank you for participating. You may now all disconnect. Have a nice day.